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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DateProductReasonClassFirm
Oct 28, 2024 Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of ... Bronchoscopic visualization system power supplies have defective semiconductor components that ma... Class II Noah Medical
Oct 25, 2024 Galaxy System (GAL-001) Bronchoscopic system uninterruptable power may have defective component, may cause power supply s... Class II Noah Medical
Oct 25, 2024 Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: ... Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or eq... Class II Noah Medical
Oct 21, 2024 Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing... Due to improper labeling of products. An intended use on the label has not been reviewed and appr... Class II Karl Storz Endoscopy
Oct 11, 2024 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 2... Due to holes detected in the inner barrier system that may compromise the sterility of the affect... Class II Karl Storz Endoscopy
Oct 1, 2024 Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merl... Due to heart transmitter not being able to upgrade to the current software version in the field a... Class III Abbott Medical
Oct 1, 2024 Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is i... Due to heart transmitter not being able to upgrade to the current software version in the field a... Class III Abbott Medical
Sep 30, 2024 Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straig... Due to potential issues with design, manufacturing and documentation issues related to the valida... Class II NuVasive Specialized Orthopedics, Inc.
Sep 27, 2024 AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a batter... Values used to calibrate whole blood oximeter instruments were observed to be higher than normal,... Class II Accriva Diagnostics, Inc.
Sep 25, 2024 intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buff... Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohi... Class II Biocare Medical, LLC
Sep 23, 2024 KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40),... The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek s... Class II Pro-Dex Inc
Sep 18, 2024 Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 8090... Due to oximeters not having FDA market approval or clearance to distribute in the U.S. Class II Nihon Kohden America Inc
Sep 18, 2024 Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusabl... Due to oximeters not having FDA market approval or clearance to distribute in the U.S. Class II Nihon Kohden America Inc
Sep 17, 2024 Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a ... When PET-CT system is executing reconstruction, if PET acquisition for another patient is perform... Class II Canon Medical System, USA, INC.
Sep 6, 2024 EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor... Safety glasses with Rx indoor universal lenses fail to meet high impact safety specifications, wh... Class II Enchroma Inc
Aug 30, 2024 The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable st... Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instruct... Class II Stryker Neurovascular
Aug 26, 2024 Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model... Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slo... Class II Nova Ortho-Med Inc
Aug 26, 2024 Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/C... Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slo... Class II Nova Ortho-Med Inc
Aug 26, 2024 FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the F... Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect in... Class II Qualigen Inc
Aug 26, 2024 Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Ca... Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slo... Class II Nova Ortho-Med Inc
Aug 21, 2024 da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS50... Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomi... Class II Intuitive Surgical, Inc.
Aug 15, 2024 Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Aug 15, 2024 Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Aug 15, 2024 Alaris Pump Module Model 8100, a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Aug 15, 2024 Alaris PCA Module Model 8120, a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Aug 15, 2024 Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Aug 12, 2024 BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FA... Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube a... Class II Becton, Dickinson and Company, BD Bio Sciences
Aug 5, 2024 ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retriev... Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years inste... Class II MICROVENTION INC.
Aug 2, 2024 Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower p... Class II AURIS HEALTH INC
Aug 2, 2024 Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch ... Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower p... Class II AURIS HEALTH INC
Aug 1, 2024 Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis Sy... Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the low... Class II Outset Medical, Inc.
Jul 31, 2024 MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1... Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... Class I Medtronic MiniMed, Inc.
Jul 31, 2024 MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582,... Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... Class I Medtronic MiniMed, Inc.
Jul 31, 2024 IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM... Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU Class II Beckman Coulter Inc.
Jul 31, 2024 MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G I... Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... Class I Medtronic MiniMed, Inc.
Jul 24, 2024 Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following com... Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO Class II TMJ Solutions Inc
Jul 24, 2024 FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 ... Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously ... Class I Abbott Diabetes Care, Inc.
Jul 23, 2024 Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... Class II Karl Storz Endoscopy
Jul 23, 2024 Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... Class II Karl Storz Endoscopy
Jul 23, 2024 Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... Class II Karl Storz Endoscopy
Jul 23, 2024 Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, C... Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... Class II Karl Storz Endoscopy
Jul 23, 2024 Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... Class II Karl Storz Endoscopy
Jul 23, 2024 Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, C... Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... Class II Karl Storz Endoscopy
Jul 23, 2024 Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... Class II Karl Storz Endoscopy
Jul 23, 2024 Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... Class II Karl Storz Endoscopy
Jul 19, 2024 BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System... Software anomaly causing the skin temperature measurement accuracy to be slightly out of specific... Class II Biointellisense Inc.
Jul 19, 2024 ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ... Thrombectomy system catheter instructions for use updated to reduce adverse events due to the fol... Class I Inari Medical - Oak Canyon
Jul 17, 2024 WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-123... Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system che... Class II Boston Scientific Neuromodulation Corporation
Jul 12, 2024 Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog ... Due to mislabeling of products Class II Meddev Corp
Jul 12, 2024 Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog ... Due to mislabeling of products Class II Meddev Corp

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.