Browse Device Recalls

2,049 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,049 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 2,049 FDA device recalls in N/A.

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Date	Product	Reason	Class	Firm
May 31, 2023	UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of ...	Service life of the electrical seat part drive of the treatment chair may be shortened unexpected...	Class II	UFSK - International OSYS Gmbh
May 31, 2023	Trexo Device	Electrical issues that could potentially render the device non-functional, give off electromagnet...	Class II	Trexo Robotics Holdings Inc.
May 30, 2023	REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R	Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.	Class II	Limacorporate S.p.A
May 30, 2023	GE Healthcare Vivid S60, ultrasound device	GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f...	Class II	GE Vingmed Ultrasound As
May 30, 2023	GE Healthcare Vivid S70, ultrasound device	GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f...	Class II	GE Vingmed Ultrasound As
May 30, 2023	REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R	Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.	Class II	Limacorporate S.p.A
May 30, 2023	GE Healthcare Vivid S70N, ultrasound device	GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f...	Class II	GE Vingmed Ultrasound As
May 30, 2023	GE Healthcare Vivid S60N, ultrasound device	GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f...	Class II	GE Vingmed Ultrasound As
May 24, 2023	RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a labo...	DNAs used during the manufacture of two affected models were accidentally inverted during manufac...	Class II	Cytocell Ltd.
May 24, 2023	EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In ...	Complaints that specific samples produced false positive EliA GBM results. A positive signal was ...	Class II	Phadia Ab
May 24, 2023	RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a labora...	DNAs used during the manufacture of two affected models were accidentally inverted during manufac...	Class II	Cytocell Ltd.
May 23, 2023	wDR 2.2 Mobile Digital Diagnostic X-Ray System	There is a software login in issue that may prevent the user from logging in.	Class II	SEDECAL SA
May 19, 2023	TruSignal Ear Sensor, REF TS-E-D; Oximeter	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	TruSignal Wrap Sensor, REF TS-W-D; Oximeter	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs;...	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, ...	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not ...	Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis...	Class II	Qiagen GmbH
May 19, 2023	TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for...	Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis...	Class II	Qiagen GmbH
May 19, 2023	TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; ...	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 12, 2023	Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; I...	A mechanical lock used to connect and release a locking liner into a prosthetic socket have an at...	Class II	Ossur H / F
May 9, 2023	QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and ...	If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY00...	Class II	Qiagen GmbH
May 8, 2023	Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020	Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainb...	Class II	Remote Diagnostic Technologies Ltd.
May 4, 2023	BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bon...	Drill guides might bend when axial forces are applied by surgeon during procedure and result in p...	Class II	T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023	BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fi...	Drill guides might bend when axial forces are applied by surgeon during procedure and result in p...	Class II	T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023	Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed qua...	Delay in reporting results due to Quality Controls running high outside of range. Target value an...	Class III	Randox Laboratories Ltd.
May 4, 2023	Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bon...	Drill guides might bend when axial forces are applied by surgeon during procedure and result in p...	Class II	T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023	BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fi...	Drill guides might bend when axial forces are applied by surgeon during procedure and result in p...	Class II	T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023	BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone...	Drill guides might bend when axial forces are applied by surgeon during procedure and result in p...	Class II	T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023	Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality contr...	Delay in reporting results due to Quality Controls running high outside of range. Target value a...	Class III	Randox Laboratories Ltd.
May 4, 2023	Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bon...	Drill guides might bend when axial forces are applied by surgeon during procedure and result in p...	Class II	T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 3, 2023	NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Del...	Device may experience malfunctions due to misalignment of the check valve in the manifold. If the...	Class I	NOXBOX LTD
Apr 27, 2023	Intelli-C, Right side suspended Tabletop, REF: 03400000	There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray mac...	Class II	NRT X-RAY A/S
Apr 27, 2023	Intelli-C, Left side suspended Tabletop, REF: 03400010	There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray mac...	Class II	NRT X-RAY A/S
Apr 26, 2023	HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separate...	Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cel...	Class II	HeartSine Technologies Ltd
Apr 26, 2023	MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Speci...	The wrong tibia guide was included intended for a different patient case.	Class II	Materialise N.V.
Apr 10, 2023	Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSp...	Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing ...	Class II	SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Mar 31, 2023	Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 9...	The liquid buffer component in the affected test kit lots was determined to have bacterial contam...	Class I	SD Biosensor, Inc.
Mar 28, 2023	YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR	Optical Trocars sterility assurance can not be guaranteed	Class II	Surgical Innovations Ltd
Mar 28, 2023	YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR	Optical Trocars sterility assurance can not be guaranteed	Class II	Surgical Innovations Ltd
Mar 27, 2023	TDHisto/Cyto - A software product used for managing medical information in th...	In a specific use case, when printing labels for slides, some labels may display wrong information	Class II	Technidata S.A.
Mar 24, 2023	FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685	Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,...	Class II	Richard Wolf GmbH
Mar 24, 2023	FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685	Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,...	Class II	Richard Wolf GmbH
Mar 24, 2023	FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051	Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,...	Class II	Richard Wolf GmbH
Mar 24, 2023	FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051	Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,...	Class II	Richard Wolf GmbH
Mar 21, 2023	Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2....	Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 16, 2023	JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL...	JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disas...	Class II	SPINEART SA

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.