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.

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Date	Product	Reason	Class	Firm
Jul 21, 2020	Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI:...	The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may...	Class II	Neurovision Medical Products Inc
Jul 21, 2020	Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKI...	The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may...	Class II	Neurovision Medical Products Inc
Jul 20, 2020	BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-0...	BD is experiencing elevated rates of potential false positive results from certain customers when...	Class II	Becton Dickinson & Co.
Jul 20, 2020	Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic ...	Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0...	Class II	Conformis, Inc.
Jul 20, 2020	NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Us...	Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant me...	Class II	NOBEL BIOCARE SERVICES AG
Jul 20, 2020	VITROS XT3400 Chemistry System, Product code 6844458	When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. A...	Class II	Ortho Clinical Diagnostics
Jul 20, 2020	VITROS XT7600 Integrated System, Product code 6844461	When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. A...	Class II	Ortho Clinical Diagnostics
Jul 17, 2020	VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6...	The reagent bottles may be swapped within the reagent pack, which may lead to false negative resu...	Class II	Ortho Clinical Diagnostics
Jul 17, 2020	Match Point System The Match Point System is intended to by uses as a surg...	The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly i...	Class II	Materialise N.V.
Jul 17, 2020	Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal p...	A low risk of a false positive result being issued with a laboratory developed test (LDT) that ut...	Class II	Cytocell Ltd.
Jul 17, 2020	VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog numbe...	The reagent bottles may be swapped within the reagent pack, which may lead to false negative resu...	Class II	Ortho Clinical Diagnostics
Jul 17, 2020	Restore Clinician Programmer Application Software, model number A71100, used...	The original version of the A71100 Restore Clinician Programmer Application has been identified t...	Class II	Medtronic Neuromodulation
Jul 17, 2020	Parvovirus B19 IgG EIA kit Part No. V519IGUS	Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value	Class II	Diasorin Inc.
Jul 17, 2020	Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Pl...	IBA became aware of an issue to resume aborted irradiations because the plan to complete the trea...	Class II	Ion Beam Applications S.A.
Jul 16, 2020	Tibial knee prosthesis	Due to an inconsistency in the raw material process, specific lots may contain units with interna...	Class II	Smith & Nephew, Inc.
Jul 16, 2020	uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is inte...	1) Service function problem may cause false marking of a bad channel resulting in ring artifacts;...	Class II	Shanghai United Imaging Healthcare Co., Ltd.
Jul 16, 2020	Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usag...	Incorrect expiration date included in test kit labeling and/or in Substrate component label.	Class III	Oxford Immunotec
Jul 16, 2020	Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usag...	Incorrect expiration date included in test kit labeling and/or in Substrate component label.	Class III	Oxford Immunotec
Jul 16, 2020	Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M35...	The therapy switch may fail, resulting in the device exhibiting the following behaviors: the devi...	Class II	Philips North America, LLC
Jul 16, 2020	uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is in...	1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Poten...	Class II	Shanghai United Imaging Healthcare Co., Ltd.
Jul 16, 2020	BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; ...	Incorrect manufacturer calibration	Class II	Brainlab AG
Jul 16, 2020	BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 U...	Incorrect manufacturer calibration	Class II	Brainlab AG
Jul 15, 2020	CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: ind...	Unit boxes not properly sealed	Class III	OraSure Technologies, Inc.
Jul 15, 2020	Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product...	Unit boxes not properly sealed	Class III	OraSure Technologies, Inc.
Jul 15, 2020	Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 100...	Unit boxes not properly sealed	Class III	OraSure Technologies, Inc.
Jul 15, 2020	StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product...	The product contains a non-functional component not referenced in product labeling.	Class II	Stimwave Technologies Inc
Jul 15, 2020	The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by pat...	As a result of the release of new software version to CareLink Personal website, the IOS app for ...	Class II	Medtronic Inc.
Jul 15, 2020	StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and...	The product contains a non-functional component not referenced in product labeling.	Class II	Stimwave Technologies Inc
Jul 15, 2020	OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems wi...	There are potential issues related to the operational state of the scanner, specifically for tran...	Class II	NeuroLogica Corporation
Jul 15, 2020	StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2....	The product contains a non-functional component not referenced in product labeling.	Class II	Stimwave Technologies Inc
Jul 15, 2020	QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - P...	There is an increased rate of potential false positive results for the Influenza A (no subtype) t...	Class II	Qiagen Sciences LLC
Jul 15, 2020	SICAT IMPLANT V2.0	A dentist found implant positions are not correctly exported from the implant planning software S...	Class II	SICAT GMBH & CO. KG
Jul 15, 2020	StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and...	The product contains a non-functional component not referenced in product labeling.	Class II	Stimwave Technologies Inc
Jul 15, 2020	SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, L...	US-dates between the product package label and the bar code display.	Class II	Hager & Meisinger Gmbh
Jul 15, 2020	StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product...	The product contains a non-functional component not referenced in product labeling.	Class II	Stimwave Technologies Inc
Jul 15, 2020	StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Produc...	The product contains a non-functional component not referenced in product labeling.	Class II	Stimwave Technologies Inc
Jul 14, 2020	CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocesso...	The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an ...	Class II	GE Healthcare, LLC
Jul 14, 2020	CADD Administration Sets, Model #21-7346-24	Product may have been manufactured with an air filter assembled in an incorrect orientation.	Class II	Smiths Medical ASD Inc.
Jul 14, 2020	Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement ...	Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143...	Class II	Olympus Corporation of the Americas
Jul 14, 2020	FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212...	When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tub...	Class II	Inpeco S.A.
Jul 14, 2020	Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Pati...	The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discr...	Class II	Thomas Scientific
Jul 14, 2020	Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cio...	Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D...	Class II	Siemens Medical Solutions USA, Inc
Jul 14, 2020	Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) Th...	When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tub...	Class II	Inpeco S.A.
Jul 14, 2020	Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement...	Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143...	Class II	Olympus Corporation of the Americas
Jul 14, 2020	Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX...	When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tub...	Class II	Inpeco S.A.
Jul 13, 2020	ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R	Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle...	Class II	Aesculap Implant Systems LLC
Jul 13, 2020	Medtronic SynchroMed, Model A10	The previous software application version (1.1.300) is missing a decimal separator (a comma) for ...	Class II	Medtronic Inc.
Jul 13, 2020	Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate ...	Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included ...	Class III	OraSure Technologies, Inc.
Jul 13, 2020	VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS ...	Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS...	Class II	Ortho-Clinical Diagnostics
Jul 13, 2020	VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic q...	Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS...	Class II	Ortho-Clinical Diagnostics

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.