Browse Device Recalls

38,509 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 38,509 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 38,509 FDA device recalls.

Date	Product	Reason	Class	Firm
Nov 24, 2025	FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The F...	Due to a manufacturing process issue that may cause carbon build up in the sensor that may result...	Class I	Abbott Diabetes Care, Inc.
Nov 24, 2025	Zimmer Dermatome AN, Model/Catalog Number: 88710100	The devices may have a misaligned thickness control bar.	Class II	Zimmer Surgical Inc
Nov 24, 2025	FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeSt...	Due to a manufacturing process issue that may cause carbon build up in the sensor that may result...	Class I	Abbott Diabetes Care, Inc.
Nov 24, 2025	LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software...	Software issue only allows Concentration Limits to be defined to one digit of precision past the ...	Class II	ICU Medical, Inc.
Nov 24, 2025	Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.	A certain component of affected devices was not delivered within specification and contained impu...	Class I	Draeger, Inc.
Nov 24, 2025	Zimmer Air Dermatome, Model/Catalog Number: 00880100100	The devices may have a misaligned thickness control bar.	Class II	Zimmer Surgical Inc
Nov 24, 2025	LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Softwar...	For certain customers, the Change Summary review option ceases to operate as expected for any mig...	Class II	ICU Medical, Inc.
Nov 24, 2025	BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.	Removal of affected lot of screws due to labeling error.	Class II	Smith & Nephew, Inc.
Nov 22, 2025	Vivoo Vaginal pH Test	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025	Menopause Test Cassette (Urine)	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025	LH One Step Ovulation Test Device (Urine)	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025	Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025	Vivoo pH Test	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025	The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED ...	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025	S. Typhi/Para Typhi A Antigen	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025	LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PA...	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025	Vivoo Protein Test	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025	Exploro Highly Sensitive Male Fertility / Sperm Concentration Test	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025	Male Fertility Sperm Test for Home Use (Cassette)	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 21, 2025	The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay wit...	Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. ...	Class II	Roche Diagnostics Operations, Inc.
Nov 21, 2025	Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.	Emphasizing instructions for LVP duration programming located in the IFU.	Class II	Fresenius Kabi USA, LLC
Nov 21, 2025	Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,...	Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occur...	Class II	Medline Industries, LP
Nov 20, 2025	Restore Clinician Programmer Application (CP App), Model A71100 used with the...	Software issue where a Device Reset message displayed on the app was unable to be cleared. In rar...	Class II	Medtronic Neuromodulation
Nov 20, 2025	BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliar...	Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which ca...	Class II	CareFusion 303, Inc.
Nov 19, 2025	Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;	Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannu...	Class II	Vortex Surgical Inc.
Nov 19, 2025	AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product De...	Wire connected to the electrical box may shift out of its intended position, which may result in ...	Class II	Steris Corporation
Nov 19, 2025	AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Des...	Wire connected to the electrical box may shift out of its intended position, which may result in ...	Class II	Steris Corporation
Nov 18, 2025	Intelerad InteleShare software, with ProViewer component	Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical st...	Class II	DICOM Grid, Inc.
Nov 18, 2025	Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic...	It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro ...	Class II	AGFA Healthcare Corp.
Nov 18, 2025	Hardware configuration of the BeneVision Central Monitoring System (CMS), mar...	When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may...	Class II	Mindray DS USA, Inc. dba Mindray North America
Nov 18, 2025	HemosIL SynthAFax. Partial Thromboplastin Time Tests.	Recalled lots were manufactured with double the amount of preservative concentration.	Class III	Instrumentation Laboratory
Nov 17, 2025	Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1...	A customer experienced that during assembly and load testing of the device, the bolt for mounting...	Class II	ETAC A/S
Nov 17, 2025	Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mob...	A customer experienced that during assembly and load testing of the device, the bolt for mounting...	Class II	ETAC A/S
Nov 17, 2025	Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used...	An error event following the release of a software version for the surgical system that can resul...	Class II	Intuitive Surgical, Inc.
Nov 17, 2025	Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: ...	The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic...	Class II	SEASPINE ORTHOPEDICS CORPORATION
Nov 17, 2025	Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"...	Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may r...	Class II	Sheathing Technologies Inc
Nov 17, 2025	Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1)...	A customer experienced that during assembly and load testing of the device, the bolt for mounting...	Class II	ETAC A/S
Nov 17, 2025	The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pres...	Customer complaints of Pressio monitor rebooting.	Class II	Sophysa
Nov 17, 2025	Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mob...	A customer experienced that during assembly and load testing of the device, the bolt for mounting...	Class II	ETAC A/S
Nov 14, 2025	Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-...	Ongoing investigations identified additional instances of the device Generator remaining in a bli...	Class II	Olympus Corporation of the Americas
Nov 14, 2025	GE Healthcare Carestation anesthesia system Power Management Board (PMB) Fiel...	Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer...	Class I	GE Medical Systems China Co., Ltd.
Nov 14, 2025	Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.	Potential for incomplete seal on header bag.	Class II	AVID Medical, Inc.
Nov 14, 2025	Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse...	Ongoing investigations identified additional instances of the device Generator remaining in a bli...	Class II	Olympus Corporation of the Americas
Nov 14, 2025	GE Healthcare Carestation anesthesia system, product number and REF numbers: ...	Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer...	Class I	GE Medical Systems China Co., Ltd.
Nov 14, 2025	Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the cont...	Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious pa...	Class I	Fresenius Kabi USA, LLC
Nov 14, 2025	Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.	Potential for incomplete seal on header bag.	Class II	AVID Medical, Inc.
Nov 14, 2025	Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.	Potential for incomplete seal on header bag.	Class II	AVID Medical, Inc.
Nov 14, 2025	GE Healthcare Carestation anesthesia system, product number and REF numbers: ...	Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer...	Class I	GE Medical Systems China Co., Ltd.
Nov 14, 2025	Halyard, EP LAB PK. Catalog Number: ESJH009-03.	Potential for incomplete seal on header bag.	Class II	AVID Medical, Inc.
Nov 14, 2025	Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.	Potential for incomplete seal on header bag.	Class II	AVID Medical, 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.