Browse Device Recalls

676 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 676 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 676 FDA device recalls in GA.

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Date	Product	Reason	Class	Firm
May 19, 2021	GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860	Reports received of NO measured below desired dose during transition between primary console and ...	Class I	Vero Biotech, LLC
Apr 20, 2021	Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, ...	Malware attack	Class II	Elekta, Inc.
Mar 24, 2021	Drop Arm Versamode"	The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.	Class II	Gf Health Products
Feb 18, 2021	ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedi...	Customers are being notified of results from a Toxicological Risk Assessment related to potential...	Class I	Smisson-Cartledge Biomedical, LLC
Feb 18, 2021	ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedi...	Customers are being notified of results from a Toxicological Risk Assessment related to potential...	Class I	Smisson-Cartledge Biomedical, LLC
Feb 18, 2021	ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedi...	Customers are being notified of results from a Toxicological Risk Assessment related to potential...	Class I	Smisson-Cartledge Biomedical, LLC
Feb 15, 2021	Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Pr...	The mirror may become detached and fall from the unit	Class II	CARESTREAM DENTAL, LLC
Jan 11, 2021	Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, uro...	The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.	Class II	C.R. Bard, Inc.
Nov 10, 2020	CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a ...	On November 10, 2020, it was discovered that there are post- processing microbial culture test fa...	Class II	CryoLife, Inc.
Nov 10, 2020	CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a ti...	On November 10, 2020, it was discovered that there are post- processing microbial culture test fa...	Class II	CryoLife, Inc.
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.
Jul 29, 2020	AVANOS MIC-KEY SF Gastrostomy Feeding Tube	Devices had cracked or detached from the feeding tube body	Class II	Avanos Medical, Inc.
Apr 30, 2020	Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Pro...	potential risk that Legionella may be present in the Unity machine room, specifically the heat ex...	Class II	Elekta, Inc.
Apr 15, 2020	SureStep Foley Tray System - Product Usage: Intended for use in the drainage ...	There is potential for a white paper-type residue attached to the catheter.	Class II	C.R. Bard Inc
Mar 16, 2020	CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit	The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causin...	Class II	Avanos Medical, Inc.
Jan 13, 2020	The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing s...	Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device whic...	Class II	C.R. Bard Inc
Dec 18, 2019	Elekta Unity, Image-Guided Radiation Therapy System	There have been reports of excessive heating in the MRL Gradient Connection Module.	Class II	Elekta, Inc.
Dec 11, 2019	Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 m...	103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Dia...	Class II	Brasseler USA I Lp
Nov 21, 2019	CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeS...	Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared...	Class II	Caire, Inc.
Nov 5, 2019	Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-...	Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric...	Class II	Avanos Medical, Inc.
Oct 18, 2019	BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Lengt...	One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.	Class II	Brasseler USA I Lp
Oct 18, 2019	Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" ...	Failed to meet USP minimum average value for knot pull (tensile) strength.	Class II	CP Medical Inc
Oct 8, 2019	CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG...	The connector piece to the PEG tube does not pass over the guidewire.	Class II	Avanos Medical, Inc.
Oct 8, 2019	CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG...	The connector piece to the PEG tube does not pass over the guidewire.	Class II	Avanos Medical, Inc.
Sep 16, 2019	SAROS Oxygen System Model 3000	There is an electronics control issue that causes the unit to not power on with battery power only.	Class II	Caire, Inc.
Aug 23, 2019	Monaco Radiation Treatment Planning System (RTP) System	Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setu...	Class II	Elekta, Inc.
Aug 21, 2019	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large...	Possible suture brittleness or breakage along the Envelope seam before the expiration date of the...	Class II	AZIYO BIOLOGICS
Aug 21, 2019	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEn...	Possible suture brittleness or breakage along the Envelope seam before the expiration date of the...	Class II	AZIYO BIOLOGICS
Aug 16, 2019	Irrisept Wound Debridement and Cleansing System. 12 units per case.	Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.	Class II	IrriMAX Corporation
Jul 17, 2019	Petfine Auto Injector, REF 3310VET	There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two ...	Class II	Owen Mumford USA, Inc.
Jul 17, 2019	Autoject EI, REF AJ1310	There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two ...	Class II	Owen Mumford USA, Inc.
Jun 24, 2019	Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Mag...	The QA software solution to perform the MR to MV alignment check, does not display the stored MR ...	Class II	Elekta, Inc.
Jun 19, 2019	iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2	Potential for iGUIDE to incorrectly monitor the 3D position.	Class II	Elekta, Inc.
May 23, 2019	Various products which were contract sterilized.	The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.	Class II	Anewmed Corporation
Apr 26, 2019	ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b)...	There is the potential that a HeatWrap could include cells that have a higher cell temperature th...	Class II	PF Consumer Healthcare 1 LLC
Apr 26, 2019	ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product ...	There is the potential that a HeatWrap could include cells that have a higher cell temperature th...	Class II	PF Consumer Healthcare 1 LLC
Apr 1, 2019	Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Nu...	Pin hole package failures compromising sterility of product	Class II	Dornier Medtech America, Inc.
Mar 26, 2019	EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x1...	Intermittent heat seal failures on the outer pouch of some EZ Derm products.	Class II	Molnlycke Health Care, Inc
Feb 8, 2019	Monaco Radiation Treatment Planning (RTP) System	If Improve Target Dose was chosen as an optimization model in a previous treatment session, Mon...	Class II	Elekta, Inc.
Feb 6, 2019	LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: ...	The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected thro...	Class II	LW Scientific, Inc.
Feb 6, 2019	LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: ...	The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected thro...	Class II	LW Scientific, Inc.
Feb 6, 2019	LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: u...	The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected thro...	Class II	LW Scientific, Inc.
Feb 4, 2019	Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per bo...	Potential compromise of product sterility after routine monitoring for Endotoxins showed an out o...	Class II	CP Medical Inc
Jan 30, 2019	OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore...	Product mislabeling.	Class II	Matrix Surgical Holdings, LLC
Jan 30, 2019	OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore...	Product mislabeling.	Class II	Matrix Surgical Holdings, LLC
Jan 17, 2019	On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X...	On-X Valve was mislabeled with the incorrect serial number.	Class II	CryoLife, Inc.
Dec 13, 2018	SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Produc...	potential for urine leakage around the vent on the vented sample port	Class II	Bard Medical Division
Dec 13, 2018	MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology in...	There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, whi...	Class II	Elekta, Inc.
Dec 6, 2018	BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing...	Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 c...	Class II	Bard Medical Division
Dec 4, 2018	MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology i...	If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup fi...	Class II	Elekta, 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.