Browse Device Recalls

39,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,969 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 39,969 FDA device recalls.

DateProductReasonClassFirm
Sep 25, 2023 Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lum... Channel air drying process was not validated, and that a small percentage of scopes returned to c... Class II Aizu Olympus Co., Ltd.
Sep 25, 2023 Bronchoscope-for endoscopy and endoscopic surgery within the airways and trac... Channel air drying process was not validated, and that a small percentage of scopes returned to c... Class II Aizu Olympus Co., Ltd.
Sep 25, 2023 Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. Channel air drying process was not validated, and that a small percentage of scopes returned to c... Class III Aizu Olympus Co., Ltd.
Sep 25, 2023 Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59... Premature battery depletion presents a risk that alarms will not be received by the Arial Wireles... Class II Securitas Healthcare LLC
Sep 25, 2023 Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) a... Channel air drying process was not validated, and that a small percentage of scopes returned to c... Class II Aizu Olympus Co., Ltd.
Sep 25, 2023 Tracheal fiberscope-airway management, which includes observation to access a... Channel air drying process was not validated, and that a small percentage of scopes returned to c... Class II Aizu Olympus Co., Ltd.
Sep 25, 2023 Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower dig... Channel air drying process was not validated, and that a small percentage of scopes returned to c... Class II Aizu Olympus Co., Ltd.
Sep 23, 2023 SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Refe... Due to potential air pockets between layers of material, their is the potential for complete stru... Class II Townsend Design
Sep 23, 2023 CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref ... Due to potential air pockets between layers of material, their is the potential for complete stru... Class II Townsend Design
Sep 23, 2023 SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) n... Due to potential air pockets between layers of material, their is the potential for complete stru... Class II Townsend Design
Sep 22, 2023 DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgicall... Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in ... Class II Musculoskeletal Transplant Foundation, Inc.
Sep 22, 2023 Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, dur... Class I Olympus Corporation of the Americas
Sep 21, 2023 DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and ex... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated ... Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. Class II Atrium Medical Corporation
Sep 21, 2023 EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display a... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, dis... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost C90 High Performance, used to acquire, process, store, displa... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with ... When using affected curette and software, there is a discrepancy between the actual curette tip l... Class II Acclarent, Inc.
Sep 21, 2023 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric ... Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In... Class I B. Braun Medical, Inc.
Sep 21, 2023 DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular conveni... Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Ins... Class II ROi CPS LLC
Sep 21, 2023 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In... Class I B. Braun Medical, Inc.
Sep 21, 2023 DigitalDiagnost C90 Release 3, used to acquire, process, store, display and e... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost 4 High Performance, used to acquire, process, store, display ... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display a... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 20, 2023 Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 20, 2023 Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 20, 2023 Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 20, 2023 Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 20, 2023 Monoject 20 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 20, 2023 Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 19, 2023 Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 pri... Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different... Class II Maquet Cardiovascular, LLC
Sep 19, 2023 LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test ki... During an internal audit a small percentage (<10%) of plastic caps used to close the treatment re... Class II Magellan Diagnostics, Inc.
Sep 19, 2023 NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pi... Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuat... Class II NeuroSync, Inc.
Sep 18, 2023 IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions wit... The patient positioning system can perform motions in unexpected directions, creating the potenti... Class II Ion Beam Applications S.A.
Sep 18, 2023 DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Me... Class II DeRoyal Industries Inc
Sep 18, 2023 Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS ... Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide s... Class II Atrium Medical Corporation
Sep 18, 2023 Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blo... Potential risk of reporting erroneous creatinine patient results associated with the initial star... Class II Nova Biomedical Corporation
Sep 18, 2023 Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1... Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide s... Class II Atrium Medical Corporation
Sep 18, 2023 Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain ga... Potential risk of reporting erroneous creatinine patient results associated with the initial star... Class II Nova Biomedical Corporation
Sep 18, 2023 Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE;... Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide s... Class II Atrium Medical Corporation
Sep 15, 2023 BD Alaris PCU REF 8015 Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... Class I CareFusion 303, Inc.
Sep 15, 2023 stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25m... One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured ... Class II Tornier, Inc
Sep 15, 2023 BD Alaris Syringe Module, REF 8110 Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... Class I CareFusion 303, Inc.
Sep 15, 2023 Alaris PCA Module 8120 Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... Class I CareFusion 303, Inc.
Sep 15, 2023 Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ... Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Sur... Class I Asensus Surgical Inc
Sep 14, 2023 Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW... Use of assay along with plasma specimen may result in error code which would invalidate sample. Class II Hologic, Inc.
Sep 14, 2023 Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiologica... GE HealthCare has become aware of an issue where images from two different patients may be contai... Class II GE Healthcare

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.