← Every firm
Cardinal Health 200, LLC FDA Recalls
203 recalls on file across devices, drugs, 32 of them Class I and 169 still open. Matched by name to CAH.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HANClass IIAug 10, 2026The kits contain applicators that may exhibit an open or inc |
| Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV Class IIAug 10, 2026The kits contain applicators that may exhibit an open or inc |
| Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH Class IIJul 29, 2026The Urinary Catheter Trays contain CliniClean Pericare Wipes |
| Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST Class IIJul 29, 2026The Urinary Catheter Trays contain CliniClean Pericare Wipes |
| Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE Class IIJul 29, 2026The Urinary Catheter Trays contain CliniClean Pericare Wipes |
| Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KIClass IIJul 29, 2026The Urinary Catheter Trays contain CliniClean Pericare Wipes |
| Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM Class IIJul 29, 2026The Urinary Catheter Trays contain CliniClean Pericare Wipes |
| Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO ROBOTIC GYN Class IIJul 29, 2026The Urinary Catheter Trays contain CliniClean Pericare Wipes |
| Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH Class IIJul 29, 2026The Urinary Catheter Trays contain CliniClean Pericare Wipes |
| Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL PRESBYTERIAClass IIJul 29, 2026The Urinary Catheter Trays contain CliniClean Pericare Wipes |
| Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST Class IIJul 29, 2026The Urinary Catheter Trays contain CliniClean Pericare Wipes |
| Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX CIRCULATOR Class IIJul 29, 2026The Urinary Catheter Trays contain CliniClean Pericare Wipes |
| Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY Class IIJul 29, 2026The Urinary Catheter Trays contain CliniClean Pericare Wipes |
| Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B Class IIJul 29, 2026The Urinary Catheter Trays contain CliniClean Pericare Wipes |
| Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANClass IIJul 14, 2026Procedure kits contain MEDICOM Ritmed Neurological Sponges t |
| Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK Class IIJul 14, 2026Procedure kits contain MEDICOM Ritmed Neurological Sponges t |
| Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMBClass IIJul 14, 2026Procedure kits contain MEDICOM Ritmed Neurological Sponges t |
| Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OClass IIJul 14, 2026Procedure kits contain MEDICOM Ritmed Neurological Sponges t |
| Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO Class IIJul 14, 2026Procedure kits contain MEDICOM Ritmed Neurological Sponges t |
| Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS Class IIJul 14, 2026Procedure kits contain MEDICOM Ritmed Neurological Sponges t |
| Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD Class IIJul 14, 2026Procedure kits contain MEDICOM Ritmed Neurological Sponges t |
| Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCCClass IIJul 14, 2026Procedure kits contain MEDICOM Ritmed Neurological Sponges t |
| Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, WaClass IMar 2, 2026Non-Sterility: microbial contamination identified as Paeniba |
| Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777Class IIFeb 27, 2026The outer packaging and blister pack labeling identify the p |
| Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2.Class IIDec 26, 2025The firm is updating the IFU to clarify the intended patient |
| ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-Class IINov 12, 2025Affected gowns have the incorrect expiration date on the pro |
| Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve,Class IISep 18, 2025Firm has received complaints regarding Anti-Reflux Valve (AR |
| Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENClass IISep 18, 2025Firm has received complaints regarding Anti-Reflux Valve (AR |
| Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264Class IISep 18, 2025Firm has received complaints regarding Anti-Reflux Valve (AR |
| Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Class IISep 18, 2025Firm has received complaints regarding Anti-Reflux Valve (AR |
| Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Class IISep 18, 2025Firm has received complaints regarding Anti-Reflux Valve (AR |
| Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) xClass IISep 18, 2025Firm has received complaints regarding Anti-Reflux Valve (AR |
| Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SClass IIMay 13, 2025Incorrect software logic may cause frequent E1 errors (syste |
| SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow ConClass IIMay 13, 2025Incorrect software logic may cause frequent E1 errors (syste |
| Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall Class IIMay 13, 2025Incorrect software logic may cause frequent E1 errors (syste |
| Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumenClass IIMay 2, 2025Packaging defect may compromise sterility of the product. Us |
| Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCsClass IIMay 2, 2025Packaging defect may compromise sterility of the product. Us |
| Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumenClass IIMay 2, 2025Packaging defect may compromise sterility of the product. Us |
| Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumenClass IIMay 2, 2025Packaging defect may compromise sterility of the product. Us |
| Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumenClass IIMay 2, 2025Packaging defect may compromise sterility of the product. Us |
| Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumenClass IIMay 2, 2025Packaging defect may compromise sterility of the product. Us |
| Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number Class IINov 8, 2024Potential endotoxin contamination in non-sterile surgical st |
| Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASClass IINov 8, 2024Potential endotoxin contamination in non-sterile surgical st |
| Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESClass IINov 8, 2024Potential for endotoxin contamination in non-sterile surgica |
| Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog NumbClass IINov 8, 2024Potential endotoxin contamination in non-sterile surgical st |
| Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog NumClass IINov 8, 2024Potential endotoxin contamination in non-sterile surgical st |
| Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSMEClass IINov 8, 2024Potential endotoxin contamination in non-sterile surgical st |
| Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOClass IINov 8, 2024Potential for endotoxin contamination in non-sterile surgica |
| Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Class IINov 8, 2024Potential endotoxin contamination in non-sterile surgical st |
| Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCClass IINov 8, 2024Potential endotoxin contamination in non-sterile surgical st |
| Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP Class IINov 8, 2024Potential for endotoxin contamination in non-sterile surgica |
| Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog NumbeClass IINov 8, 2024Potential endotoxin contamination in non-sterile surgical st |
| Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog NumClass IINov 8, 2024Potential endotoxin contamination in non-sterile surgical st |
| Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, CatalogClass IINov 8, 2024Potential for endotoxin contamination in non-sterile surgica |
| Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, CaClass IINov 8, 2024Potential for endotoxin contamination in non-sterile surgica |
| Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAClass IINov 8, 2024Potential for endotoxin contamination in non-sterile surgica |
| Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog NClass IINov 8, 2024Potential for endotoxin contamination in non-sterile surgica |
| Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSONClass IINov 8, 2024Potential for endotoxin contamination in non-sterile surgica |
| Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCClass IINov 8, 2024Potential for endotoxin contamination in non-sterile surgica |
| Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;Class IINov 8, 2024Potential for endotoxin contamination in non-sterile surgica |
| Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCBClass IINov 8, 2024Potential for endotoxin contamination in non-sterile surgica |
| Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Class IINov 8, 2024Potential endotoxin contamination in non-sterile surgical st |
| Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, CClass IINov 8, 2024Potential for endotoxin contamination in non-sterile surgica |
| Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT658Class IINov 1, 2024Isolation Gowns were manufactured with raw materials that ma |
| Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XLClass IINov 1, 2024Isolation Gowns were manufactured with raw materials that ma |
| Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777Class ISep 25, 2024Certain lots of listed lots of Cardinal Health Monoject U-10 |
| (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile;Class IIJul 24, 2024The firm received reports of breakage in the Anti-Reflux Val |
| (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), ModelClass IIJul 24, 2024The firm received reports of breakage in the Anti-Reflux Val |
| Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog NuClass IIMay 29, 2024Cardinal Health is following the FDA's recommendations regar |
| Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac CatheteClass IIMay 29, 2024Cardinal Health is following the FDA's recommendations regar |
| Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular PClass IIMay 29, 2024Cardinal Health is following the FDA's recommendations regar |
| Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Class IIMay 29, 2024Cardinal Health is following the FDA's recommendations regar |
| CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, HypoallergeniClass IIApr 17, 2024Potential contamination of the product with latex adhesive r |
| Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403DClass IIMar 27, 2024Cardinal Health is issuing a lot number specific voluntary r |
| Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402DClass IIMar 27, 2024Cardinal Health is issuing a lot number specific voluntary r |
| Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475Class IIMar 27, 2024Cardinal Health is issuing a lot number specific voluntary r |
| Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601Class IIMar 27, 2024Cardinal Health is issuing a lot number specific voluntary r |
| Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401DClass IIMar 27, 2024Cardinal Health is issuing a lot number specific voluntary r |
| Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777Class IDec 28, 2023Cardinal Health is expanding their previous product correcti |
| Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777Class IDec 28, 2023Cardinal Health is expanding their previous product correcti |
| Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SEClass IDec 28, 2023The listed lots of Cardinal Health Monoject Enteral Syringes |
| Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777Class IDec 28, 2023Cardinal Health is expanding their previous product correcti |
| Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777TClass IDec 28, 2023Cardinal Health is expanding their previous product correcti |
| Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777Class IDec 28, 2023Cardinal Health is expanding their previous product correcti |
| Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SEClass IDec 28, 2023The listed lots of Cardinal Health Monoject Enteral Syringes |
| Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777Class IDec 28, 2023Cardinal Health is expanding their previous product correcti |
| Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777TClass IDec 28, 2023Cardinal Health is expanding their previous product correcti |
| Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SEClass IDec 28, 2023The listed lots of Cardinal Health Monoject Enteral Syringes |
| Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SEClass IDec 28, 2023Cardinal Health is expanding their previous product correcti |
| Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SEClass IDec 28, 2023Cardinal Health is expanding their previous product correcti |
| Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SEClass IDec 28, 2023The listed lots of Cardinal Health Monoject Enteral Syringes |
| Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651Class IIDec 21, 2023The above-listed lots of Cardinal Health Medi-Vac CRD" Sucti |
| CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510Class IIDec 21, 2023The above-listed lots of Cardinal Health Medi-Vac CRD" Sucti |
| Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651Class IIDec 21, 2023The above-listed lots of Cardinal Health Medi-Vac CRD" Sucti |
| Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICClass IDec 4, 2023Convenience kits were manufactured and distributed with comp |
| TRACH KIT W/HYDROGEN & SALIClass IDec 4, 2023Convenience kits were manufactured and distributed with comp |
| Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATEDClass IDec 4, 2023Convenience kits were manufactured and distributed with comp |
| Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATEClass IDec 4, 2023Convenience kits were manufactured and distributed with comp |
| Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BClass IDec 4, 2023Convenience kits were manufactured and distributed with comp |
| Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with ChiClass IDec 4, 2023Convenience kits were manufactured and distributed with comp |
| Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDEDClass IDec 4, 2023Convenience kits were manufactured and distributed with comp |
| Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400Class IDec 4, 2023Convenience kits were manufactured and distributed with comp |
| Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 4Class IDec 4, 2023Convenience kits were manufactured and distributed with comp |
| Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSDClass IDec 4, 2023Convenience kits were manufactured and distributed with comp |
| Monoject 20 mL Syringe Luer-Lock Tip Soft PackClass ISep 20, 2023Demonstrated recognition and compatibility issues with syrin |
| Monoject" 35 mL Syringe Luer-Lock Tip Soft PackClass ISep 20, 2023Demonstrated recognition and compatibility issues with syrin |
| Monoject" 60 mL Syringe Luer-Lock Tip Soft PackClass ISep 20, 2023Demonstrated recognition and compatibility issues with syrin |
| Monoject" 6 mL Syringe Luer-Lock Tip Soft PackClass ISep 20, 2023Demonstrated recognition and compatibility issues with syrin |
| Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft PackClass ISep 20, 2023Demonstrated recognition and compatibility issues with syrin |
| Monoject" 12 mL Syringe Luer-Lock Tip Soft PackClass ISep 20, 2023Demonstrated recognition and compatibility issues with syrin |
| Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777Class IISep 13, 2023Syringe contains conical tip that is not compatible with cer |
| Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2)Class IIAug 16, 2023Packs contain recalled components (equipment drapes, table c |
| Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.Class IIAug 16, 2023Packs contain recalled components (equipment drapes, table c |
| Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.Class IIAug 16, 2023Packs contain recalled components (equipment drapes, table c |
| Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; Class IIAug 16, 2023Packs contain recalled components (equipment drapes, table c |
| Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) PresClass IIAug 16, 2023Packs contain recalled components (equipment drapes, table c |
| Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.Class IIAug 16, 2023Packs contain recalled components (equipment drapes, table c |
| Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN AntClass IIAug 16, 2023XXX |
| Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and (2) PreClass IIAug 16, 2023Packs contain recalled components (equipment drapes, table c |
| Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, KitClass IIAug 16, 2023Packs contain recalled components (equipment drapes, table c |
| Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Class IIAug 16, 2023Packs contain recalled components (equipment drapes, table c |
| NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010Class IIJun 16, 2023Cardinal Health has received an increase in burst/leaking co |
| Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgeryClass IIApr 6, 2023Inadvertently released for distibution without sterility ass |
| Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2229Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231Class IIDec 14, 2022Cardinal Health recently received multiple complaints regard |
| Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798BClass IINov 18, 2022Presource Kits contains the ICU MicroClave Clear Connector |
| Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799AClass IINov 18, 2022Presource Kits contains the ICU MicroClave Clear Connector |
| Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553EClass IINov 18, 2022Presource Kits contains the ICU MicroClave Clear Connector |
| Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304AClass IISep 28, 2022Users are being informed that the product should not be used |
| Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204AClass IISep 28, 2022Users are being informed that the product should not be used |
| Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104Class IISep 28, 2022Users are being informed that the product should not be used |
| Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600Class IISep 28, 2022Users are being informed that the product should not be used |
| Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204Class IISep 28, 2022Users are being informed that the product should not be used |
| Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304Class IISep 28, 2022Users are being informed that the product should not be used |
| Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115Class IISep 28, 2022Users are being informed that the product should not be used |
| Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304AClass IISep 28, 2022Users are being informed that the product should not be used |
| Cardinal Health PROTEXIS PI and PI Classic, Surgical GlovesClass IIMar 15, 2022Product was distributed without being sterilized. |
| Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an UmbClass IJun 16, 2021The current Argyle UVC Insertion Tray does not include a spe |
| Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activaClass IIJun 9, 2021A caution statement is being added to remind the user to ac |
| Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activatedClass IIJun 9, 2021A caution statement is being added to remind the user to ac |
| Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intendClass IIMay 21, 2021The plastic film used to manufacture these Angiography Drape |
| Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protecClass IIMay 21, 2021The plastic film used to manufacture these Angiography Drape |
| Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as prClass IIMay 21, 2021The plastic film used to manufacture these Angiography Drape |
| Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be used as protective paClass IIMay 21, 2021The plastic film used to manufacture these Angiography Drape |
| Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be useClass IIMay 21, 2021The plastic film used to manufacture these Angiography Drape |
| Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as prClass IIMay 21, 2021The plastic film used to manufacture these Angiography Drape |
| Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to be used as protectiClass IIMay 21, 2021The plastic film used to manufacture these Angiography Drape |
| Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usage: intended to be used as protective patienClass IIMay 21, 2021The plastic film used to manufacture these Angiography Drape |
| In-View Clear Leggings SterileClass IIFeb 25, 2021Cardinal Health has determined that a manufacturing variance |
| Femoral Angiography Drape Bulk Non-SterileClass IIFeb 25, 2021Cardinal Health has determined that a manufacturing variance |
| In-View Clear Leggings Bulk Non-SterileClass IIFeb 25, 2021Cardinal Health has determined that a manufacturing variance |
| In-View Clear Leggings Sterile Non-SterileClass IIFeb 25, 2021Cardinal Health has determined that a manufacturing variance |
| Femoral Angiography Drape SterileClass IIFeb 25, 2021Cardinal Health has determined that a manufacturing variance |
| JUDKINS PACKClass IIFeb 11, 2021Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, |
| Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to Class IIFeb 9, 2021Safety shield not locking into the cannula. If the safety sh |
| McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inject fluids into, or wClass IIFeb 9, 2021Safety shield not locking into the cannula. If the safety sh |
| Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids intoClass IIFeb 9, 2021Safety shield not locking into the cannula. If the safety sh |
| Enteral Infusion PumpClass IIJan 19, 2021The potential for air appearing in the enteral feed pumping |
| ChemoPlus Drug Spill Kit-INSTI, SKU DP5016KClass IIJan 7, 2021Gowns included in the kits potentially have rips, holes, tea |
| ChemoPlus" Chemo Prep & Admin Kit, CT4025Class IIJan 7, 2021Gowns included in the kits potentially have rips, holes, tea |
| Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016KClass IIJan 7, 2021Gowns included in the kits potentially have rips, holes, tea |
| Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended tClass IIJan 7, 2021There is a potential for rips, holes, tears, incomplete and/ |
| Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108KClass IIJan 7, 2021Gowns included in the kits potentially have rips, holes, tea |
| Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to Class IIJan 7, 2021There is a potential for rips, holes, tears, incomplete and/ |
| Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to providClass IIJan 7, 2021There is a potential for rips, holes, tears, incomplete and/ |
| Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" GClass IIJan 7, 2021There is a potential for rips, holes, tears, incomplete and/ |
| Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to pClass IIJan 7, 2021There is a potential for rips, holes, tears, incomplete and/ |
| Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal Health Isolation Gown,Class IIJan 7, 2021There is a potential for rips, holes, tears, incomplete and/ |
| Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to prClass IIJan 7, 2021There is a potential for rips, holes, tears, incomplete and/ |
| Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to proClass IIJan 7, 2021There is a potential for rips, holes, tears, incomplete and/ |
| CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004Class IIJan 7, 2021Gowns included in the kits potentially have rips, holes, tea |
| Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to Class IIJan 7, 2021There is a potential for rips, holes, tears, incomplete and/ |
| Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to pClass IIJan 7, 2021There is a potential for rips, holes, tears, incomplete and/ |
| Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended toClass IIJan 7, 2021There is a potential for rips, holes, tears, incomplete and/ |
| Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provideClass IIJan 7, 2021There is a potential for rips, holes, tears, incomplete and/ |
| Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended toClass IIJan 7, 2021There is a potential for rips, holes, tears, incomplete and/ |
| CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106KClass IIJan 7, 2021Gowns included in the kits potentially have rips, holes, tea |