Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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-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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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-0.4 - 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 | 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 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 | Pump 381 Pump Set (US); Product Code: 1000080; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Smart Assist Set, Canada; Product Code: 0048-0044; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retriev... | Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years inste... | Class II | MICROVENTION 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.