Medical device recalls
Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Sep 17, 2025
Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Contract Medical International GmbH
FDA (openFDA device enforcement)
Reported Sep 17, 2025
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Corneat Vision, Ltd.
FDA (openFDA device enforcement)
Reported Sep 17, 2025
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 17, 2025
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 /…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Sep 17, 2025
NOxBOXi Nitric Oxide Delivery System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Noxbox Ltd.
FDA (openFDA device enforcement)
Reported Sep 17, 2025
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Sep 17, 2025
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Omnia Medical
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 17, 2025
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthofix U.S. LLC
FDA (openFDA device enforcement)
Reported Sep 17, 2025
IntelliSpace Cardiovascular, Software 8.0.0.4.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.V.
FDA (openFDA device enforcement)
Reported Sep 17, 2025
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quest International, Inc.
FDA (openFDA device enforcement)
Reported Sep 17, 2025
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quidel Corporation
FDA (openFDA device enforcement)
Reported Sep 17, 2025
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Seaspine Orthopedics Corporation
FDA (openFDA device enforcement)
Reported Sep 17, 2025
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Sep 17, 2025
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Sep 17, 2025
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
FDA (openFDA device enforcement)
Reported Sep 17, 2025
Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wasatch Photonics
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bio-Rad Laboratories, Inc.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
10 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Neuromodulation Corporation
FDA (openFDA device enforcement)
Reported Sep 10, 2025
MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Caris Life Sciences
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Dexcom, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
FloPatch FP120, REF: FP120-FOT01-005
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Flosonics Medical (R/A 1929803 ONTARIO CORP.)
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical Inc.
5 more products in this recall
FDA (openFDA device enforcement)
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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.