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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.