Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 8, 2024 | ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591... | The National Institute of Standards and Technology (NIST) has identified in the National Vulnerab... | Class II | GE Healthcare GmbH |
| Aug 8, 2024 | CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... | Firm has developed a software correction (Revision D.00) outside the US to mitigate product probl... | Class I | Datascope Corp. |
| Aug 8, 2024 | Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluorosco... | A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt. | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 8, 2024 | DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, ... | Material with a quality issue was used in contact lens production, so contact lenses may not meet... | Class II | Alcon Research LLC |
| Aug 8, 2024 | Ziehm Vision RFD. Interventional fluoroscopic x-ray system | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... | Class II | Orthoscan, Inc. |
| Aug 8, 2024 | Ziehm Solo FD. Interventional fluoroscopic x-ray system | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... | Class II | Orthoscan, Inc. |
| Aug 8, 2024 | Ziehm Solo. Digital Mobile C-arm | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... | Class II | Orthoscan, Inc. |
| Aug 8, 2024 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... | Firm has developed a software correction (Revision D.00) outside the US to mitigate product probl... | Class I | Datascope Corp. |
| Aug 8, 2024 | Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in to... | Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck ... | Class II | Zimmer GmbH |
| Aug 7, 2024 | Open Shoulder, LWOS39L; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue ... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Arthroscopy Pack, MSKA45A; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue ... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U | Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2... | Class II | BioFire Diagnostics, LLC |
| Aug 7, 2024 | ENT, COEN27N; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce ... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U | Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to... | Class I | B Braun Medical Inc |
| Aug 7, 2024 | Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissu... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Endovascular AAA Pack, ESED52B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Day Surgery General Pack, FHGE18T; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue ... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissu... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue ... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Cysto, FTCY03L; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce ... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Shoulder, SESH18I; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W | Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2... | Class II | BioFire Diagnostics, LLC |
| Aug 7, 2024 | Endovascular AAA Pack, ESED52B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/o... | Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the... | Class II | Fisher & Paykel Healthcare, Ltd. |
| Aug 7, 2024 | Cath Lab Pack, CECL02P; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Paracentesis Thoracente, SLPT76H; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissu... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce ... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Neuro Vascular, ANKV91A; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | PACEMAKER PACK, SLCV01J; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Nasal Sinus Pack, MTSN26B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | IR Procedure Pack, CEAT19W; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 | Stryker has identified an issue with the characterization process that impacted the constant valu... | Class II | Howmedica Osteonics Corp. |
| Aug 7, 2024 | Vaginal Delivery, ASDV25B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue ... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Hand Pack, AKHD97C; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in th... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Pacemaker, COPM11B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 6, 2024 | General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog ... | The syringes that were inadvertently shipped from the Distribution Center. This product was on qu... | Class II | Cypress Medical Products LLC |
| Aug 6, 2024 | Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventio... | The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eve... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 Set AU; Product Code: 1000361; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Pump 371 14F LT CMR Set; Product Code: 0048-0045; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, 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.