Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for us... | Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead ... | Class II | Maquet Cardiovascular, LLC |
| May 17, 2024 | RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hi... | 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to jo... | Class II | Biomet, 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 | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm ... | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| 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 | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm ... | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| 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 17, 2024 | Cascade IOMAX Cortical Module, REF: 190296-200 | Electroneurodiagnostic medical device may contain a defective printed circuit board which may ca... | Class II | Cadwell Industries Inc |
| 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 | Inspire Model 3028, IV Implantable Pulse Generator | There is a potential manufacturing defect which can lead to electrical leakage in the sensing cir... | Class I | Inspire Medical Systems Inc. |
| May 16, 2024 | Philips Allura Xper FD20 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 | US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be u... | Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point ran... | Class II | Fresenius Medical Care Holdings, Inc. |
| 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 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit... | Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport m... | Class II | BioFire Diagnostics, LLC |
| 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 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 | Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000 | This recall is retroactively being reported. Refurbished bassinets failed to meet quality standar... | Class II | Happiest Baby, Inc |
| 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 |
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.