Browse Device Recalls

34,180 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 34,180 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 34,180 FDA device recalls — Class II.

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DateProductReasonClassFirm
Aug 8, 2025 RayStation with the following product descriptions: 1. RayStation 11A, So... DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... Class II RAYSEARCH LABORATORIES AB
Aug 8, 2025 Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.9... Vital sign monitoring instrument may trigger an error message during blood pressures measurement... Class II Schiller, Ag
Aug 8, 2025 IntelliSpace Cardiovascular, Software 8.0.0.4. Software issue that results in the display of outdated information. Class II Philips Medical Systems Nederland B.V.
Aug 8, 2025 RayStation with the following product descriptions: 1. RayStation 8B, Sof... DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... Class II RAYSEARCH LABORATORIES AB
Aug 8, 2025 RayStation with the following product descriptions: 1. RayStation 11B, So... DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... Class II RAYSEARCH LABORATORIES AB
Aug 8, 2025 Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valve... Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-F... Class II Baxter Healthcare Corporation
Aug 6, 2025 Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, cla... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Aug 6, 2025 Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 0733294000... As a result of Post-Market half-time stability testing, false negative test result was observed f... Class II Cepheid
Aug 6, 2025 Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and ... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Aug 6, 2025 Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer.... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Aug 6, 2025 Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System Inserter, used as part of a system with an intervertebral body fusion device, may contribute to d... Class II SEASPINE ORTHOPEDICS CORPORATION
Aug 6, 2025 Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit con... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Aug 6, 2025 Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and f... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Aug 6, 2025 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. ... Reports of out-of-box failures discovered during the limited launch phase. Failure modes included... Class II Maquet Cardiovascular, LLC
Aug 6, 2025 Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer.... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Aug 5, 2025 Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H749045... The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... Class II Boston Scientific Corporation
Aug 5, 2025 Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Mod... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet ... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Aug 5, 2025 Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Numb... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Lept... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H... The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... Class II Boston Scientific Corporation
Aug 5, 2025 Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200... The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... Class II Boston Scientific Corporation
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Aug 5, 2025 Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dres... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Aug 5, 2025 Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number:... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Pinnacle Radiation Therapy Planning System: Multimodality Simulation Works... Due to a software issue, there is a potential image error of the Region of Interest for expansion... Class II Philips Medical Systems (Cleveland) Inc
Aug 5, 2025 t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology,... A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and ve... Class II Tandem Diabetes Care, Inc.
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Aug 5, 2025 Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; ... The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... Class II Boston Scientific Corporation
Aug 4, 2025 PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, ... Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, lea... Class II Merit Medical Systems, Inc.
Aug 4, 2025 Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit. Potential for open header bag seals, compromising sterility. Class II AVID Medical, Inc.
Aug 4, 2025 DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Modul... On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously w... Class II Beckman Coulter Inc.
Aug 4, 2025 Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit. Potential for open header bag seals, compromising sterility. Class II AVID Medical, Inc.
Aug 4, 2025 Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Mo... Two new potential laser safety failure modes have been identified in the product design. Overcurr... Class II WASATCH PHOTONICS
Aug 1, 2025 Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labele... Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Aug 1, 2025 Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.... Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Aug 1, 2025 Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R... Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jul 31, 2025 LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/Ti... Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security ... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 31, 2025 Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Nam... The potential of the elastic bands included in the kit detaching or fracturing during surgical pr... Class II Lumicell, Inc.
Jul 30, 2025 Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introdu... Units may have been packaged with an incorrect pouch label, which lists the reference number and ... Class II Contract Medical International GmbH
Jul 30, 2025 IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT1... Dental implants were imported under temperature and storage conditions that do not comply with th... Class II S.I.N. Implant System Ltda
Jul 30, 2025 Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Num... Due to a classification error in the inventory management system, specific medical devices were s... Class II Mckesson Medical-Surgical Inc. Corporate Office
Jul 29, 2025 Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contai... VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencin... Class II Ortho-Clinical Diagnostics, Inc.
Jul 29, 2025 VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit =... VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencin... Class II Ortho-Clinical Diagnostics, Inc.
Jul 28, 2025 PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or dif... Class II VANTIVE US HEALTHCARE LLC

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.