Browse Device Recalls

774 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 774 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 774 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jun 5, 2023	Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023	It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022...	Class II	Luminex Corporation
Jun 5, 2023	VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022	It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022...	Class II	Luminex Corporation
May 15, 2023	Philips Respironics V60 Ventilator-Intended to mechanically control or assist...	Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may po...	Class II	DRE Medical Group Inc
Mar 10, 2023	Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 175...	Sterility; Steril surgical procedure packs contain incomplete seals.	Class II	Alcon Research, LLC
Feb 1, 2023	BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Sin...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Feb 1, 2023	BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Feb 1, 2023	BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed ...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Feb 1, 2023	BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two U...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Feb 1, 2023	BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designe...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Feb 1, 2023	BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Feb 1, 2023	BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Singl...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Feb 1, 2023	BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed f...	Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo...	Class II	Becton Dickinson & Company
Nov 22, 2022	Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 78213...	Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.	Class II	Philips North America Llc
Nov 18, 2022	Cardinal Health Presource Packs IV START KIT- Intended for IV access device ...	Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i...	Class II	Cardinal Health 200, LLC
Nov 18, 2022	Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG ...	Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i...	Class II	Cardinal Health 200, LLC
Nov 18, 2022	Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device...	Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i...	Class II	Cardinal Health 200, LLC
Sep 19, 2022	125 series iGO2 Portable Oxygen Concentrator-indicated for the administratio...	An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patie...	Class II	DeVilbiss Healthcare LLC
Sep 7, 2022	THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S...	Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irr...	Class II	Johnson & Johnson Surgical Vision, Inc.
Jun 17, 2022	VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23	There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP...	Class II	Luminex Corporation
Mar 31, 2022	CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S ...	Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o...	Class II	CooperSurgical, Inc.
Mar 31, 2022	Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast me...	Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o...	Class II	CooperSurgical, Inc.
Mar 31, 2022	Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media...	Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o...	Class II	CooperSurgical, Inc.
Jan 31, 2022	Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dis...	This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of...	Class II	B. Braun Medical, Inc.
Jan 10, 2022	RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component...	The product does not have 510(k) clearance.	Class I	BASE 10 GENETICS INC
Dec 22, 2021	Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135...	Philips has identified a specific lot of non-conforming material manufactured by one of its suppl...	Class I	Philips Respironics, Inc.
Dec 22, 2021	Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The ...	Philips has identified a specific lot of non-conforming material manufactured by one of its suppl...	Class I	Philips Respironics, Inc.
Nov 2, 2021	The Steripath Gen2 Blood Collection System Model Number/Description 2700-...	Due to an uptick of complaints associated with premature needle retraction of blood collection sy...	Class II	Magnolia Medical Technologies, Inc.
Aug 11, 2021	SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems...	When using manual mode, the tabletop may not completely move in or out and result in potential de...	Class II	Philips North America Llc
Aug 11, 2021	SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical ...	When using manual mode, the tabletop may not completely move in or out and result in potential de...	Class II	Philips North America Llc
Aug 2, 2021	Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/ad...	Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).	Class II	Magnolia Medical Technologies, Inc.
Jul 21, 2021	DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use"...	There is a potential that sample carriers (w or w/o samples) within automated sampling system ma...	Class II	Beckman Coulter Inc.
Jun 14, 2021	DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Ser...	The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev...	Class I	Philips Respironics, Inc.
Jun 14, 2021	A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Conti...	The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev...	Class I	Philips Respironics, Inc.
Jun 14, 2021	SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, R...	The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev...	Class I	Philips Respironics, Inc.
Jun 14, 2021	Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Venti...	The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev...	Class I	Philips Respironics, Inc.
Jun 14, 2021	A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Suppo...	The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev...	Class I	Philips Respironics, Inc.
Jun 14, 2021	Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.	The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev...	Class I	Philips Respironics, Inc.
May 27, 2021	ARTIS pheno- angiography systems developed for single and biplane diagnostic ...	Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a ...	Class II	Siemens Medical Solutions USA, Inc
May 1, 2021	Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ...	Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni...	Class II	Philips North America Llc
May 1, 2021	Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFligh...	Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni...	Class II	Philips North America Llc
May 1, 2021	Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini ...	Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni...	Class II	Philips North America Llc
May 1, 2021	Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GX...	Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni...	Class II	Philips North America Llc
May 1, 2021	Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF ...	Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni...	Class II	Philips North America Llc
Mar 18, 2021	VERIGENE Processor SP - Product Usage: intended for processing and identifyin...	Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella sp...	Class II	Luminex Corporation
Mar 17, 2021	BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of path...	Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (exp...	Class II	Becton Dickinson & Co.
Mar 17, 2021	BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of ...	Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (exp...	Class II	Becton Dickinson & Co.
Feb 25, 2021	BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Mod...	Their is a potential that the automated staining instrument with software version 3.5.3.1 may mo...	Class II	Biocare Medical, LLC
Feb 9, 2021	Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single ...	Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta...	Class II	Cardinal Health 200, LLC
Feb 9, 2021	Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x ...	Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta...	Class II	Cardinal Health 200, LLC
Feb 9, 2021	McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen ...	Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta...	Class II	Cardinal Health 200, 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.