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 Jun 16, 2021
COVID-19 Self-Test Kit *** INNOVA *** 7T
High riskUsing this product could cause serious injury, illness or death — stop using it now.Innova Medical Group, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 16, 2021
Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 16, 2021
Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA, Inc.
FDA (openFDA device enforcement)
Reported Jun 16, 2021
VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Microvention Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 16, 2021
NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nico Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 16, 2021
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Normand-Info S.A.S.U.
FDA (openFDA device enforcement)
Reported Jun 16, 2021
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 16, 2021
Olympus Sterile Optical Laser Fiber, single use and reusable
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quanta System, S.p.A.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 16, 2021
RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 ,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
FDA (openFDA device enforcement)
Reported Jun 16, 2021
JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
FDA (openFDA device enforcement)
Reported Jun 16, 2021
SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sunstar Americas, Inc.
FDA (openFDA device enforcement)
Reported Jun 16, 2021
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Viewray, Inc.
FDA (openFDA device enforcement)
Reported Jun 16, 2021
WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wishbone Medical, Inc.
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Clinical Laserthermia Systems Ab
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta, Inc.
FDA (openFDA device enforcement)
Reported Jun 9, 2021
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Flower Orthopedics Corporation
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fujifilm Medical Systems U.S.A., Inc.
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge (Suzhou) Co. Ltd.
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.K2M, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Lepu Medical Technology (beijing) Co., Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 9, 2021
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Marvao Medical Devices Ltd.
FDA (openFDA device enforcement)
Reported Jun 9, 2021
MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG; KIT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Minimed
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.