Browse Device Recalls
5,321 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,321 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 5,321 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Extension Set utilized in gravity IV administration sets and pump administrat... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Infusomat utilized in gravity IV administration sets and pump administration ... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | SafeDAY set utilized in gravity IV administration sets and pump administratio... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Blood Administration Set utilized in gravity IV administration sets and pump ... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Blood Administration Set utilized in gravity IV administration sets and pump ... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 24, 2025 | Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening ... | Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which... | Class II | GE Medical Systems, LLC |
| Oct 20, 2025 | Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labe... | Potential for anesthesia leakage. | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Oct 20, 2025 | Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 | Medtronic personnel observed trace amounts of dry blood on the external carton label and Instruct... | Class II | Medtronic Perfusion Systems |
| Oct 20, 2025 | Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. La... | Potential for anesthesia leakage. | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Oct 9, 2025 | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... | Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... | Class II | Thoratec LLC |
| Oct 6, 2025 | OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materi... | A labeling error was identified on the affected product. The expiration date on the kit box label... | Class III | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC P... |
| Oct 1, 2025 | Automated Impella Controller (AIC), used for left heart support blood pump, l... | Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella ... | Class I | Abiomed, Inc. |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; ... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597 | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ016... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ3... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF C... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261A... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS86001... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF ... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CD... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 26, 2025 | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 0... | Although the etched length on the screw is correct, the length marked on the external packaging i... | Class II | Synthes (USA) Products LLC |
| Sep 26, 2025 | Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm ... | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit... | Class II | Zimmer, Inc. |
| Sep 26, 2025 | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 0... | Although the etched length on the screw is correct, the length marked on the external packaging i... | Class II | Synthes (USA) Products LLC |
| Sep 26, 2025 | Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm ... | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit... | Class II | Zimmer, Inc. |
| Sep 25, 2025 | Artegraft¿ Collagen Vascular Graft; REF: AG1015; | The device was incorrectly packed in the wrong size labeled outer packaging. | Class II | LeMaitre Vascular, Inc. |
| Sep 23, 2025 | BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Aut... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: ... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX,... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), C... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 S... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD EpiCenter Microbiology Data Management System, labeled as the following: ... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 17, 2025 | InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE PO... | InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in f... | Class II | Enterix, Inc. |
| Sep 16, 2025 | Catalyft PL & PL40 Expandable Interbody System labeled as follows with corres... | Expandable interbody system cage may loose height or collapse (loss of lordosis), which could res... | Class II | Medtronic Sofamor Danek USA 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.