Browse Device Recalls

2,479 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,479 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 2,479 FDA device recalls.

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DateProductReasonClassFirm
Nov 18, 2022 Cardinal Health Presource Packs IV START KIT- Intended for IV access device ... Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... Class II Cardinal Health 200, LLC
Nov 18, 2022 Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG ... Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... Class II Cardinal Health 200, LLC
Nov 18, 2022 Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device... Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... Class II Cardinal Health 200, LLC
Oct 31, 2022 Alcon Custom Pak Surgical Procedure Pack Due to difficulty removing the liner on the adhesive components of the affected drapes and as a r... Class II Alcon Research, LLC
Oct 21, 2022 Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1 Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive compon... Class II Busse Hospital Disposables, Inc.
Oct 21, 2022 Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1 Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive compon... Class II Busse Hospital Disposables, Inc.
Oct 6, 2022 3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surge... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general su... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general ... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surger... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery d... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surg... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general s... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Sep 30, 2022 CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Conv... Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 13, 2022 NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184. Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki... Class II Thor Photomedicine Ltd
Sep 13, 2022 G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177 Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki... Class II Thor Photomedicine Ltd
Sep 13, 2022 NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176 Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki... Class II Thor Photomedicine Ltd
Sep 13, 2022 NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183 Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki... Class II Thor Photomedicine Ltd
Aug 12, 2022 DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors Procedure packs contained a recalled product. Class II DeRoyal Industries Inc
Aug 1, 2022 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 C... Due to a manufacturing defect which results in a visible gap between the connector's top and bott... Class II ICU Medical, Inc.
Aug 1, 2022 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Re... Due to a manufacturing defect which results in a visible gap between the connector's top and bott... Class II ICU Medical, Inc.
Aug 1, 2022 MicroClave Clear Neutral Connector. A bidirectional connector used as an acce... Due to a manufacturing defect which results in a visible gap between the connector's top and bott... Class II ICU Medical, Inc.
Aug 1, 2022 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Ch... Due to a manufacturing defect which results in a visible gap between the connector's top and bott... Class II ICU Medical, Inc.
Aug 1, 2022 MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroCl... Due to a manufacturing defect which results in a visible gap between the connector's top and bott... Class II ICU Medical, Inc.
Aug 1, 2022 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spi... Due to a manufacturing defect which results in a visible gap between the connector's top and bott... Class II ICU Medical, Inc.
Jun 28, 2022 HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1... Battery performance issues. Battery electrical faults render it unable to power the controller, u... Class I Heartware, Inc.
Jun 27, 2022 Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock B... Ports have a potential for unintended disconnection, inability to connect to or fully engage with... Class II ICU Medical, Inc.
Jun 27, 2022 Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock ... Ports have a potential for unintended disconnection, inability to connect to or fully engage with... Class II ICU Medical, Inc.
May 25, 2022 Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C... The products may contain excess coating material on the outside and/or interior of the needle com... Class II Cook Incorporated
May 25, 2022 Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug ... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 5, 2022 HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular As... Batteries for the HVAD system have a weld defect affecting internal components within the HVAD ba... Class I Medtronic Inc
Mar 30, 2022 Instructions for Use, Patient Manuals, and Emergency Responder Guides for Hea... Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Respo... Class II Medtronic Inc
Mar 30, 2022 HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Nu... Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... Class II Heartware, Inc.
Mar 30, 2022 HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HV... Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... Class II Heartware, Inc.
Mar 30, 2022 HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 14... Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... Class II Heartware, Inc.
Mar 30, 2022 HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420 Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... Class II Heartware, Inc.
Mar 30, 2022 HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONIT... Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... Class II Heartware, Inc.
Mar 30, 2022 HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 14... Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... Class II Heartware, Inc.
Mar 1, 2022 Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05... A design change made to a hemostasis valve to improve manufacturability caused an internal gap be... Class II Merit Medical Systems, 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.