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 Jan 14, 2026
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. (NeuroSciences)
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 14, 2026
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
FDA (openFDA device enforcement)
Reported Jan 14, 2026
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Meridian Bioscience Inc.
FDA (openFDA device enforcement)
Reported Jan 14, 2026
Philips Incisive CT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Healthcare (Suzhou) Co., Ltd.
FDA (openFDA device enforcement)
Reported Jan 14, 2026
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Jan 14, 2026
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remote Diagnostic Technologies Ltd.
FDA (openFDA device enforcement)
Reported Jan 14, 2026
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
FDA (openFDA device enforcement)
Reported Jan 14, 2026
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Securitas Healthcare LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 14, 2026
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Jan 14, 2026
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sophysa
FDA (openFDA device enforcement)
Reported Jan 14, 2026
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vision RT Ltd.
FDA (openFDA device enforcement)
Reported Jan 7, 2026
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beaver-Visitec International, Inc.
FDA (openFDA device enforcement)
Reported Jan 7, 2026
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ferndale Laboratories, Inc.
FDA (openFDA device enforcement)
Reported Jan 7, 2026
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, LLC
FDA (openFDA device enforcement)
Reported Jan 7, 2026
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sheathing Technologies Inc.
FDA (openFDA device enforcement)
Reported Jan 7, 2026
Material Processing Laser Products
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shenzhen Atomstack Technologies
FDA (openFDA device enforcement)
Reported Jan 7, 2026
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vortex Surgical Inc.
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AGFA Healthcare Corp.
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Alcon Research LLC
FDA (openFDA device enforcement)
Reported Dec 31, 2025
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Ireland, Inc.
FDA (openFDA device enforcement)
Reported Dec 31, 2025
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diasol, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger, Inc.
1 more product 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.