Browse Device Recalls

34,608 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 34,608 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 34,608 FDA device recalls — Class II.

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DateProductReasonClassFirm
Feb 10, 2026 EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner ... Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on ... Class II Boston Scientific Corporation
Feb 9, 2026 RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 Due to a radiotherapy medical system software defect, when performing angular roll corrections fo... Class II Reflexion Medical, Inc.
Feb 9, 2026 Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Softw... It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to ... Class II Abbott Diagnostics Scarborough, Inc.
Feb 6, 2026 BD Kiestra" ReadA; Catalog No.: 446948. In certain situations, following a system reboot, one or more modules may have become unreachable... Class II BD KIESTRA LAB AUTOMATION
Feb 6, 2026 Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR Software anomaly in the patient positioning system may result in positional discrepancy. Class II Hitachi, Ltd. Radiation Oncology Systems, Kashi...
Feb 6, 2026 Artelon FlexBand Plus Ref: 41054 & 41057 Augmentation devices failed bacterial endotoxin testing. Class II International Life Sciences
Feb 6, 2026 Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) ... Augmentation devices failed bacterial endotoxin testing. Class II International Life Sciences
Feb 6, 2026 Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR Software anomaly in the patient positioning system may result in positional discrepancy. Class II Hitachi, Ltd. Radiation Oncology Systems, Kashi...
Feb 6, 2026 Artelon FlexBand Dynamic Matrix Ref: 31057 Augmentation devices failed bacterial endotoxin testing. Class II International Life Sciences
Feb 5, 2026 Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog N... After receiving customer complaints, investigations confirmed the presence of a positive bias in ... Class II Diagnostica Stago, Inc.
Feb 5, 2026 Campy CVA Medium 100/PK, R01272 Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lo... Class II Remel, Inc
Feb 4, 2026 The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number... Potential for the Cassette Loading Lever to break. Class II Fresenius Kabi USA, LLC
Feb 4, 2026 React Health PHOENIX 5L Oxygen Concentrator Devices which did not meet internal quality specifications were inadvertently distributed. Class II 3B Medical, Inc.
Feb 4, 2026 Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protei... The potential of out-of-range results and an underestimation of the free protein S level in norma... Class II Diagnostica Stago, Inc.
Feb 3, 2026 Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (... There is a potential issue that can lead to discordance between the simulated needle trajectory/t... Class II GE Medical Systems, LLC
Feb 3, 2026 IBA Proton Therapy System - PROTEUS 235 It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy S... Class II Ion Beam Applications S.A.
Feb 3, 2026 Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Cata... Impactor handle may be missing cross-pin Class II Exactech, Inc.
Feb 3, 2026 Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/... Impactor handle may be missing cross-pin Class II Exactech, Inc.
Feb 2, 2026 MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 A potential issue was identified with the torque strength on the external screws of the MICS3 Ang... Class II Howmedica Osteonics Corp.
Feb 2, 2026 Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Mod... The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. Class II B Braun Medical Inc
Feb 2, 2026 Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Ca... The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. Class II B Braun Medical Inc
Feb 2, 2026 Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number... The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. Class II B Braun Medical Inc
Feb 1, 2026 On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 Heart valves were released and distributed before all required testing was complete, so it cannot... Class II On-X Life Technologies, Inc.
Jan 30, 2026 Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a devi... There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... Class II GE Medical Systems, LLC
Jan 30, 2026 Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a... There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... Class II GE Medical Systems, LLC
Jan 30, 2026 Tandem pumps are battery-operated infusion pumps capable of both basal and bo... The Czech language user guide contained multiple translation errors. The most significant error ... Class II Tandem Diabetes Care, Inc.
Jan 30, 2026 MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and ... Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that ... Class II Medtronic MiniMed, Inc.
Jan 30, 2026 Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a dev... There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... Class II GE Medical Systems, LLC
Jan 30, 2026 HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: ... Due to complaints and investigations stating that alarms from the primary patient bedside monitor... Class II Covidien LLC
Jan 30, 2026 DxC 700 AU, REF: B86444, B86446 A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC instal... Class II Beckman Coulter Mishima K.K.
Jan 30, 2026 Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) ... The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and acce... Class II Medline Industries, LP
Jan 30, 2026 CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC instal... Class II Beckman Coulter Mishima K.K.
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TR... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SP... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOS... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 200... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRA... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Para... Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. Class II ReCor Medical Inc.
Jan 29, 2026 Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Para... Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. Class II ReCor Medical Inc.
Jan 29, 2026 Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per... Potential for rubber fragment detachment during use. Class II Olympus Corporation of the Americas
Jan 29, 2026 Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per ... Potential for rubber fragment detachment during use. Class II Olympus Corporation of the Americas
Jan 28, 2026 Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011. Composite polisher cups may crumble and break apart easily, which could cause a delay in patient ... Class II Ultradent Products, Inc.
Jan 28, 2026 Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,... Fabric may experience premature delamination when using included laundering instructions. Identif... Class II Medline Industries, LP
Jan 28, 2026 Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL ... Fabric may experience premature delamination when using included laundering instructions. Identif... Class II Medline Industries, LP
Jan 27, 2026 CLARITY II Laser System; Model No. 1110200210. Reports of devices sparking/popping and potentially burning patients. Class II Lutronic Corporation
Jan 27, 2026 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bu... During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch d... Class II Becton Dickinson & Company
Jan 26, 2026 Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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.