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
Oct 16, 2020	Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, si...	Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to...	Class II	Stryker Instruments Div. of Stryker Corporation
Oct 16, 2020	Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: us...	A new inspection step was added to the cleaning and disinfection section of the Instructions For ...	Class II	Olympus Corporation of the Americas
Oct 16, 2020	Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on pat...	In-house lab observations and customer reports of overheating and/or thermal damage to the batter...	Class II	Covidien Llc
Oct 16, 2020	DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a cha...	Due to footswitch not meeting required specification for protection from ingress of solids or liq...	Class II	Ra Medical Systems, Inc.
Oct 16, 2020	Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used w...	A new inspection step was added to the cleaning and disinfection section of the Instructions For ...	Class II	Olympus Corporation of the Americas
Oct 16, 2020	Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used w...	A new inspection step was added to the cleaning and disinfection section of the Instructions For ...	Class II	Olympus Corporation of the Americas
Oct 16, 2020	Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used wit...	A new inspection step was added to the cleaning and disinfection section of the Instructions For ...	Class II	Olympus Corporation of the Americas
Oct 16, 2020	CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector	Detachment of the Male AIV Adaptor from the Y-Connector.	Class II	Avanos Medical, Inc.
Oct 16, 2020	Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: use...	A new inspection step was added to the cleaning and disinfection section of the Instructions For ...	Class II	Olympus Corporation of the Americas
Oct 16, 2020	Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: us...	A new inspection step was added to the cleaning and disinfection section of the Instructions For ...	Class II	Olympus Corporation of the Americas
Oct 16, 2020	Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: u...	A new inspection step was added to the cleaning and disinfection section of the Instructions For ...	Class II	Olympus Corporation of the Americas
Oct 14, 2020	Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous ...	5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator co...	Class II	Angiodynamics, Inc.
Oct 13, 2020	Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with a...	Luminex has determined that three (3) separate test fixtures used by field service engineers to s...	Class II	Luminex Corporation
Oct 13, 2020	Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with a...	Luminex has determined that three (3) separate test fixtures used by field service engineers to s...	Class II	Luminex Corporation
Oct 12, 2020	Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF...	There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle...	Class II	MEDTRONIC ATS MEDICAL, INC.
Oct 12, 2020	Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. ...	Labeling error, incorrect expiration date.	Class II	ROi CPS LLC
Oct 12, 2020	Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF...	There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle...	Class II	MEDTRONIC ATS MEDICAL, INC.
Oct 12, 2020	Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM...	There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle...	Class II	MEDTRONIC ATS MEDICAL, INC.
Oct 12, 2020	Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF...	There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle...	Class II	MEDTRONIC ATS MEDICAL, INC.
Oct 9, 2020	cobas infinity central lab/cobas infinity core license-The cobas infinity IT ...	Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expira...	Class II	Roche Diagnostics Operations, Inc.
Oct 9, 2020	Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling b...	Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary c...	Class III	Talladium Inc
Oct 9, 2020	Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation	The product did not receive pre-market approval or clearance.	Class II	Primus Corporation
Oct 8, 2020	Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o...	QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, b...	Class II	Microbiologics Inc
Oct 8, 2020	MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and...	Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band caus...	Class II	Medicrea International
Oct 8, 2020	Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o...	KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain t...	Class II	Microbiologics Inc
Oct 8, 2020	KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)	The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil...	Class III	Microbiologics Inc
Oct 8, 2020	Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o...	KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain t...	Class II	Microbiologics Inc
Oct 8, 2020	RayStation standalone software treatment planning system, Model No. 4.0, 4.5,...	If a region of interest (ROI) or point of interest (POI) that is referenced from an imported pla...	Class II	RAYSEARCH LABORATORIES AB
Oct 8, 2020	Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage...	Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.	Class II	Microbiologics Inc
Oct 8, 2020	InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) quali...	Product does not meet internal testing criterion; use of the product may result in a potential fa...	Class II	Enterix, Inc.
Oct 8, 2020	CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interven...	There is a potential that the cable of the Flat panel detector may break during a procedure which...	Class II	Canon Medical System, USA, INC.
Oct 7, 2020	Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid ...	Potential for cleaning solution intrusion into endoscope	Class III	Steris Corporation
Oct 6, 2020	Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjuncti...	Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS)	Class II	Arjohuntleigh Magog, Inc.
Oct 6, 2020	Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium	The product may be mislabeled.	Class II	Exactech, Inc.
Oct 6, 2020	Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium	The product may be mislabeled.	Class II	Exactech, Inc.
Oct 6, 2020	Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499	Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box...	Class III	Hardy Diagnostics
Oct 5, 2020	TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended f...	Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompressio...	Class II	Tytek Medical Inc
Oct 5, 2020	Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Sy...	Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have...	Class II	Bayer Medical Care, Inc.
Oct 5, 2020	BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a com...	Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression tha...	Class II	Becton, Dickinson and Company, BD Biosciences
Oct 5, 2020	TyTek PneumoDart- Intended for introduction into the body to facilitate remov...	Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompressio...	Class II	Tytek Medical Inc
Oct 5, 2020	EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128	The cross-reactivity of the device may present an increased level of potential false positives. S...	Class II	Thera Test Laboratories, Inc.
Oct 5, 2020	TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for i...	Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompressio...	Class II	Tytek Medical Inc
Oct 5, 2020	Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26...	FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a...	Class II	Micro-Tech Usa
Oct 1, 2020	LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49...	Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.	Class II	Microbiologics Inc
Oct 1, 2020	The Quidel Triage BNP Calibrators	Product compromised during shipment.	Class II	Medline Industries Inc
Oct 1, 2020	QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Co...	Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.	Class II	Microbiologics Inc
Oct 1, 2020	KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packa...	Potential contamination with S. epidermidis E. coli and S. warneri.	Class II	Microbiologics Inc
Oct 1, 2020	Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ75...	Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon siz...	Class II	Bard Peripheral Vascular Inc
Oct 1, 2020	EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: Thi...	The use of deionized water rather than distilled water during the manufacturing process, may have...	Class II	Epitope Diagnostics, Inc.
Sep 30, 2020	Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to mo...	The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, ...	Class II	Maquet Cardiovascular Us Sales, Llc

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.