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 Jan 17, 2024
VADER pedicle system, torque wrench, Catalog Number 42-702
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Icotec Ag
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Detector H. Pylori, Catalog Number IHP-30
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Immunostics, Inc.
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.mo-Vis BVBA
FDA (openFDA device enforcement)
Reported Jan 17, 2024
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
QMS Tacrolimus Calibrators, Product code 10015573
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Healthcare (Suzhou) Co., Ltd.
FDA (openFDA device enforcement)
Reported Jan 17, 2024
BrightView, Gamma Camera System, Product Code 882480.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Model No. CYF-5, Cystonephrofiberscope
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shirakawa Olympus Co., Ltd.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Sensis Vibe Hemo
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Jan 17, 2024
SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SoClean, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Townsend Design
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beaver Visitec International, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
High riskUsing this product could cause serious injury, illness or death — stop using it now.Busse Hospital Disposables, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Insulet Corporation
FDA (openFDA device enforcement)
Reported Jan 10, 2024
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Keystone Industries
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 10, 2024
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Natus Medical Incorporated
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.