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 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)
Reported Jan 31, 2024
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
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 Jan 31, 2024
Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 31, 2024
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diasorin Inc.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Snapshot NIR, REF: KD204
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kent Imaging, Inc.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Model A710 Intellis Clinician Programmer Application, version 2.0.97
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Jan 31, 2024
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur H / F
FDA (openFDA device enforcement)
Reported Jan 31, 2024
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Phadia Ab
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Achieva 1.5T, Model No. 781178, 781196, 781296
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Philips North America
5 more products in this recall
FDA (openFDA device enforcement)
Free recall alerts
Get alerted about new Medical device recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.
Related categories
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.