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 Jul 7, 2021
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Jul 7, 2021
LeadCare II Blood Lead Test Kit Catalog Number 70-6762
High riskUsing this product could cause serious injury, illness or death — stop using it now.Magellan Diagnostics, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
FDA (openFDA device enforcement)
Reported Jul 7, 2021
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NeuMoDx Molecular Inc.
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
High riskUsing this product could cause serious injury, illness or death — stop using it now.Quidel Corporation
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remote Diagnostic Technologies Ltd.
FDA (openFDA device enforcement)
Reported Jul 7, 2021
PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spes Medica
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 7, 2021
PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spineart Sa
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Synaptive Trackable Suction Set Standard and Malleable
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synaptive Medical Inc.
FDA (openFDA device enforcement)
Reported Jun 30, 2021
Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Adler MicroMed, Inc.
FDA (openFDA device enforcement)
Reported Jun 30, 2021
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 30, 2021
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 30, 2021
FREESTYLE LANCETS 28G 100CT Item Number:2975670
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 30, 2021
Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.EHOB, Inc.
FDA (openFDA device enforcement)
Reported Jun 30, 2021
Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exact Medical Manufacturing, Inc.
17 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 30, 2021
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Jun 30, 2021
inLight Medical LED Pads used with Polychromatic light technology system
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Inlightened Partners LLC
FDA (openFDA device enforcement)
Reported Jun 30, 2021
Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Action Industries, Inc. 306
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 30, 2021
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pear Therapeutics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 30, 2021
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederlands
FDA (openFDA device enforcement)
Reported Jun 30, 2021
LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
FDA (openFDA device enforcement)
Reported Jun 30, 2021
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ventec Life Systems, Inc.
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.