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 Feb 14, 2024
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Thoratec Corp.
FDA (openFDA device enforcement)
Reported Feb 7, 2024
MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
17 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AtriCure, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
EVair air compressor, model numbers: M1230849 and M1230847
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datex-Ohmeda, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draegerwerk Ag & Co. Kgaa
FDA (openFDA device enforcement)
Reported Feb 7, 2024
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon Endo-Surgery Inc.
FDA (openFDA device enforcement)
Reported Feb 7, 2024
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fx Shoulder
FDA (openFDA device enforcement)
Reported Feb 7, 2024
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Healthcare Austria GmbH & Co.
FDA (openFDA device enforcement)
Reported Feb 7, 2024
SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
57 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microvention Inc.
FDA (openFDA device enforcement)
Reported Feb 7, 2024
EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
11 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12…
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 Feb 7, 2024
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
11 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
smiths medical Medfusion Model 3500 Syringe pump
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terragene S.a.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.THOR Photomedicine Ltd.
FDA (openFDA device enforcement)
Reported Feb 7, 2024
Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.TriMed Inc.
FDA (openFDA device enforcement)
Reported Feb 7, 2024
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vortex Surgical Inc.
FDA (openFDA device enforcement)
Reported Feb 7, 2024
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.XTANT Medical Holdings, Inc.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Accure Laser System, Model: PFMS00004
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accure Acne, Inc.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B-K Medical A/S
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.