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 Oct 8, 2025
Biograph mMR. Model Number: 10433372.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Siemens Medical Solutions USA, Inc.
14 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2025
GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W L Gore & Associates, Inc.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
ZAP-X Radiosurgery System, Model: 300150
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zap Surgical Systems
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Oct 1, 2025
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biofire Defense
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Oct 1, 2025
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperVision, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 1, 2025
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, LLC
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 1, 2025
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mindray DS USA, Inc. dba Mindray North America
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortoma Ab
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
9 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Communications
FDA (openFDA device enforcement)
Reported Oct 1, 2025
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tandem Diabetes Care, Inc.
FDA (openFDA device enforcement)
Reported Sep 24, 2025
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
High riskUsing this product could cause serious injury, illness or death — stop using it now.3M Company
FDA (openFDA device enforcement)
Reported Sep 24, 2025
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Point Of Care Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Agilent Technologies Denmark ApS
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BigTree Sales Inc.
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Neuromodulation Corporation
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.