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
Jan 21, 2026	MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm...	Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnet...	Class II	Stryker Corporation
Jan 21, 2026	MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-0...	Device for bronchoscopic visualization, patient airway access has software issue: if application ...	Class II	Auris Health, Inc
Jan 2, 2026	ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 26...	Due a design issue where the navigated array connection geometry is incorrect.	Class II	Alphatec Spine, Inc.
Jan 2, 2026	ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 26...	Due a design issue where the navigated array connection geometry is incorrect.	Class II	Alphatec Spine, Inc.
Dec 30, 2025	da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Nu...	Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may resu...	Class II	Intuitive Surgical, Inc.
Dec 19, 2025	Alphenix INFX-8000C, interventional fluoroscopic x-ray system	It has been discovered that there is a possibility that the fixing screws of the ceiling movement...	Class II	Canon Medical System, USA, INC.
Dec 19, 2025	Alphenix INFX-8000V, interventional fluoroscopic x-ray system	It has been discovered that there is a possibility that the fixing screws of the ceiling movement...	Class II	Canon Medical System, USA, INC.
Dec 19, 2025	Alphenix INFX-8000H, interventional fluoroscopic x-ray system	It has been discovered that there is a possibility that the fixing screws of the ceiling movement...	Class II	Canon Medical System, USA, INC.
Dec 19, 2025	VANTAGE TITAN 3T Model MRT-3010/MEXL-3010	There is a potential for formation of ice occurring in the venting system of the superconducting ...	Class II	Canon Medical System, USA, INC.
Dec 19, 2025	Alphenix INFX-8000F, interventional fluoroscopic x-ray system	It has been discovered that there is a possibility that the fixing screws of the ceiling movement...	Class II	Canon Medical System, USA, INC.
Dec 19, 2025	Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: R...	Needle free access device intended as accessory to vascular access used in hemodialysis or access...	Class II	ICU Medical, Inc.
Dec 19, 2025	VANTAGE GALAN 3T Model MRT-3020/MEXL-3020	There is a potential for formation of ice occurring in the venting system of the superconducting ...	Class II	Canon Medical System, USA, INC.
Dec 15, 2025	da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 ...	Access Port System tray may develop cracks potentially resulting in a sterility breach.	Class II	Intuitive Surgical, Inc.
Dec 11, 2025	Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23	There is the potential for extended length of the blade obturator after assembly into the cannula...	Class II	Applied Medical Resources Corp
Dec 5, 2025	Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Numbe...	Incorrect expiration date	Class II	LimFlow, Inc.
Dec 4, 2025	Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model...	Due to probe bags that may have a compromised or incomplete sterile pouch seal.	Class II	Intuitive Surgical, Inc.
Dec 3, 2025	BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 1...	Due a software issue that may result in equipment not receiving timely updates of patient, medica...	Class II	CareFusion 303, Inc.
Nov 27, 2025	Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Pr...	Behind-the-ear sound processer packaging label is different then included product.	Class II	Advanced Bionics, LLC
Nov 24, 2025	FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The F...	Due to a manufacturing process issue that may cause carbon build up in the sensor that may result...	Class I	Abbott Diabetes Care, Inc.
Nov 24, 2025	FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The F...	Due to a manufacturing process issue that may cause carbon build up in the sensor that may result...	Class I	Abbott Diabetes Care, Inc.
Nov 24, 2025	FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The F...	Due to a manufacturing process issue that may cause carbon build up in the sensor that may result...	Class I	Abbott Diabetes Care, Inc.
Nov 24, 2025	FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeSt...	Due to a manufacturing process issue that may cause carbon build up in the sensor that may result...	Class I	Abbott Diabetes Care, Inc.
Nov 20, 2025	BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliar...	Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which ca...	Class II	CareFusion 303, Inc.
Nov 17, 2025	Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used...	An error event following the release of a software version for the surgical system that can resul...	Class II	Intuitive Surgical, Inc.
Nov 17, 2025	Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: ...	The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic...	Class II	SEASPINE ORTHOPEDICS CORPORATION
Nov 17, 2025	Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"...	Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may r...	Class II	Sheathing Technologies Inc
Nov 13, 2025	InPen App, Model/CFN Number: MMT-8061 (Android Users)	When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification St...	Class II	Medtronic MiniMed, Inc.
Nov 7, 2025	Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vin...	Due to a software implementation error that allowed instruments arms failing an important diagnos...	Class II	Intuitive Surgical, Inc.
Nov 6, 2025	BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD Alar...	Due to a number of modules flashed with a date and time associated with the daylight savings time...	Class II	CareFusion 303, Inc.
Nov 5, 2025	Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be ...	Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign obje...	Class II	Accriva Diagnostics, Inc.
Nov 5, 2025	Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.	Product testing did not meet expected stability criteria.	Class II	Cepheid
Nov 3, 2025	SQ40S Blood Transfusion Filter	Due to products being released for distribution prior to completion of the required quality contr...	Class II	GVS TM, Inc
Nov 2, 2025	MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software...	A software timing and processor communication issue in MiniMed" 780G software version 6.60 may tr...	Class II	Medtronic MiniMed, Inc.
Oct 30, 2025	Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10	Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 ce...	Class II	Cepheid
Oct 30, 2025	Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10	Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 ce...	Class II	Cepheid
Oct 28, 2025	Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: ...	An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with ...	Class II	Illumina, Inc.
Oct 24, 2025	Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 ...	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: Patient Monitor Model/Catalog Number: iM50, ...	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 & Maternal Monitor Model/Catalog Numbe...	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: Patient Monitor Model/Catalog Number: X8, X1...	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: 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: Vital Signs Monitor Model/Catalog Number: iM...	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: Vital Signs Monitor Model/Catalog Number: iM...	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: Vital Signs Monitor Model/Catalog Number: M3...	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: Vital Signs Monitor Model/Catalog Number: M3...	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: Vital Signs Monitor Model/Catalog Number: M3...	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: Patient Monitor Model/Catalog Number: iM8, i...	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: Patient Monitor Model/Catalog Number: elite ...	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: Patient Monitor Model/Catalog Number: iX10, ...	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: Telemetry Transmitter Model/Catalog Number: ...	As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot...	Class II	Edan Diagnostics

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.