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American Contract Systems Inc FDA Recalls
194 recalls on file across devices, 3 of them Class I and 193 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
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| American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90HClass IIJun 29, 2026The Convenience Kits contain Medline's Red Rubber Intermitte |
| American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AMClass IIJun 29, 2026The Convenience Kits contain Medline s Red Rubber Intermitte |
| American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10ANClass IIJun 29, 2026The Convenience Kits contain Medline s Red Rubber Intermitte |
| American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10APClass IIJun 29, 2026The Convenience Kits contain Medline s Red Rubber Intermitte |
| American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCPClass IIMay 19, 2026The recall notice was initiated due to a Medicom Urgent Medi |
| American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model ItemClass IIMay 19, 2026The recall notice was initiated due to a Medicom Urgent Medi |
| Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK MoClass IMar 19, 2026Impacted kits contain syringes recalled by Medline Industrie |
| Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15Class IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits UDPG88W PICC G-TUBE PACK-230209Class IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACKClass IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17Class IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELClass IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNClass IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENClass IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHYClass IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951Class IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits IHDC30R D AND C PACKClass IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACClass IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANClass IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATHClass IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Basic Biopsy Tray, Item Number NMBP44LClass IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BAClass IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACClass IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIClass IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACClass IISep 4, 2025Identified products were re-gassed (sterilized more than onc |
| AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH4Class IIJul 14, 2025During an internal investigation, ACS determined that the ra |
| AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10EClass IIJul 14, 2025During an internal investigation, ACS determined that the ra |
| AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCClass IIJul 14, 2025During an internal investigation, ACS determined that the ra |
| AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBClass IIJul 14, 2025During an internal investigation, ACS determined that the ra |
| AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUClass IIJul 14, 2025During an internal investigation, ACS determined that the ra |
| AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Class IIJul 14, 2025During an internal investigation, ACS determined that the ra |
| AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L;Class IIJul 14, 2025During an internal investigation, ACS determined that the ra |
| AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61Class IIJul 14, 2025During an internal investigation, ACS determined that the ra |
| AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSClass IIJul 14, 2025During an internal investigation, ACS determined that the ra |
| LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Class IIApr 21, 2025Test results for cast padding component included in procedur |
| CV BASIC PUMP PACK , Model No WECV23DClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| LABOR & DELIVERY PACK, Model Nos LLLD19HClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| THORACIC PACK , Model No UTTC82Y UTTC82AA-01Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| CYSTO , Model No SACY80RClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| SPINE LUMBAR PACK , Model No UTSL72AA UTSL72ABClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01IClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| DELIVERY PACK , Model No SGDV22D-01 SGDV22EClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| DIAGNOSTIC NEURO IR TRAY , Model No WENE21Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| NEURO IR TRAY , Model No WENI56JClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07BClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| TOTAL HIP PACK , Model No SMTH06O SMTH06PClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| LAPAROSCOPY PACK , Model No SFLA02A SFLA02BClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| EAR PACK , Model No SFEA12AClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| BORN ON ARRIVAL KIT , Model No LLBN11BClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07BClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| AV FISTULA , Model No UTAV77TClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41GClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| C-SECTION PACK, Model Nos LLCS44F LLCS44F-01Class IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73HClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| CYSTO PACK , Model N. HKCY31AClass IIFeb 6, 2025ACS is unable to confirm product sterilization assurance req |
| CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.Class IIFeb 4, 2025During an internal investigation, ACS was unable to confirm |
| Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G SofClass IIJan 31, 2025Sterility assurance with procedure trays |
| Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: ConveniClass IIJan 31, 2025Sterility assurance with procedure trays |
| Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/AClass IIJan 31, 2025Sterility assurance with procedure trays |
| Day Surgery General Pack, FHGE18T; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Endovascular AAA Pack, ESED52B; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Shoulder, SESH18I; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Endovascular AAA Pack, ESED52B; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Open Shoulder, LWOS39L; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Hand Pack, AKHD97C; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Neuro Vascular, ANKV91A; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Paracentesis Thoracente, SLPT76H; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| PACEMAKER PACK, SLCV01J; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| IR Procedure Pack, CEAT19W; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Pacemaker, COPM11B; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Vaginal Delivery, ASDV25B; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| ENT, COEN27N; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Arthroscopy Pack, MSKA45A; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Cysto, FTCY03L; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Nasal Sinus Pack, MTSN26B; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| Cath Lab Pack, CECL02P; Medical convenience kitClass IIAug 7, 2024ACS identified that due to an inoperable chart recorder, hum |
