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
Jun 14, 2024 L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x ... Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains in... Class II Argon Medical Devices, Inc
Jun 11, 2024 Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each ... The protective pouches were identified to have been improperly labeled with UDI that is associate... Class II Medical Action Industries, Inc. 306
Jun 7, 2024 smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with B... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD Inc.
Jun 7, 2024 smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BL... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD Inc.
Jun 7, 2024 smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) ... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD Inc.
Jun 7, 2024 OMTech Desktop Laser Engraver Lack of redundant interlocks, missing required labels and certification labels as required by 21 ... Class II Rygel Advanced Machines d/b/a Omtech Laser
May 31, 2024 REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, si... Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourn... Class II Stryker Sustainability Solutions
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHE... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number S... Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... Class II Cardinal Health 200, LLC
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY ... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Cata... Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... Class II Cardinal Health 200, LLC
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY ... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEO... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NE... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY T... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED ... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRAC... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TU... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life... Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent c... Class I Baxter Healthcare Corporation
May 29, 2024 CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical proce... Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of t... Class II Integra LifeSciences Corp.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PE... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEO... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number ... Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... Class II Cardinal Health 200, LLC
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PE... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEON... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCU... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Cata... Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... Class II Cardinal Health 200, LLC
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 22, 2024 Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 21, 2024 IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO... A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO... Class II Angiodynamics, Inc.
May 17, 2024 Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278 The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... Class II B Braun Medical Inc
May 17, 2024 Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502 The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... Class II B Braun Medical Inc
May 17, 2024 Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260 The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... Class II B Braun Medical Inc
May 17, 2024 Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251. The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... Class II B Braun Medical Inc
May 17, 2024 Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Ma... Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3.... Class II Siemens Healthcare Diagnostics 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.