Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
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 Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY Deep brain stimulation system will first turn off after approximately 50 days after the system is... 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 TourniKwik Tourniquet Set (CFN 79012) Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set. Class II Medtronic Perfusion Systems
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 Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model ... When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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 Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: ... When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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 KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
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 HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 A610 Clinician Programmer (CP) Software Application (app) with the following ... Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI ... Class II Medtronic Neuromodulation
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 15, 2024 KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 Ventilator HAMILTON-C6, PN: 160021 Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnec... Class I Hamilton Medical AG
May 15, 2024 LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: ... Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 KNEE SCOPE Procedure tray Catalog Number: COKN48L Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 HAND PACK-Procedure Kit Catalog Number: WEHD16C Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract 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.