Browse Device Recalls

2,601 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,601 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 2,601 FDA device recalls in 2023.

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Date	Product	Reason	Class	Firm
Oct 6, 2023	ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robot...	Users of the patient positioning system ORION System can be faced with a sudden short-term accele...	Class II	LEONI CIA CABLE SYSTEMS
Oct 6, 2023	D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.	Customer complaint received that reported the applier failed during surgery. The applier did not ...	Class II	Peter Lazic Gmbh
Oct 6, 2023	Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm	There is the potential for the needle drive to become dislodged and/or broken which could result ...	Class II	Intuitive Surgical, Inc.
Oct 5, 2023	REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2	Mislabeling	Class II	Encore Medical, LP
Oct 5, 2023	CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with...	Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to incl...	Class I	Integra LifeSciences Corp.
Oct 5, 2023	Mobilett Mira wireless (VA20) mobile x-ray system(s)	Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray a...	Class II	Siemens Medical Solutions USA, Inc
Oct 5, 2023	Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32...	Mislabeling	Class II	Encore Medical, LP
Oct 5, 2023	MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00;...	If "Clear All" selected medications is selected on patient profile, the automated dispensing cabi...	Class II	CareFusion 303, Inc.
Oct 4, 2023	Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing devic...	Due to products distributed without premarket clearance or approvals.	Class II	Visgeneer, Inc.
Oct 4, 2023	Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R...	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with...	Class II	Edwards Lifesciences, LLC
Oct 4, 2023	VERIQUICK PREGNANCY TEST 1CT, SKU 901260	Products were stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
Oct 4, 2023	FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx...	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with...	Class II	Edwards Lifesciences, LLC
Oct 4, 2023	Integris-Allura IGTS Fixed Systems	Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy...	Class II	Philips North America
Oct 4, 2023	TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 ...	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with...	Class II	Edwards Lifesciences, LLC
Oct 4, 2023	FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx...	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with...	Class II	Edwards Lifesciences, LLC
Oct 4, 2023	TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60...	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with...	Class II	Edwards Lifesciences, LLC
Oct 4, 2023	Azurion IGTS Fixed Systems	Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy...	Class II	Philips North America
Oct 4, 2023	Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx on...	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with...	Class II	Edwards Lifesciences, LLC
Oct 4, 2023	ORAL B MOUTH SORE RINSE 237ML, SKU 999087	Products were stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
Oct 4, 2023	FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU ...	Products were stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
Oct 4, 2023	AT HOME MARIJUANA TEST STRIP, SKU 900752	Products were stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
Oct 4, 2023	Zenition 50 & 70 Mobile Surgery C-arm	Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy...	Class II	Philips North America
Oct 4, 2023	CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used fo...	Potential for damaged and frayed power connector plug with repeated bending or manipulation beyon...	Class II	St. Jude Medical
Oct 4, 2023	GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN ...	Products were stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
Oct 4, 2023	BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20G...	Over-the-needle, intravascular catheters may have needles that do not retract properly into the b...	Class II	Becton Dickinson Infusion Therapy Systems Inc.
Oct 4, 2023	HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000...	Progressa+ beds have the potential for static buildup from the casters and/or power drive. This s...	Class II	Baxter Healthcare Corporation
Oct 4, 2023	CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260	Products were stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
Oct 4, 2023	Veradius Unity Mobile Surgery C-arm	Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy...	Class II	Philips North America
Oct 4, 2023	ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950	Products were stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
Oct 4, 2023	BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surge...	Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy...	Class II	Philips North America
Oct 4, 2023	FIRST RESPONSE 2 CT, SKU 902343	Products were stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
Oct 4, 2023	Allura Xper IGTS Fixed Systems	Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy...	Class II	Philips North America
Oct 4, 2023	DENTEMP ONE STEP .077OZ, SKU 902139	Products were stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
Oct 4, 2023	Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing devic...	Due to products distributed without premarket clearance or approvals.	Class II	Visgeneer, Inc.
Oct 4, 2023	MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935	Products were stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
Oct 3, 2023	Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay,...	Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma sa...	Class II	Roche Diagnostics Operations, Inc.
Oct 2, 2023	Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL...	Due to product outer packaging incorrectly labeled.	Class II	Edge Biologicals Inc
Oct 2, 2023	Coapt ControlSeal Electrode, cutaneous EMG Electrode	Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or wa...	Class II	Coapt LLC
Oct 2, 2023	ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite Sy...	Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.	Class II	Olympus Corporation of the Americas
Oct 2, 2023	STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vit...	Deterioration in the stability of the Test Strips results in diminished low-range detection capab...	Class II	Stanbio Laboratory, LP
Oct 2, 2023	The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system ut...	There is a potential for unexpected failure of the electrical components within the Carestream He...	Class II	Carestream Health, Inc.
Oct 2, 2023	DRX Revolution Mobile X-Ray System	Unexpected failure of electrical components within the CPI generator.	Class II	Carestream Health, Inc.
Oct 2, 2023	Coapt Dome Electrode, Gen2 system, cutaneous electrode	Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or wa...	Class II	Coapt LLC
Oct 2, 2023	EVIS EXERA III Gastrointestinal Videoscope	Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of dry...	Class II	Olympus Corporation of the Americas
Sep 29, 2023	EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocu...	Their is a potential that intraocular implant devices may not meet specifications.	Class II	Staar Surgical Company
Sep 29, 2023	GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate...	Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (...	Class II	Instrumentation Laboratory
Sep 29, 2023	Alinity c Iron Reagent, Reference Number 08P3920	A high recovery of Iron assay has been observed at some customer sites. Internal studies confirm...	Class II	Sentinel CH SpA
Sep 29, 2023	LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020	Their is a potential for battery pins to become loose within the defibrillator resulting in power...	Class II	Physio-Control, Inc.
Sep 29, 2023	LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023	Their is a potential for battery pins to become loose within the defibrillator resulting in power...	Class II	Physio-Control, Inc.
Sep 29, 2023	EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraoc...	Their is a potential that intraocular implant devices may not meet specifications.	Class II	Staar Surgical Company

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.