Browse Device Recalls

4,545 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,545 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 4,545 FDA device recalls in CA.

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Date	Product	Reason	Class	Firm
Nov 28, 2022	Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tes...	Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emer...	Class I	Universal Meditech Inc.
Nov 21, 2022	Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the ...	An app, part of a continuous glucose monitoring system, for use with smartphone devices may autom...	Class II	Medtronic MiniMed
Nov 18, 2022	The Natus Cranial Access Kit is designed to be a complete, single use and dis...	Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical dra...	Class II	Natus Medical Incorporated
Nov 10, 2022	X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System ...	Potential that insert will be unable to disengage from the vertebral body replacement device/implant	Class II	NuVasive Inc
Nov 8, 2022	InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, ...	Diabetes management app may crash immediately upon opening, while using the app and/or while app ...	Class II	Companion Medical, Inc.
Nov 1, 2022	NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine dur...	During accelerated shelf-life extension studies it was noted that the final packaging was experie...	Class II	NuVasive Specialized Orthopedics, Inc.
Oct 21, 2022	Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, ...	Sinus Implant product label displays incorrect product information including: "Straight Delivery ...	Class II	Intersect ENT, Inc.
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 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 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	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	Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 12...	Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters...	Class II	Edwards Lifesciences, LLC
Oct 3, 2022	BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of ...	Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po...	Class II	Becton, Dickinson and Company, BD Biosciences
Oct 3, 2022	BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of ...	Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po...	Class II	Becton, Dickinson and Company, BD Biosciences
Oct 3, 2022	MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280	Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.	Class II	Beckman Coulter, Inc.
Oct 3, 2022	BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), ...	Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po...	Class II	Becton, Dickinson and Company, BD Biosciences
Sep 29, 2022	Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI...	After completion, ultrasound system's Stress Echo may not terminate if user does not manually ter...	Class II	Canon Medical System, USA, INC.
Sep 28, 2022	Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Informa...	Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notificatio...	Class II	iRhythm Technologies, Inc.
Sep 22, 2022	AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100...	Due to increase in Li-Ion Battery failures	Class II	ZOLL Circulation, Inc.
Sep 21, 2022	WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneury...	Detachment controller, of an aneurysm embolization system, has an out of specification tunnel ope...	Class II	MICROVENTION INC.
Sep 20, 2022	Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 67...	Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems...	Class II	Medtronic MiniMed
Sep 20, 2022	Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712...	Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems...	Class II	Medtronic MiniMed
Sep 20, 2022	da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devic...	Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instr...	Class II	Intuitive Surgical, Inc.
Sep 14, 2022	Disc Preparation instruments contained in the following products: CI-11050-0...	Due to manufacturing instruments which included additional features and adequate consideration wa...	Class II	Alphatec Spine, Inc.
Sep 8, 2022	Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G...	An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked...	Class II	Abbott Vascular
Sep 8, 2022	Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip N...	An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked...	Class II	Abbott Vascular
Sep 8, 2022	Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G...	An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked...	Class II	Abbott Vascular
Sep 7, 2022	Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308...	Product pouch label does not match up with carton label	Class II	BALT USA, 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.
Sep 2, 2022	Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002	COVID test kit shelf life was periodically extended, as real-time stability test timepoints passe...	Class II	LUMINOSTICS, INC dba CLIP HEALTH
Sep 1, 2022	Veritas Advanced Infusion Packs. Used in ophthalmic procedures.	As a result of returned product complaints for Veritas Phaco packs related to broken or cracked i...	Class II	Johnson & Johnson Surgical Vision, Inc.
Aug 29, 2022	OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power...	Battery may dislodge from the Power Knee	Class II	Ossur Americas
Aug 1, 2022	BD MaxGuard Extension Set, REF: ME1069	Administration set, and extension set product labels list expiration year 2027 but the labels sho...	Class II	CAREFUSION
Aug 1, 2022	BD MaxGuard Extension Set with 4-way stopcock, REF: M4058	Administration set, and extension set product labels list expiration year 2027 but the labels sho...	Class II	CAREFUSION
Aug 1, 2022	BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059	Administration set, and extension set product labels list expiration year 2027 but the labels sho...	Class II	CAREFUSION
Aug 1, 2022	6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 C...	Due to a manufacturing defect which results in a visible gap between the connector's top and bott...	Class II	ICU Medical, Inc.
Aug 1, 2022	BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: ...	Administration set, and extension set product labels list expiration year 2027 but the labels sho...	Class II	CAREFUSION
Aug 1, 2022	BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106	Administration set, and extension set product labels list expiration year 2027 but the labels sho...	Class II	CAREFUSION
Aug 1, 2022	8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Re...	Due to a manufacturing defect which results in a visible gap between the connector's top and bott...	Class II	ICU Medical, Inc.
Aug 1, 2022	The product is a handheld ultraviolet-C germicidal wand and contains two, nar...	Excessive ultraviolet-C radiation	Class II	MERCHSOURCE LLC
Aug 1, 2022	BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141	Administration set, and extension set product labels list expiration year 2027 but the labels sho...	Class II	CAREFUSION
Aug 1, 2022	BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: ...	Administration set, and extension set product labels list expiration year 2027 but the labels sho...	Class II	CAREFUSION
Aug 1, 2022	MicroClave Clear Neutral Connector. A bidirectional connector used as an acce...	Due to a manufacturing defect which results in a visible gap between the connector's top and bott...	Class II	ICU Medical, Inc.
Aug 1, 2022	6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Ch...	Due to a manufacturing defect which results in a visible gap between the connector's top and bott...	Class II	ICU Medical, Inc.
Aug 1, 2022	MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroCl...	Due to a manufacturing defect which results in a visible gap between the connector's top and bott...	Class II	ICU Medical, Inc.
Aug 1, 2022	BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433	Administration set, and extension set product labels list expiration year 2027 but the labels sho...	Class II	CAREFUSION
Aug 1, 2022	BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-por...	Administration set, and extension set product labels list expiration year 2027 but the labels sho...	Class II	CAREFUSION
Aug 1, 2022	6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spi...	Due to a manufacturing defect which results in a visible gap between the connector's top and bott...	Class II	ICU Medical, Inc.
Jul 26, 2022	Optima Coil System Model OPTI0520CSF10. For endovascular embolization.	Products were released to customers prior to the approval and release of a test report authorizin...	Class II	BALT USA, 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.