Browse Device Recalls
709 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 709 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 709 FDA device recalls in NC.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 17, 2022 | Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-040... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-040... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN00... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IP... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 12, 2022 | Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, ... | Scissors contained debris. | Class II | Medical Action Industries, Inc. 306 |
| Oct 12, 2022 | Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), ... | The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label ... | Class II | Medical Action Industries, Inc. 306 |
| Sep 28, 2022 | Pilling Wecksorb Cylindrical Sponges | Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the a... | Class II | TELEFLEX LLC |
| Sep 20, 2022 | Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Ki... | Product may not be sterile | Class II | TELEFLEX LLC |
| Sep 15, 2022 | B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (car... | The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10... | Class II | Medical Action Industries, Inc. 306 |
| Sep 14, 2022 | ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 ... | Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affe... | Class II | ARROW INTERNATIONAL Inc. |
| Aug 29, 2022 | Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 29, 2022 | Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 29, 2022 | Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circ... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 29, 2022 | Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical ga... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 29, 2022 | Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only;... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 29, 2022 | Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS on... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 16, 2022 | ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF ... | impaired functionality of the release liner | Class II | ConvaTec, Inc |
| Aug 16, 2022 | ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, RE... | impaired functionality of the release liner | Class II | ConvaTec, Inc |
| Aug 16, 2022 | ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, RE... | impaired functionality of the release liner | Class II | ConvaTec, Inc |
| Aug 16, 2022 | ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF ... | impaired functionality of the release liner | Class II | ConvaTec, Inc |
| Jul 20, 2022 | NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit. | There is a potential of no result leading to possible delayed result due to contamination of extr... | Class II | bioMerieux, Inc. |
| Jul 13, 2022 | VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only),... | There are 7 reported software anomalies that may affect use of the device. | Class II | bioMerieux, Inc. |
| May 5, 2022 | Arrow Three-Lumen CVC | Gravity flow rates on the affected product lidstock are incorrect. | Class II | ARROW INTERNATIONAL Inc. |
| Apr 22, 2022 | SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contai... | Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, sk... | Class II | ConvaTec, Inc |
| Apr 11, 2022 | (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Fle... | Reports received of torn corrugated breathing tubes. | Class II | TELEFLEX MEDICAL INC |
| Apr 11, 2022 | (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-... | Reports received of torn corrugated breathing tubes. | Class II | TELEFLEX MEDICAL INC |
| Mar 30, 2022 | Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22... | During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instrumen... | Class II | restor3d Inc. |
| Mar 30, 2022 | Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the... | Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium. | Class II | restor3d Inc. |
| Mar 30, 2022 | Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-2018101... | During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instrumen... | Class II | restor3d Inc. |
| Mar 29, 2022 | VITEK 2 Systems and VITEK 2 with MYLA. | Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and syner... | Class II | bioMerieux, Inc. |
| Feb 9, 2022 | VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. | Invalid calibrations (out of range high) while using the product. | Class II | bioMerieux, Inc. |
| Feb 1, 2022 | (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped... | The folding boxes within the shipping case are mislabeled. The shipping case and immediate packa... | Class II | BSN Medical Inc |
| Jan 11, 2022 | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... | The firm received reports indicating PTD tip separation during use. | Class I | TELEFLEX MEDICAL INC |
| Jan 11, 2022 | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... | The firm received reports indicating PTD tip separation during use. | Class I | TELEFLEX MEDICAL INC |
| Jan 11, 2022 | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containi... | The firm received reports indicating PTD tip separation during use. | Class I | TELEFLEX MEDICAL INC |
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.