Browse Device Recalls

2,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,276 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 2,276 FDA device recalls in 2022.

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Date	Product	Reason	Class	Firm
Oct 17, 2022	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-040...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Accelerate PhenoTest BC kit REF 10101018	Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) prob...	Class II	Accelerate Diagnostics Inc
Oct 17, 2022	GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to ...	Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller pri...	Class II	Steris Corporation
Oct 17, 2022	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN00...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IP...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly,...	The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from t...	Class I	Insulet Corporation
Oct 17, 2022	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 14, 2022	Philips Laser System, REF: LAS-100. Used in minimally invasive interventiona...	Laser System may detect Error 106 or Error 108 System Failures that will cause the system to ente...	Class II	Spectranetics Corporation
Oct 14, 2022	GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Sin...	Procedure Instruments with erroneous unit carton labels.	Class II	Sonendo Inc
Oct 14, 2022	GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02	Procedure Instruments with erroneous unit carton labels.	Class II	Sonendo Inc
Oct 14, 2022	Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10M...	Due to a defect in the outer pouch sterile seal	Class II	Medtronic Navigation, Inc.
Oct 14, 2022	Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and ...	The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a pa...	Class II	Getinge Usa Sales Inc
Oct 13, 2022	VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides F...	Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathem...	Class II	Ortho-Clinical Diagnostics, Inc.
Oct 13, 2022	EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, wh...	Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.	Class II	Boston Scientific Corporation
Oct 13, 2022	BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid iden...	Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) ...	Class II	Becton Dickinson & Co.
Oct 12, 2022	BASIN SET, MEBS42K, general surgical kit	Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the...	Class II	American Contract Systems, Inc.
Oct 12, 2022	Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101...	Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spin...	Class II	Boston Scientific Neuromodulation Corporation
Oct 12, 2022	BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (...	During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and p...	Class II	Becton Dickinson Infusion Therapy Systems Inc.
Oct 12, 2022	Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, ...	Scissors contained debris.	Class II	Medical Action Industries, Inc. 306
Oct 12, 2022	OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-...	The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.	Class II	Novapproach Spine LLC
Oct 12, 2022	Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use	Abbott has identified potential performance issues for the Alinity m System software version 1.6....	Class II	Abbott Molecular, Inc.
Oct 12, 2022	Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), ...	The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label ...	Class II	Medical Action Industries, Inc. 306
Oct 10, 2022	ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscop...	*Update12/13/22*:Product removal due to higher incidence of adverse events of foreign body re...	Class II	Boston Scientific Corporation
Oct 10, 2022	PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong ...	The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium C...	Class II	Pajunk Medical Systems, L.P.
Oct 10, 2022	ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastroi...	*Update12/13/22*:Product removal due to higher incidence of adverse events of foreign body re...	Class II	Boston Scientific Corporation
Oct 10, 2022	CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the...	Class I	Caire, Inc.
Oct 10, 2022	ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal end...	*Update12/13/22*:Product removal due to higher incidence of adverse events of foreign body re...	Class II	Boston Scientific Corporation
Oct 10, 2022	CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the...	Class I	Caire, Inc.
Oct 10, 2022	CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the...	Class I	Caire, Inc.
Oct 10, 2022	CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the...	Class I	Caire, Inc.
Oct 10, 2022	Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or ...	Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record sy...	Class II	Smiths Medical ASD Inc.
Oct 10, 2022	Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a ...	IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions f...	Class II	Hologic, Inc
Oct 7, 2022	FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V ...	Batteries could become unstable when not properly maintained and/or subjected to repeated drops, ...	Class II	Ferno-Washington Inc
Oct 7, 2022	INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi\|X REF 48...	Potential staple deployment failure and device fragment generation	Class II	Intuitive Surgical, Inc.
Oct 6, 2022	3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape	During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d...	Class II	3M Healthcare Business
Oct 6, 2022	Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP	Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters...	Class II	Edwards Lifesciences, LLC
Oct 6, 2022	3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surge...	During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d...	Class II	3M Healthcare Business
Oct 6, 2022	3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general su...	During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d...	Class II	3M Healthcare Business
Oct 6, 2022	3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general ...	During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d...	Class II	3M Healthcare Business
Oct 6, 2022	3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surger...	During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d...	Class II	3M Healthcare Business
Oct 6, 2022	3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape	During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d...	Class II	3M Healthcare Business

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.