Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

Clear
DateProductReasonClassFirm
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
May 17, 2024 The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the fo... Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead ... Class II Maquet Cardiovascular, LLC
May 16, 2024 Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 15, 2024 Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0... Product labels state the incorrect expiration dates that extends beyond their true expiration date Class II Cook Incorporated
May 15, 2024 Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-... Product labels state the incorrect expiration dates that extends beyond their true expiration date Class II Cook Incorporated
May 14, 2024 AMT Initial Placement Dilator Set. Used to place gastrostomy devices. Devices were labelled with the incorrect guidewire labelling. Class II Applied Medical Technology Inc
May 13, 2024 Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032 Class II Young Dental Manufacturing I, LLC
May 13, 2024 Non-sterile, single use, disposable gloves intended for medical purposes to b... Firm received complaints regarding skin irritation when using the gloves, disintegration of the g... Class II SVS LLC
May 9, 2024 Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STC... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syring... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 1... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syrin... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
Apr 24, 2024 smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Ste... Packaging contained the incorrect size of femoral head from what was displayed on the label. Class II Smith & Nephew Inc
Apr 22, 2024 Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: ... Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... Class II Wondfo USA Co Ltd
Apr 22, 2024 Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondVi... Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... Class II Wondfo USA Co Ltd
Apr 22, 2024 Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Ar... Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... Class II Wondfo USA Co Ltd
Apr 22, 2024 Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled... Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... Class II Wondfo USA Co Ltd

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.