Browse Device Recalls
3,378 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,378 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 3,378 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Aug 1, 2024 | WALLFLEX FC ESO STENT RMV 23X105MM- 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 6.2CM IN 18.5 FR-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 23X155MM- 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 FC ESO STENT RMV 18X103MM- 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 123MM- 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 23/28MMX15CM-Wallflex Esophageal Partially Covered and... | 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 18/23-25MMX15CM- Agile 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 ESOPHAGEAL FC 23/28MMX12CM- 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 PC ESOPH STENT 23/28MM X 105MM- 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 6.2CM IN 18.5 FR- 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 18X103- 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 |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, 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.