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Browse Device Recalls

5,321 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,321 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 5,321 FDA device recalls.

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DateProductReasonClassFirm
Aug 12, 2024 Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) 7F sheath introducers labeled as 7.5F Class II Merit Medical Systems, Inc.
Aug 12, 2024 Seer Home System is an ambulatory electroencephalograph (EEG) system intended... During CAPA investigations of sight production inconsistencies, it was highlighted that previous ... Class II SEER MEDICAL PTY LTD
Aug 12, 2024 Custom Procedure Kit, REF: K12T-11077 7F sheath introducers labeled as 7.5F Class II Merit Medical Systems, Inc.
Aug 8, 2024 Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use i... Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck ... Class II Zimmer GmbH
Aug 8, 2024 eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals ... Class III T.G. Eakin Limited
Aug 8, 2024 DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, ... Material with a quality issue was used in contact lens production, so contact lenses may not meet... Class II Alcon Research LLC
Aug 8, 2024 Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in to... Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck ... Class II Zimmer GmbH
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissu... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissu... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissu... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in th... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, 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 ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retriev... Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years inste... Class II MICROVENTION 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.
Jul 31, 2024 Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway St... Labeling error with a mismatch between the shelf box serial number label and the serial number of... Class II Inspire Medical Systems Inc.
Jul 31, 2024 Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper A... Labeling error with a mismatch between the shelf box serial number label and the serial number of... Class II Inspire Medical Systems Inc.
Jul 24, 2024 (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 4... The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a r... Class II Cardinal Health 200, LLC
Jul 24, 2024 (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve,... The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a r... Class II Cardinal Health 200, LLC
Jul 12, 2024 Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog ... Due to mislabeling of products Class II Meddev Corp
Jul 12, 2024 Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog ... Due to mislabeling of products Class II Meddev Corp
Jul 9, 2024 BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jul 9, 2024 DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires d... Class II Smith & Nephew, Inc.
Jul 9, 2024 DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires d... Class II Smith & Nephew, Inc.
Jul 9, 2024 BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jul 9, 2024 Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrect... Class II Medtronic Perfusion Systems
Jul 3, 2024 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circula... Devices were labeled with an expiration date of four years and ten days rather than the validated... Class II W.L. Gore & Associates, 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.