Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
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 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 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: 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 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: 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 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 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: 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 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: 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 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 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 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 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: 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 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 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 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 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 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 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 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 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
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 GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: ... The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for ... Class II GE Healthcare (China) Co., Ltd.
Jul 12, 2024 Ion Endoluminal System, REF: 380748-65 There is a potential that the robotic system's instrument cart arm may contain screws that may ... Class II Intuitive Surgical, Inc.
Jul 11, 2024 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Produ... Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential ... Class II Medtronic Inc.
Jul 10, 2024 IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a pr... Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasi... Class II Ion Beam Applications S.A.
Jul 10, 2024 Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended f... Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within t... Class II Bard Peripheral Vascular Inc
Jul 10, 2024 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RS... Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatic... Class II Beckman Coulter, Inc.
Jul 10, 2024 DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemist... Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent r... Class II Beckman Coulter Mishima K.K.
Jul 10, 2024 The VITROS XT Chemistry Products ALB-TP Slides is a single device that contai... The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB... Class II Ortho-Clinical Diagnostics, Inc.
Jul 9, 2024 Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly IFU update to address device's battery handling information. Class II Covidien
Jul 9, 2024 DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires d... Class II Smith & Nephew, Inc.
Jul 9, 2024 DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires d... Class II Smith & Nephew, Inc.
Jul 9, 2024 BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jul 9, 2024 Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The... The weld on the light head frame can crack which could lead to problems such as the light head fr... Class II DKK Dai-Ichi Shomei Co., Ltd.
Jul 9, 2024 Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The... The weld on the light head frame can crack which could lead to problems such as the light head fr... Class II DKK Dai-Ichi Shomei Co., Ltd.
Jul 9, 2024 Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The ... The weld on the light head frame can crack which could lead to problems such as the light head fr... Class II DKK Dai-Ichi Shomei Co., Ltd.
Jul 9, 2024 BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solut... There is a potential risk that the image colony count does not adequately reflect the actual plat... Class II Becton Dickinson & Co.
Jul 9, 2024 BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jul 9, 2024 Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The ... The weld on the light head frame can crack which could lead to problems such as the light head fr... Class II DKK Dai-Ichi Shomei Co., Ltd.
Jul 9, 2024 TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV ... Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when u... Class II Integra LifeSciences Corp.
Jul 9, 2024 Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrect... Class II Medtronic Perfusion Systems
Jul 8, 2024 IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Softwar... Safety Parameters Verification Mechanisms can be deactivated in clinical runtime Class II Ion Beam Applications S.A.
Jul 8, 2024 GM60A. Digital Diagnostic Mobile X-Ray System. Potential for the anti-fall system of the device arm to fail. Class II NeuroLogica Corporation
Jul 5, 2024 Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 Product was distributed past expiration date. Class II Medtronic Xomed, Inc.
Jul 4, 2024 FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifical... Class II ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL

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.