Browse Device Recalls

35,653 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,653 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 35,653 FDA device recalls, Class II.

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DateProductReasonClassFirm
Dec 6, 2024 Portrait Core Services, a set of software services that enable the communicat... There is a software issue that can result in the loss of patient monitoring on the Portrait Centr... Class II GE Medical Systems, LLC
Dec 5, 2024 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... Class II QUIDEL ORTHO
Dec 5, 2024 LINK MP Reconstruction System Neck Segment (with suture holes, standard, unc... Error on the main label and the patient label. The labels indicate a size XXL, this is a standard... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Dec 5, 2024 Dialyzer Optiflux 160NRe Potential for internal blood leaks due to cracked polyurethane Class II Fresenius Medical Care Holdings, Inc.
Dec 5, 2024 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... Class II QUIDEL ORTHO
Dec 4, 2024 Hillrom Temperature Management Controller, MP, Model # 2083516; used in conju... Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and T... Class II Augustine Temperature Management, LLC
Dec 4, 2024 Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of... Incorrect catheter connector within the kit resulting in inability to provide a secure connection... Class II B. Braun Medical, Inc.
Dec 4, 2024 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and T... Class II Augustine Temperature Management, LLC
Dec 4, 2024 Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150M... Due to an increase in complaint that the percutaneous reference pin would not fit into the patien... Class II Medtronic Navigation, Inc.
Dec 4, 2024 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and T... Class II Augustine Temperature Management, LLC
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RET... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOO... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERIN... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" B... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG E... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK Q... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLS... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCI... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TIS... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-... Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacti... Class II Stryker Corporation
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPAT... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACT... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA N... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INF... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HE... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOC... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANE... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FR... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BON... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW300... Due to software anomalies that may impact on rod planning specifically, certain optional surgical... Class II Medicrea International
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DI... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EX... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEA... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTE... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU D... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 2, 2024 X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB611... A possible sterility issue was detected in Coloplast's facility on some Coloplast products. Class II Coloplast Manufacturing US, LLC
Dec 2, 2024 Change Healthcare Cardiology Hemo software Software defect concerning autosave mechanism may result in the clinician administering incorrect... Class II A L I Technologies Ltd
Dec 2, 2024 Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Co... Sterility assurance; microcatheter inner packaging may contain incomplete seal. Class II MICROVENTION INC.
Dec 2, 2024 VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthc... Class II Accriva Diagnostics, Inc.
Dec 2, 2024 McKesson Cardiology Hemo software Software defect concerning autosave mechanism may result in the clinician administering incorrect... Class II A L I Technologies Ltd
Dec 2, 2024 MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Impl... Knee implant may fracture due to a supplier-related issue with one component that has nonconformi... Class II Moximed, Inc.
Dec 2, 2024 Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA... A possible sterility issue was detected in Coloplast's facility on some Coloplast products. Class II Coloplast Manufacturing US, LLC
Dec 2, 2024 Change Healthcare Cardiology Hemodynamics software Software defect concerning autosave mechanism may result in the clinician administering incorrect... Class II A L I Technologies Ltd

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.