Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
Jul 16, 2024 CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also ... Damage to the battery pack may have caused a short to a capacitor within the battery pack. While... Class I Smiths Medical ASD Inc.
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Numbe... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 806583007... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Nu... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Nu... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Nu... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Nu... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Si... Failure of fusion system instruments in the field. Class II Omnia Medical
Jul 15, 2024 Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 80... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwd... Failure of fusion system instruments in the field. Class II Omnia Medical
Jul 15, 2024 Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalo... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version:... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog N... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 806... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Philips Azurion Interventional Fluoroscopic X-ray System with Software Versio... Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Numbe... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog N... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Numbe... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 12, 2024 Aespire View. This anesthesia gas machine is intended to provide general inha... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 NavaClick Syringe and Needle, Model Number LIN02 Incorrect GTIN number on carton. Class III LINEAGE BIOMEDICAL, INC
Jul 12, 2024 Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aespire 7900. This anesthesia gas machine is intended to provide general inha... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Amingo. OUS only. Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Avance. This anesthesia gas machine is intended to provide general inhalation... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
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 DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagn... Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially ... Class II Beckman Coulter, Inc.
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 Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. Th... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, 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.