Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 12, 2024 | BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FA... | Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube a... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Aug 12, 2024 | Seer Home System is an ambulatory electroencephalograph (EEG) system intended... | During CAPA investigations of sight production inconsistencies, it was highlighted that previous ... | Class II | SEER MEDICAL PTY LTD |
| Aug 12, 2024 | ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixatio... | Product packaging process may result in an improper or incomplete seal of the outer foil pouch su... | Class II | Smith & Nephew Inc. |
| Aug 12, 2024 | Custom Procedure Kit, REF: K12T-11077 | 7F sheath introducers labeled as 7.5F | Class II | Merit Medical Systems, Inc. |
| Aug 9, 2024 | GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant war... | GE HealthCare has become aware that complete electrical safety testing was not conducted during m... | Class II | Wipro GE Healthcare Private Ltd. |
| Aug 9, 2024 | STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL ... | Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as ... | Class II | Physio-Control, Inc. |
| Aug 9, 2024 | GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1... | GE HealthCare has become aware that complete electrical safety testing was not conducted during m... | Class II | Wipro GE Healthcare Private Ltd. |
| Aug 9, 2024 | Vios Monitoring System Bedside Monitor Model BSM2050 | Batteries may deplete over time while not in use if devices are stored without being plugged in t... | Class II | Murata Vios, Inc. |
| Aug 8, 2024 | ViewPoint; system, imaging processing, radiological | The National Institute of Standards and Technology (NIST) has identified in the National Vulnerab... | Class II | GE Healthcare GmbH |
| Aug 8, 2024 | Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use i... | Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck ... | Class II | Zimmer GmbH |
| Aug 8, 2024 | Fusion Pro 24, Model 17000 | a. A small number of Fusion Pro 24 units were released with an incorrectly placed Interlock devic... | Class II | Epilog Laser Corp. |
| Aug 8, 2024 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... | Firm has developed a software correction (Revision D.01) for outside the US to mitigate product p... | Class I | Datascope Corp. |
| Aug 8, 2024 | AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifo... | Potential for product leakage from the Spin Lock Connector on the distal end of the device due to... | Class II | B. Braun Medical, Inc. |
| Aug 8, 2024 | Ziehm Vision 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 Vision RFD 3D. Interventinoal 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 | Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) wit... | Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware... | Class II | Fresenius Medical Care Holdings, Inc. |
| Aug 8, 2024 | Ziehm Vision R. Iterventional 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 Vision system, x-ray, tomography, computed. | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... | Class II | Orthoscan, Inc. |
| Aug 8, 2024 | eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal | On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals ... | Class III | T.G. Eakin Limited |
| Aug 8, 2024 | CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... | Firm has developed a software correction (Revision D.01) for outside the US to mitigate product p... | Class I | Datascope Corp. |
| 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. |
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.