Browse Device Recalls

206 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 206 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 206 FDA device recalls in 2026.

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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 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 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
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 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Feb 6, 2026 Artelon FlexBand Dynamic Matrix Ref: 31057 Augmentation devices failed bacterial endotoxin testing. Class II International Life Sciences
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, 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 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 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 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
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 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 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 27, 2026 Impella RP. Product Code: 0046-0011. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... Class I Abiomed, Inc.
Jan 27, 2026 Impella RP with SmartAssist. Product Code: 0046-0035. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... Class I Abiomed, Inc.
Jan 27, 2026 Impella RP Flex with SmartAssist. Product Code: 1000323. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... Class I Abiomed, Inc.
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.
Jan 26, 2026 Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Softwa... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Sof... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)7... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version ... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Soft... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)7222... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Softwa... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 23, 2026 CS100 IABP. Software Version CS100 IABP Q.01. The firm has identified that the battery runtime and cycle specifications contained in the device... Class II Datascope Corp.
Jan 23, 2026 CS300 IABP. Software Version CS300 IABP C.01. The firm has identified that the battery runtime and cycle specifications contained in the device... Class II Datascope Corp.
Jan 21, 2026 Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt sup... Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Li... Class II Agiliti Health - Ellis
Jan 21, 2026 MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm... Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnet... Class II Stryker Corporation
Jan 21, 2026 PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog ... Due to pediatric defibrillator electrode delamination Class II Physio-Control, Inc.
Jan 21, 2026 EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism wer... Class II Staar Surgical AG
Jan 21, 2026 MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-0... Device for bronchoscopic visualization, patient airway access has software issue: if application ... Class II Auris Health, Inc
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055407504. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000; Part No. 00055445010 & 00055445011. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055415004. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055360010. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory

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.