| TOTAL KNEE, ST LUKES Catalog Number: LMTK17APClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21EClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AFClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67FClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| KNEE SCOPE Procedure tray Catalog Number: COKN48LClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AGClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65AClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| HAND PACK-Procedure Kit Catalog Number: WEHD16BClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AGClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| TOTAL KNEE-Procedure Kit Catalog Number: SMTK21CClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23BClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56XClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49BClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10KClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| TOTAL KNEE-Procedure Kit Catalog Number: SFTK54BClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17CClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AAClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| HAND PACK-Procedure Kit Catalog Number: WEHD16CClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| TOTAL KNEE -Procedure Kit Catalog Number: QPTK95AClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35AClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14GClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50KClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22VClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01ZClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46BClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| TOTAL KNEE -Procedure Kit Catalog Number: QPTK95BClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10LClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17BClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AAClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15CClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AAClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22UClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| KNEE ARTHROSCOPY PACK Catalog Number: MEKA12RClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44SClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AEClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51BClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60AClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15BClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| HAND PACK 297829--Procedure Kit Catalog Number: RGHN04IClass IIMay 15, 2024Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for |
| American Contract Systems Special Procedure Pack convenience kitClass IIMay 6, 2024Product released with insufficient aeration time impacting t |
| American Contract Systems Hand Pack convenience kitClass IIMay 6, 2024Product released with insufficient aeration time impacting t |
| American Contract Systems Gyn Laparoscopy convenience kitClass IIMay 6, 2024Product released with insufficient aeration time impacting t |
| American Contract Systems Spine Pack convenience kitClass IIMay 6, 2024Product released with insufficient aeration time impacting t |
| American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenienceClass IIMay 6, 2024Product released with insufficient aeration time impacting t |
| American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American CClass IIMay 6, 2024Product released with insufficient aeration time impacting t |
| American Contract Systems Biopsy Drape Pack convenience kitClass IIMay 6, 2024Product released with insufficient aeration time impacting t |
| American Contract Systems Cataract Pack convenience kitClass IIMay 6, 2024Product released with insufficient aeration time impacting t |
| Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G;Class IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIClass IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kitClass IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) LamineClass IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; Class IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, Class IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J;Class IINov 29, 2023During an internal investigation, ACS identified that severa |
| Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LABClass IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit nClass IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit numClass IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit Class IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J;Class IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit numClass IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTClass IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21Class IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC,Class IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52;Class IINov 29, 2023During an internal investigation, ACS identified that severa |
| Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA0Class IINov 29, 2023During an internal investigation, ACS identified that severa |
| Pediatric Urology Wolson Pack, REF BPPU55AClass IISep 1, 2023During an internal investigation, ACS identified that the co |
| Robotics Pack SAH, REF SAR530MClass IISep 1, 2023During an internal investigation, ACS identified that the co |
| Sub Q Recorder Pack, REF BPRC87AClass IISep 1, 2023During an internal investigation, ACS identified that the co |
| Robotics Pack, REF SJVO56BClass IISep 1, 2023During an internal investigation, ACS identified that the co |
| Robotics Pack, REF SSRO22DClass IISep 1, 2023During an internal investigation, ACS identified that the co |
| Vasc. Open CVOR SJH, REF SJVO56BClass IISep 1, 2023During an internal investigation, ACS identified that the co |
| Pediatric Heart SJH, REF SJPH34KClass IISep 1, 2023During an internal investigation, ACS identified that the co |
| Cath Cardiac Pack, REF IHCC03VClass IISep 1, 2023During an internal investigation, ACS identified that the co |
| General Pack, REF BBGP31CClass IISep 1, 2023During an internal investigation, ACS identified that the co |
| Breast Plastics Pack, REF BBPL20DClass IISep 1, 2023During an internal investigation, ACS identified that the co |
| CVS PCSU SJH, REF SJCV48JClass IISep 1, 2023During an internal investigation, ACS identified that the co |
| LAVH, REF BBLV21CClass IISep 1, 2023During an internal investigation, ACS identified that the co |
| Total Knee Pack, REF CETJ130, medical convenience kitsClass IIIApr 17, 2023Incorrect expiration date on product. |
| BASIN SET, MEBS42K, general surgical kitClass IIOct 12, 2022Basin Set labeling error: components within the kit are for |
| COVID Test Kit NonsterileClass IIAug 12, 2022Kit incorrectly labeled for use with COVID testing and shoul |
| Various convenience packsClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Various eye packs, cataract packsClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Various PICC Line, Central Line PacksClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Various Port Insertion PacksClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| D&C packClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Various hysterectomy, vaginal packsClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Various ob/gyn packsClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Various convenience packsClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Various ENT PacksClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Various Pacemaker Packs, Cardio Thoracic PacksClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Various C-section packsClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Various Angiography packs/traysClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Various neurology packsClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Various Laparoscopy PacksClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Various Angiography/Cath Lab packs/traysClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Various Cysto PacksClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Breast Abdominoplasty PackClass IIJun 16, 2022Product was exposed to multiple sterilization cycles without |
| Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18AClass IMay 2, 2022Affected products were assembled off-site by individuals who |
| Clean Catch Urine Kit NS 178489, AHMU58AClass IMay 2, 2022Affected products were assembled off-site by individuals who |
| 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up TrayClass IIMar 22, 2022Product was sterilized with a higher than specification EO c |
| 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand PackClass IIMar 22, 2022Product was sterilized with a higher than specification EO c |
| ACS IR - Angio PackClass IIMar 22, 2022Product was sterilized with a higher than specification EO c |
| ACS Cath Lab PackClass IIMar 22, 2022Product was sterilized with a higher than specification EO c |
| ACS Lap Chole PackClass IIMar 22, 2022Product was sterilized with a higher than specification EO c |