Browse Device Recalls
806 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 806 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 806 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 20, 2024 | PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLEN... | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... | Class II | Ethicon, LLC |
| Nov 6, 2024 | BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicil... | BD identified through potency testing as part of a stability test request to monitor Ampicillin A... | Class II | Becton Dickinson & Co. |
| Sep 25, 2024 | intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buff... | Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohi... | Class II | Biocare Medical, LLC |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO I... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | NxTAG Respiratory Pathogen Panel, REF: I051C0447 | Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence... | Class II | Luminex Molecular Diagnostics Inc |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468 | Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence... | Class II | Luminex Molecular Diagnostics Inc |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 3, 2024 | SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cro... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cros... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obta... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Aug 29, 2024 | Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrum... | Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobact... | Class II | Microcare Medical |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use i... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a ... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a phar... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 19, 2024 | IntelliSystem Inflation Device, REF: IN1525/D | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | StabiliT TOUCH Syringe, REF: IN8VCF/B | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixTOUCH Inflation Device, REF: IN8140/A | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | BlueFIRE Inflation Device, REF: IN10140 | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixSKY Inflation Device, REF: SKY1802 | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K0... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, I... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Jul 25, 2024 | Vivo 45 LS, pressure and volume ventilator capable of delivering continuous o... | There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the de... | Class I | Breas Medical, Inc. |
| Jun 24, 2024 | Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 56... | Any single affected ventilator should only be used for the 10- year labelled service life, but if... | Class I | Covidien |
| May 13, 2024 | Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh... | The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg... | Class II | Roche Diabetes Care, Inc. |
| May 3, 2024 | SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Med... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
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.