Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

Date	Product	Reason	Class	Firm
Dec 21, 2020	SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for u...	Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experi...	Class II	OMNIlife science Inc.
Dec 21, 2020	Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 ...	Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the st...	Class II	Hardy Diagnostics
Dec 21, 2020	Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber wash...	The potential that the plastic inlet hose connections may deform or break as a result of material...	Class II	Getinge Group Logistics America, LLC
Dec 18, 2020	ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuar...	CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolu...	Class II	Alung Technologies Inc
Dec 18, 2020	Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Produ...	Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user inp...	Class II	Topcon Medical Systems, Inc.
Dec 18, 2020	ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 ...	Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or A...	Class II	Siemens Medical Solutions USA, Inc
Dec 18, 2020	VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product ...	Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grai...	Class II	Smith & Nephew, Inc.
Dec 18, 2020	Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift wi...	Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, lea...	Class I	Hill-Rom, Inc.
Dec 18, 2020	AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, ...	Labeling update; To reduce the risk of false positive/false negative results the IFU for the adap...	Class II	Ansh Labs, LLC
Dec 18, 2020	Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 8811...	Component failures may cause the unit to lose all suction. Users will need to obtain alternate su...	Class II	Laerdal Medical (Suzhou) Co., Ltd.
Dec 17, 2020	A calculator/data processing module for clinical use is an electronic device ...	A software error results in the unintentional removal of the serum-indices flag that would otherw...	Class II	Roche Diagnostics Operations, Inc.
Dec 17, 2020	System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex...	GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex E...	Class II	GE Healthcare, LLC
Dec 17, 2020	EXOGEN Ultrasound Coupling Gel	Product may contain white particulates that are microbial in nature.	Class II	Bioventus, LLC
Dec 17, 2020	Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concent...	Bottles Missing Product Label	Class II	Fresenius Medical Care Holdings, Inc.
Dec 17, 2020	System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.	GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex E...	Class II	GE Healthcare, LLC
Dec 16, 2020	REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE ...	Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de...	Class II	Medtronic Neurosurgery
Dec 16, 2020	KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO ...	Contamination with S. epidermidis	Class II	Microbiologics Inc
Dec 16, 2020	Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Nu...	A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that c...	Class II	Cook Medical Llc
Dec 16, 2020	REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE ...	Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de...	Class II	Medtronic Neurosurgery
Dec 16, 2020	KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affecte...	The expiration date on the label of one component (negative control 0243U) in the set lot is inco...	Class III	Microbiologics Inc
Dec 16, 2020	REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE ...	Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de...	Class II	Medtronic Neurosurgery
Dec 16, 2020	Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G...	The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color F...	Class II	Philips Ultrasound Inc
Dec 15, 2020	Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing RE...	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun...	Class I	Penumbra Inc.
Dec 15, 2020	ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate g...	Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that d...	Class II	Boston Scientific Corporation
Dec 15, 2020	Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Devic...	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun...	Class I	Penumbra Inc.
Dec 15, 2020	WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to rel...	The connection between the massager and heat element can overheat causing smoke or spark, which m...	Class II	Wahl Clipper Corp
Dec 15, 2020	PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60P...	A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incor...	Class II	Smiths Medical ASD Inc.
Dec 15, 2020	VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentra...	Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Product...	Class II	Ortho Clinical Diagnostics Inc
Dec 15, 2020	Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056...	Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could l...	Class II	DePuy Orthopaedics, Inc.
Dec 15, 2020	Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperf...	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun...	Class I	Penumbra Inc.
Dec 15, 2020	Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing RE...	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun...	Class I	Penumbra Inc.
Dec 15, 2020	VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quanti...	Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Product...	Class II	Ortho Clinical Diagnostics Inc
Dec 14, 2020	VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL1...	Reports of the proximal end of the stent not immediately expanding upon deployment and remaining ...	Class II	Bard Peripheral Vascular Inc
Dec 14, 2020	VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10...	Reports of the proximal end of the stent not immediately expanding upon deployment and remaining ...	Class II	Bard Peripheral Vascular Inc
Dec 14, 2020	Neuroreader Medical Image Processing Software - Product Usage: intended to au...	The Neuroreader has been distributed with a reference normative database that is different from ...	Class II	Brainreader ApS
Dec 14, 2020	EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measu...	Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may ...	Class II	Phadia US Inc
Dec 14, 2020	Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use...	Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ...	Class II	Integra LifeSciences Corp.
Dec 14, 2020	VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14...	Reports of the proximal end of the stent not immediately expanding upon deployment and remaining ...	Class II	Bard Peripheral Vascular Inc
Dec 14, 2020	Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component o...	The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size ...	Class II	K2M, Inc
Dec 14, 2020	PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Nee...	There is a potential that a catheter convenience set contains a 21G access needle instead of the ...	Class II	Prytime Medical Devices, Inc.
Dec 14, 2020	Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: u...	Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ...	Class II	Integra LifeSciences Corp.
Dec 11, 2020	FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: in...	The software does not update measurements and calculations in the Clinical Reporting Application ...	Class II	Fujifilm Medical Systems U.S.A., Inc.
Dec 11, 2020	Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended f...	The electrical contactor component present in the drying chamber of the Reliance Vision Single-Ch...	Class II	Steris Corporation
Dec 11, 2020	VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction o...	VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.	Class II	Baxter Healthcare Corporation
Dec 11, 2020	VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide car...	VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interfe...	Class II	Ortho Clinical Diagnostics Inc
Dec 11, 2020	therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identif...	Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactio...	Class II	Qiagen Sciences LLC
Dec 10, 2020	TomoTherapy Treatment System - Product Usage: used as an integrated system fo...	"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.	Class II	Accuray Incorporated
Dec 10, 2020	Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334...	One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -...	Class II	Clerio Vision
Dec 10, 2020	Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S,...	Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ...	Class II	Argon Medical Devices, Inc
Dec 10, 2020	TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an i...	"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.	Class II	Accuray Incorporated

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.