Browse Device Recalls

39,949 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,949 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 39,949 FDA device recalls.

DateProductReasonClassFirm
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Mod... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE P... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Refer to RES There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, M... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Mode... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side... A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Ma... Class II Tornier, Inc
Mar 3, 2025 Refer to RES There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK N... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE,... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PAC... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Mode... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe... Class II Baxter Healthcare Corporation
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAP... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) T A PACK, Model N... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK P... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Ca... During some clinical cases, it has been observed that the SO2 value may periodically appear as d... Class II Terumo Cardiovascular Systems Corporation
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GEN... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP P... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Ste... Five complaints received where surgeon was unable to remove and/or connect the inserter with the ... Class II ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Mo... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, M... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Mod... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, M... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Mode... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Refer to RES There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Nu... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 28, 2025 Monterey AL Implant Inserter; 22mm; Catalog 48019140. Potential for the gold unlock button to separate from the inserter. Class II Stryker Spine
Feb 28, 2025 Monterey AL Implant Inserter; 18/20mm; Catalog 48019130. Potential for the gold unlock button to separate from the inserter. Class II Stryker Spine
Feb 28, 2025 Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. Potential for the gold unlock button to separate from the inserter. Class II Stryker Spine
Feb 28, 2025 Phoroptor VRx Digital Refraction System Model Numbers: 16242 The head of the phoropter head could come loose and potentially detach due to a default in the as... Class II Reichert, Inc.
Feb 28, 2025 Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334; Multiple problems identified with the software version leading to various scanning and image issu... Class II Philips Medical Systems Nederland B.V.
Feb 28, 2025 Phoroptor VRx Digital Refraction System Model Numbers: 16241 The head of the phoropter head could come loose and potentially detach due to a default in the as... Class II Reichert, Inc.
Feb 28, 2025 Monterey AL Implant Inserter; 14/16mm; Catalog 48019120. Potential for the gold unlock button to separate from the inserter. Class II Stryker Spine
Feb 27, 2025 NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-co... The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with ... Class II Zimmer, Inc.
Feb 27, 2025 Tandem Mobi Insulin Pump with Interoperable Technology A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,... Class I Tandem Diabetes Care, Inc.
Feb 27, 2025 Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Conta... a limited number of lots were manufactured with an incorrect cylinder power. Class II CooperVision, Inc.
Feb 27, 2025 Premier Solo Diamond - Large Invented Cone; SKU: 807016C. The hardness not meeting the material specification and may cause the diamond bur to bend. Class II Premier Dental Products Co
Feb 27, 2025 FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 Increased risk of control failures and false negative test results with multiplexed nucleic acid ... Class II BioFire Diagnostics, LLC
Feb 27, 2025 Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitami... Class II Beckman Coulter, Inc.
Feb 27, 2025 t:slim X2 Insulin Pump with Interoperable Technology A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,... Class I Tandem Diabetes Care, Inc.
Feb 26, 2025 DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. ... Class II Beckman Coulter Inc.
Feb 26, 2025 Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tu... Aspiration catheter distal tip features and characteristics may not be in the scope of FDA cleara... Class I Qapel Medical 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.