← Every firm
Covidien, LP FDA Recalls
101 recalls on file across devices, 26 of them Class I and 98 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.
| Product |
|---|
| Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GXClass IIJun 24, 2026Product may contain a perforation or tear in the sterile bar |
| V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLClass IIJun 24, 2026Product may contain a perforation or tear in the sterile bar |
| Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-Class IIJun 24, 2026Product may contain a perforation or tear in the sterile bar |
| Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623Class IIJun 24, 2026Product may contain a perforation or tear in the sterile bar |
| V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX0740Class IIJun 24, 2026Product may contain a perforation or tear in the sterile bar |
| Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;Class IIApr 15, 2026The presence of holes in the pouch may compromise the packag |
| Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;Class IISep 25, 2025A manufacturing issue could lead to a malformed cover tube p |
| Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06Class IISep 25, 2025A manufacturing issue could lead to a malformed cover tube p |
| Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-Class IISep 19, 2024Specific lots of the Chameleon PTA Balloon Catheter failed t |
| Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgClass IIApr 15, 2024Potential damage to the cartridge can result in poor staple |
| Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, SilClass IIMar 15, 2024Products may not be heparin coated as indicated on the label |
| Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTClass IIMar 15, 2024Products may not be heparin coated as indicated on the label |
| Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNLClass IIFeb 28, 2024The potential for trocar seal disengagement when using mesh |
| Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTClass IIFeb 28, 2024The potential for trocar seal disengagement when using mesh |
| Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSClass IIFeb 28, 2024The potential for trocar seal disengagement when using mesh |
| Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNLClass IIFeb 28, 2024The potential for trocar seal disengagement when using mesh |
| Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNLClass IIFeb 28, 2024The potential for trocar seal disengagement when using mesh |
| Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SBClass IIFeb 28, 2024The potential for trocar seal disengagement when using mesh |
| Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTClass IIFeb 28, 2024The potential for trocar seal disengagement when using mesh |
| Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVTClass IIFeb 14, 2024Under certain firing conditions, reloads were found to artic |
| Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVTClass IIFeb 14, 2024Under certain firing conditions, reloads were found to artic |
| Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of Class IIJan 25, 2024One lot of product was exposed to more than the approved num |
| Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILKClass IIDec 21, 2023Specific lots of sutures were sterilized with gamma doses th |
| Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 888Class IIDec 21, 2023Specific lots of sutures were sterilized with gamma doses th |
| AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material tClass IINov 16, 2023Packaging of the device may cause a low seal strength in the |
| Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cmClass IIAug 22, 2023Some catheter kits labeled as 23 cm implant length incorrect |
| MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HPClass IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HPClass IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HClass IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 88Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 888810300Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HPClass IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 88883Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 888810200Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HClass IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 888810300Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 888810300Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HPClass IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HClass IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888Class IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HPClass IJun 28, 2023Catheter center lumen was found to have an occlusion in the |
| VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STSClass IIMar 22, 2023There is a manufacturing non-conformance that may result in |
| VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STSClass IIMar 22, 2023There is a manufacturing non-conformance that may result in |
| VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STSClass IIMar 22, 2023There is a manufacturing non-conformance that may result in |
| Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIClass IIMar 1, 2023Medtronic was made aware of a supplier calibration issue dur |
| Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)Class IIMar 1, 2023Medtronic was made aware of a supplier calibration issue dur |
| Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number Class IIMar 1, 2023Medtronic was made aware of a supplier calibration issue dur |
| Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)Class IIMar 1, 2023Medtronic was made aware of a supplier calibration issue dur |
| Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXTClass IIJan 25, 2023Affected lots have the potential for a broken sled vane, whi |
| Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended foClass IIJan 11, 2023Collagen film was placed on the opposite side of the mesh ma |
| MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight ExtensiClass IDec 7, 2022There is a potential leaking condition within the hub of aff |
| Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRClass IIDec 2, 2022Sterile Barrier Breach of Breather Pouch may cause infection |
| Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPROClass IIDec 2, 2022Sterile Barrier Breach of Breather Pouch may cause infection |
| Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLKClass IIDec 2, 2022Sterile Barrier Breach of Breather Pouch may cause infection |
| Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DAClass IIDec 2, 2022Sterile Barrier Breach of Breather Pouch may cause infection |
| Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOClass IIDec 2, 2022Sterile Barrier Breach of Breather Pouch may cause infection |
| Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CMClass IIDec 2, 2022Sterile Barrier Breach of Breather Pouch may cause infection |
| Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVClass IIDec 2, 2022Sterile Barrier Breach of Breather Pouch may cause infection |
| Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P Class IIDec 2, 2022Sterile Barrier Breach of Breather Pouch may cause infection |
| Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOClass IIDec 2, 2022Sterile Barrier Breach of Breather Pouch may cause infection |
| Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 1Class IIDec 2, 2022Sterile Barrier Breach of Breather Pouch may cause infection |
| Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACKClass IIDec 2, 2022Sterile Barrier Breach of Breather Pouch may cause infection |
| Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLClass IISep 28, 2022Medtronic has received 210 reports of needles breaking durin |
| Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA3Class IISep 28, 2022Medtronic has received 210 reports of needles breaking durin |
| EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.Class IIMay 13, 2022The affected staplers have the potential for the staple guid |
| SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)Class IIDec 22, 2021Prior to use on a patient, the device alarm speaker failed t |
| Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023Class IIMay 28, 2021This voluntary withdrawal is being conducted to implement po |
| HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patientsClass IIApr 29, 2021The company was notified by their supplier of sterilization |
| Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anClass IIApr 29, 2021The company was notified by their supplier of sterilization |
| Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized Class IIApr 29, 2021The company was notified by their supplier of sterilization |
| Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and Class IIApr 29, 2021The company was notified by their supplier of sterilization |
| Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVTClass IIMar 4, 2021Potential for the device safety interlock to fail. The safet |
| Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTVClass IIMar 4, 2021Potential for the device safety interlock to fail. The safet |
| Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVTClass IIMar 4, 2021Potential for the device safety interlock to fail. The safet |