Browse Device Recalls

603 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 603 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 603 FDA device recalls.

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DateProductReasonClassFirm
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 18, 2024 Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001... There is the potential for holes in the clear sterile barrier of the device pouch which may impac... Class II Boston Scientific Corporation
Jul 18, 2024 Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271... There is the potential for holes in the clear sterile barrier of the device pouch which may impac... Class II Boston Scientific Corporation
Jul 18, 2024 vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Mate... There is the potential for holes in the clear sterile barrier of the device pouch which may impac... Class II Boston Scientific Corporation
Jul 18, 2024 Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M00... There is the potential for holes in the clear sterile barrier of the device pouch which may impac... Class II Boston Scientific Corporation
Jul 18, 2024 VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M0012453... There is the potential for holes in the clear sterile barrier of the device pouch which may impac... Class II Boston Scientific Corporation
Jun 27, 2024 Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Sut... Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting ... Class II Boston Scientific Corporation
Jun 27, 2024 Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261,... Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting ... Class II Boston Scientific Corporation
Jun 12, 2024 Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M... Foreign material may be present on the enclosed section of the cutting wire which may lead to ina... Class II Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), RE... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H7490... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), RE... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H7... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H7... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H7490... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), RE... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H7... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H7... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), RE... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H74908... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL)... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I 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.