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.
13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.
Reported Sep 24, 2025
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Folsom Metal Products, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Max Mobility LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Information Technology, Inc.
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems (Cleveland) Inc.
FDA (openFDA device enforcement)
Reported Sep 17, 2025
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 17, 2025
Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B.Braun Medical S.A.S.
FDA (openFDA device enforcement)
Reported Sep 17, 2025
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
5 more products in this recall
FDA (openFDA device enforcement)
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)
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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.