Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Clear

Date	Product	Reason	Class	Firm
Aug 21, 2018	ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indicati...	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca...	Class II	OriGen Biomedical, Inc.
Aug 21, 2018	Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, th...	There is potential for the plastic optical tip to become detached from the metal shaft.	Class II	Genicon, Inc.
Aug 21, 2018	Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, th...	There is potential for the plastic optical tip to become detached from the metal shaft.	Class II	Genicon, Inc.
Aug 21, 2018	Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinfo...	The catheter failed the endotoxin testing.	Class II	OriGen Biomedical, Inc.
Aug 21, 2018	Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, thr...	There is potential for the plastic optical tip to become detached from the metal shaft.	Class II	Genicon, Inc.
Aug 21, 2018	Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: S...	The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm di...	Class II	Exactech, Inc.
Aug 21, 2018	Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: ...	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca...	Class II	OriGen Biomedical, Inc.
Aug 21, 2018	Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula...	There is potential for the plastic optical tip to become detached from the metal shaft.	Class II	Genicon, Inc.
Aug 21, 2018	Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Pr...	There is potential for the plastic optical tip to become detached from the metal shaft.	Class II	Genicon, Inc.
Aug 21, 2018	Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, ...	There is potential for the plastic optical tip to become detached from the metal shaft.	Class II	Genicon, Inc.
Aug 21, 2018	Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) ...	There is potential for the plastic optical tip to become detached from the metal shaft.	Class II	Genicon, Inc.
Aug 21, 2018	Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinfo...	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca...	Class II	OriGen Biomedical, Inc.
Aug 21, 2018	ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catal...	ParaPost Plus Titanium Posts contain stainless steel post that are a size 4	Class II	Coltene Whaledent Inc
Aug 21, 2018	Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, th...	There is potential for the plastic optical tip to become detached from the metal shaft.	Class II	Genicon, Inc.
Aug 21, 2018	Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: ...	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca...	Class II	OriGen Biomedical, Inc.
Aug 21, 2018	Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, th...	There is potential for the plastic optical tip to become detached from the metal shaft.	Class II	Genicon, Inc.
Aug 21, 2018	Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications:...	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca...	Class II	OriGen Biomedical, Inc.
Aug 20, 2018	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy ...	Reports have been received of an anomaly that can result in a treatment without intended gating (...	Class II	Varian Medical Systems
Aug 20, 2018	ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF...	Design change implemented changing the device from a blood set with a filter to a transfer set wi...	Class II	ICU Medical, Inc.
Aug 20, 2018	fMRI Hardware System VisualSystem allows video signals from the stimulus pr...	Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the ma...	Class II	NordicNeuroLab AS
Aug 20, 2018	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The Vit...	Reports have been received of an anomaly that can result in a treatment without intended gating (...	Class II	Varian Medical Systems
Aug 17, 2018	EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28...	The firm identified the potential for a device to have an incorrect tissue gap. Use of a device w...	Class II	COVIDIEN LLC
Aug 16, 2018	BioMend Extend, REF# 0142Z, Synthetic bone grafting material.	There is a possibility that the product was packaged in the wrong box. Specifically, the product...	Class III	Collagen Matrix, Inc.
Aug 16, 2018	Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35	Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflec...	Class III	Medtronic Vascular
Aug 15, 2018	da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 ...	Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proxi...	Class II	Intuitive Surgical, Inc.
Aug 15, 2018	MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple ...	When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound T...	Class II	Agilent Technologies, Inc.
Aug 15, 2018	Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C...	This correction decision has been made because of a potential failure of one or both backrest bar...	Class II	Permobil, Ab
Aug 15, 2018	VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quan...	Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a ...	Class II	Ortho-Clinical Diagnostics
Aug 15, 2018	TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only...	The firm has become aware that the angled-hole of certain semi-tubular design bone plates may hav...	Class II	TriMed Inc.
Aug 15, 2018	VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quanti...	Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a ...	Class II	Ortho-Clinical Diagnostics
Aug 15, 2018	da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 ...	Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proxi...	Class II	Intuitive Surgical, Inc.
Aug 15, 2018	DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General ...	A supplier for the Agfa system noted a potential for the steel support cables of a similar device...	Class II	Agfa N.V.
Aug 14, 2018	APTIO CENTRIFUGE MODULE	The modules may have been shipped without a warning label for potential risk of interference to p...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018	APTIO 9000 REFRIGERATED STORAGE MODULE	The modules may have been shipped without a warning label for potential risk of interference to p...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018	Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, ...	The product may be counterfeit and could have microbial issues.	Class II	Lens.com
Aug 14, 2018	Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC...	The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact wit...	Class II	Ohio Medical Corporation
Aug 14, 2018	APTIO RACK OUTPUT MODULE	The modules may have been shipped without a warning label for potential risk of interference to p...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018	STREAMLAB - REFRIGERATED STORAGE MODULE 15000	The modules may have been shipped without a warning label for potential risk of interference to p...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018	TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklas...	The action is being initiated due to potential installation of faulty peltier-elements within the...	Class II	Tec Com Gmbh
Aug 14, 2018	STREAMLAB - REFRIGERATED STORAGE MODULE 9000	The modules may have been shipped without a warning label for potential risk of interference to p...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018	APTIO INPUT/OUTPUT MODULE	The modules may have been shipped without a warning label for potential risk of interference to p...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018	STREAMLAB CORE UNIT / LYNX WITH IOM	The modules may have been shipped without a warning label for potential risk of interference to p...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018	APTIO RACK INPUT MODULE	The modules may have been shipped without a warning label for potential risk of interference to p...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018	APTIO 15000 REFRIGERATED STORAGE MODULE	The modules may have been shipped without a warning label for potential risk of interference to p...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 13, 2018	CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538	Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi...	Class II	Custom Healthcare Systems, Inc.
Aug 13, 2018	(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-1...	Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi...	Class II	Custom Healthcare Systems, Inc.
Aug 13, 2018	CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884	Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi...	Class II	Custom Healthcare Systems, Inc.
Aug 13, 2018	CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) P...	Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi...	Class II	Custom Healthcare Systems, Inc.
Aug 13, 2018	CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 12...	Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi...	Class II	Custom Healthcare Systems, Inc.
Aug 13, 2018	remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, ...	Products have intermittently failed performance testing during stability studies with various ana...	Class II	Remel 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.