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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.