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 Nov 29, 2023
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Convergent Dental
FDA (openFDA device enforcement)
Reported Nov 29, 2023
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 29, 2023
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leoni Cia Cable Systems
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 29, 2023
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 29, 2023
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Nov 29, 2023
DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Musculoskeletal Transplant Foundation, Inc.
FDA (openFDA device enforcement)
Reported Nov 29, 2023
Achieva 1.5T
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 29, 2023
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
FDA (openFDA device enforcement)
Reported Nov 29, 2023
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sage Products Inc.
FDA (openFDA device enforcement)
Reported Nov 29, 2023
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sentinel CH SpA
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 29, 2023
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SunMed Holdings, LLC
8 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 29, 2023
VariSoft infusion set, Model Number 1002827
High riskUsing this product could cause serious injury, illness or death — stop using it now.Unomedical A/S
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 22, 2023
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 22, 2023
AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Biomedical Division
FDA (openFDA device enforcement)
Reported Nov 22, 2023
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ion Beam Applications S.A.
FDA (openFDA device enforcement)
Reported Nov 22, 2023
ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 22, 2023
KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 22, 2023
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 22, 2023
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 22, 2023
LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, Inc.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 22, 2023
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Nov 22, 2023
Mobilett Mira wireless (VA20) mobile x-ray system(s)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research, LLC
FDA (openFDA device enforcement)
Reported Nov 15, 2023
FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
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.