Browse Device Recalls
75 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 75 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 75 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 19, 2024 | Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH0... | Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure test... | Class II | Covidien LP |
| Mar 15, 2024 | Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Sym... | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... | Class II | Covidien LP |
| Mar 15, 2024 | Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 1... | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... | Class II | Covidien LP |
| Dec 21, 2023 | Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 ... | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The e... | Class II | Covidien LP |
| Dec 21, 2023 | Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 8... | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The e... | Class II | Covidien LP |
| Nov 16, 2023 | AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -int... | Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentia... | Class II | Covidien LP |
| Aug 22, 2023 | Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm | Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implan... | Class II | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensio... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensio... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extension... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Mar 22, 2023 | VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS | There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... | Class II | Covidien LP |
| Mar 22, 2023 | VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS | There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... | Class II | Covidien LP |
| Mar 22, 2023 | VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS | There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... | Class II | Covidien LP |
| Dec 7, 2022 | MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single... | There is a potential leaking condition within the hub of affected devices, due to an inter-lumen ... | Class I | Covidien LP |
| Jul 17, 2017 | Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Spon... | Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable s... | Class II | Covidien LP |
| Jan 15, 2016 | Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Int... | Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certai... | Class II | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jul 16, 2015 | Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality... | Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Vo... | Class I | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jun 29, 2015 | OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For c... | Potential missing segments on the display that can result in misinterpretation of data. | Class II | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jun 29, 2015 | OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of func... | Potential missing segments on the display that can result in misinterpretation of data. | Class II | Covidien LP (formerly Nellcor Puritan Bennett I... |
| May 8, 2015 | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGua... | Reports where patients who recently switched from the current Shiley Neonatal and Pediatric produ... | Class I | Covidien LP (formerly Nellcor Puritan Bennett I... |
| May 8, 2015 | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. M... | Reports where patients who recently switched from the current Shiley Neonatal and Pediatric produ... | Class I | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jan 12, 2015 | Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxx... | Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occas... | Class II | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Oct 1, 2014 | Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in ... | A software issue may lead to ventilator inoperative situations. | Class I | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Oct 1, 2014 | Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien ... | Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter... | Class I | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Jul 17, 2014 | Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other ... | Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform a... | Class II | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Jul 17, 2014 | Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other elect... | Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform a... | Class II | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Jun 4, 2014 | Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a compone... | In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator con... | Class II | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Jun 3, 2014 | Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator Syst... | Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventila... | Class II | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.