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 |
|---|---|---|---|---|
| Apr 4, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MX... | Potential for internal fastening mechanism within generator of mobile x-Ray to fail. | Class II | Micro-X Ltd. |
| Apr 4, 2025 | KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examinat... | Potential for microbial contamination. | Class II | Klinika Mdical Gmb |
| Apr 4, 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro Supe... | Preset treatment parameters are not consistently being used in accordance with the IFU. | Class II | Olympus Corporation of the Americas |
| Apr 4, 2025 | INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation cath... | Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 3, 2025 | L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm),... | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Apr 3, 2025 | MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; | Devices for the affected lot were not assembled according to product specifications. The distrac... | Class II | Globus Medical, Inc. |
| Apr 3, 2025 | Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (... | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Apr 3, 2025 | Enhanced Verify Evaluation Handset (CFN HH90130FA) | Evaluation handsets may not be able to communicate with the neurostimulator due to handsets havin... | Class II | Medtronic Neuromodulation |
| Apr 3, 2025 | Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 8... | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Apr 3, 2025 | Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulato... | Potential for exoskeleton to lose lateral balance and cause patient to fall. | Class II | WANDERCRAFT SAS |
| Apr 3, 2025 | Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm)... | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Apr 2, 2025 | HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software ... | There is a leakage issue associated with the tubing in the manifold of the instrument. | Class II | Leica Biosystems Melbourne Pty Ltd |
| Apr 2, 2025 | Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat... | Due to manufacturing issues, abutment products were manufactured with screw seat located too high... | Class II | Preat Corp |
| Apr 2, 2025 | Washer Disinfector Aquadis 56; Model Number: 56A | The frequency inverter is not programmed by supplier according to specification which causes the ... | Class II | Getinge Disinfection Ab |
| Apr 2, 2025 | Washer Disinfector Aquadis 56; Model Number: 56M | The frequency inverter is not programmed by supplier according to specification which causes the ... | Class II | Getinge Disinfection Ab |
| Apr 1, 2025 | Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomogr... | Unintended motion issues related to Interventional Control that may lead to collision of the Gant... | Class II | Philips North America Llc |
| Apr 1, 2025 | myQA iON; Article Number: MQ10-000; | Wrong analysis results can occur if the user creates two structures with the same name, except fo... | Class II | IBA Dosimetry GmbH |
| Mar 31, 2025 | Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. St... | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead... | Class II | Belmont Instrument LLC |
| Mar 31, 2025 | Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Steri... | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead... | Class II | Belmont Instrument LLC |
| Mar 31, 2025 | Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit. | An issue with a raw material used to coat some surgical needles that may result in diminished per... | Class II | AVID Medical, Inc. |
| Mar 31, 2025 | Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparin... | Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IV... | Class II | Siemens Healthcare Diagnostics Inc |
| Mar 31, 2025 | Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, singl... | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead... | Class II | Belmont Instrument LLC |
| Mar 31, 2025 | Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit. | An issue with a raw material used to coat some surgical needles that may result in diminished per... | Class II | AVID Medical, Inc. |
| Mar 31, 2025 | Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Mod... | During routine preventative maintenance checks, it was revealed that carbon filter sensors were b... | Class II | Ultra Clean Systems, Inc. |
| Mar 31, 2025 | Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit | An issue with a raw material used to coat some surgical needles that may result in diminished per... | Class II | AVID Medical, Inc. |
| Mar 31, 2025 | 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/... | Potential crack in the female connector located on the Heat Exchanger/patient line set, which wil... | Class II | Belmont Instrument LLC |
| Mar 28, 2025 | Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S; | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the ... | Class II | Stryker GmbH |
| Mar 28, 2025 | Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S; | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the ... | Class II | Stryker GmbH |
| Mar 28, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: M... | Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load... | Class II | Micro-X Ltd. |
| Mar 28, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: M... | Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load... | Class II | Micro-X Ltd. |
| Mar 27, 2025 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer | When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information s... | Class II | Beckman Coulter, Inc. |
| Mar 27, 2025 | GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intende... | Due to a potential open seal in the sterile barrier packaging . | Class II | Galt Medical Corporation |
| Mar 27, 2025 | Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVist... | In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjun... | Class I | Bausch & Lomb Surgical, Inc. |
| Mar 27, 2025 | Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34... | Due to a potential open seal in the sterile barrier packaging. | Class II | Galt Medical Corporation |
| Mar 27, 2025 | Introducer Needle REF NDL-107-04 These needles are used for the percutane... | Due to a potential open seal in the sterile barrier packaging. | Class II | Galt Medical Corporation |
| Mar 27, 2025 | Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101... | Due to a potential open seal in the sterile barrier packaging. | Class II | Galt Medical Corporation |
| Mar 27, 2025 | Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Env... | In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjun... | Class I | Bausch & Lomb Surgical, Inc. |
| Mar 27, 2025 | B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 61280... | Due to a potential open seal in the sterile barrier packaging . | Class II | Galt Medical Corporation |
| Mar 27, 2025 | B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-0... | Due to a potential open seal in the sterile barrier packaging . | Class II | Galt Medical Corporation |
| Mar 27, 2025 | Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount | The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate... | Class II | IHB OPERATIONS B.V. |
| Mar 27, 2025 | GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutan... | Due to a potential open seal in the sterile barrier packaging. | Class II | Galt Medical Corporation |
| Mar 26, 2025 | The Trimble RTS873 robotic total station is a solution designed for construct... | An issue has been identified in the production of the RTS873 robotic total stations that may resu... | Class II | Trimble Ab |
| Mar 25, 2025 | restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: H... | The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 178... | Class II | Conformis Inc. |
| Mar 24, 2025 | IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needl... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 8... | The associated product labeling does not adequately provide compatibility information for use of ... | Class II | Zimmer, Inc. |
| Mar 24, 2025 | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 8... | The associated product labeling does not adequately provide compatibility information for use of ... | Class II | Zimmer, Inc. |
| Mar 24, 2025 | Intera CV, Model Number: 781107; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetell... | It was determined that there could be a false positive rate of up to 16.7% for the affected lots ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Mar 24, 2025 | Intera 1.0T Power/Pulsar, Model Number: 781103; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Intera 1.5T, Model Numbers: 781195 and 781295; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
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.