Browse Device Recalls

3,494 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,494 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 3,494 FDA device recalls in MA.

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DateProductReasonClassFirm
Sep 3, 2024 Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-secti... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional im... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional image... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Aug 30, 2024 IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 8... During a production process, Philips became aware of one IntelliVue power supply with a broken gr... Class II Philips North America
Aug 30, 2024 Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9... The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unres... Class I Fresenius Kabi USA, LLC
Aug 13, 2024 Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF,... This product labeling does not adequately provide warning about the risks associated with the use... Class II Zoe Medical Incorporated
Aug 13, 2024 Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT)... This product labeling does not adequately provide warning about the risks associated with the use... Class II Zoe Medical Incorporated
Aug 12, 2024 ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation ... 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 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 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 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.
Aug 5, 2024 Impella CP Pump Set, Japan; Product Code: 0048-0034-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, EU; Product Code: 0048-0014; 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 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 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 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 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 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 SmartAssist S2 Set, JP; Product Code: 1000459; 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; Product Code: 1000402; 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 APAC; Product Code: 0048-0047; 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, EU; Product Code: 0550-0002; A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... Class II Abiomed, Inc.
Aug 5, 2024 Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... Class II Abiomed, Inc.
Aug 5, 2024 Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... Class II Abiomed, Inc.
Aug 5, 2024 ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... Class II Abiomed, Inc.
Aug 1, 2024 AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covere... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal lumi... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covere... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (P... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covere... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered an... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC)... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-... A defect may cause an uncontrolled medication flow condition which may result in a dose greater t... Class I Fresenius Kabi USA, LLC
Aug 1, 2024 WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covere... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC)... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covere... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation

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.