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 May 4, 2022
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported May 4, 2022
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported May 4, 2022
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 4, 2022
TearCare version 1.0 SmartHubs
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sight Sciences, Inc.
FDA (openFDA device enforcement)
Reported May 4, 2022
Smart Toe II Intramedullary Arthrodesis Implant
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
FDA (openFDA device enforcement)
Reported May 4, 2022
WAVES WCM Kidney Cassette Module
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waters Medical Systems LLC
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Acon Biotech (Hangzhou) Co., Ltd.
FDA (openFDA device enforcement)
Reported Apr 27, 2022
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Acumed LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Apr 27, 2022
ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DNA Genotek Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 27, 2022
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Apr 27, 2022
HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Huntleigh Healthcare Ltd.
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Matrix Clinical Solution At-Home COVID-19 Test
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Matrix Medical Network
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 27, 2022
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Qiagen Sciences LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Resource Optimization & Innovation LLC
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Respironics California, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Virus Counter Platform with Model Name VC3100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sartorius Corporation
FDA (openFDA device enforcement)
Reported Apr 27, 2022
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 &…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
17 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 27, 2022
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sight Diagnostics Ltd.
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.