Browse Device Recalls

4,538 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,538 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 4,538 FDA device recalls in CA.

Date	Product	Reason	Class	Firm
Oct 24, 2025	Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Numb...	As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot...	Class II	Edan Diagnostics
Oct 24, 2025	Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 ...	As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot...	Class II	Edan Diagnostics
Oct 21, 2025	CareLink Clinic, REF: MMT-7350	Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Grap...	Class II	Medtronic MiniMed, Inc.
Oct 21, 2025	VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 1071123415...	Due to an device without a premarket clearance being incorrectly package and distributed.	Class III	Accriva Diagnostics, Inc.
Oct 18, 2025	MONARCH Bronchoscope. Model Number: MBR-000211-B	Potential that product was leak tested with equipment outside of its expected operating range, re...	Class II	Auris Health, Inc
Oct 17, 2025	BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF...	If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, wh...	Class I	CareFusion 303, Inc.
Oct 16, 2025	VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.	Affected system contains components that do not meet the required distance between electrodes for...	Class II	Canon Medical System, USA, INC.
Oct 13, 2025	TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only	Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.	Class I	TMJ Solutions Inc
Oct 13, 2025	MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE a...	Due to battery component overheating while charging resulting in melting of internal components a...	Class II	MRIMed Inc.
Oct 10, 2025	CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMa...	Acute circulatory support system pump may not fit into the motor and reports received of the pump...	Class II	Thoratec LLC
Oct 9, 2025	Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA...	Due to potential corrosion issues associated with the Backup Battery cable connector that may cau...	Class II	Thoratec LLC
Oct 9, 2025	Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Ca...	Due to potential corrosion issues associated with the Backup Battery cable connector that may cau...	Class II	Thoratec LLC
Oct 9, 2025	Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) M...	Due to potential corrosion issues associated with the Backup Battery cable connector that may cau...	Class II	Thoratec LLC
Oct 9, 2025	Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Mod...	Due to potential corrosion issues associated with the Backup Battery cable connector that may cau...	Class II	Thoratec LLC
Oct 9, 2025	Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/...	Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/appro...	Class II	Myofunctional Research Company USA
Oct 6, 2025	Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are batt...	Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or ma...	Class I	Tandem Diabetes Care, Inc.
Oct 2, 2025	IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w...	IV Gravity burette administration set burette component is missing an internal shutoff valve inte...	Class I	ICU Medical, Inc.
Oct 1, 2025	Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control,...	The firm received complaints from customers reporting vial-to-vial variability when using the con...	Class II	Microgenics Corporation
Sep 30, 2025	Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 11...	Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime...	Class II	CareFusion 303, Inc.
Sep 30, 2025	All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00	Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime...	Class II	CareFusion 303, Inc.
Sep 30, 2025	Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-0...	Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime...	Class II	CareFusion 303, Inc.
Sep 30, 2025	Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139...	Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime...	Class II	CareFusion 303, Inc.
Sep 30, 2025	BD Pyxis Pro MedStation Main, REF: 1155-00	Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime...	Class II	CareFusion 303, Inc.
Sep 30, 2025	Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with...	Incorrect titanium screw, packaged with dental implant.	Class II	Prismatik Dentalcraft, Inc.
Sep 25, 2025	Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02	The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression...	Class II	DJO, LLC
Sep 25, 2025	Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast ...	Due to an identified manufacturing defect involving coating material lifting within the catheter'...	Class I	BALT USA, LLC
Sep 22, 2025	DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 T...	Due to a software error code that crashes during acquisition on patient sample when running custo...	Class II	Beckman Coulter Inc.
Sep 18, 2025	Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Cat...	Software issue for hq analyzer results in system not visibly applying appropriate flagging to res...	Class II	Abbott Laboratories
Sep 17, 2025	SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706	Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL...	Class II	Beckman Coulter Inc.
Sep 12, 2025	Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number:...	Due to Users not having access to the Instructions for Use/User Manual due to it being password p...	Class II	Noah Medical Corporation
Sep 11, 2025	BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, ...	Infusion pump module used with compatible pump infusion sets may perform outside the establishe...	Class I	CareFusion 303, Inc.
Sep 8, 2025	ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, C...	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ChemoLock Bag Spike, 01 units REF: CL-10-10	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Grad...	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoL...	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, C...	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Conne...	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLoc...	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connect...	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical ChemoLock Closed Vial Spike REF: CL-80	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical ChemoLock Bag Spike REF: CL-10	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, ...	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, 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.