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 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)
Reported Sep 10, 2025
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. (NeuroSciences)
7 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lumicell, Inc.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Medshape Universal Joints, REF: DNE-9000-UJ
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medshape, Inc.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Micro Joystick R-net. Electrical wheelchair component.
High riskUsing this product could cause serious injury, illness or death — stop using it now.mo-Vis BVBA
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Moderate riskThis product could cause temporary or reversible health problems — stop using it.O&m Halyard Inc.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preat Corp.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Premia Spine Ltd.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
8 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.