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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 | Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative m... | Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to ... | Class II | Siemens Healthcare Diagnostics, 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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.