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 Mar 16, 2022
CoolSeal Generator, REF: CSL-200-50
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bolder Surgical, LLC
FDA (openFDA device enforcement)
Reported Mar 16, 2022
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Brainlab AG
FDA (openFDA device enforcement)
Reported Mar 16, 2022
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carl Zeiss Meditec, Inc.
FDA (openFDA device enforcement)
Reported Mar 16, 2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Celltrion USA Inc.
FDA (openFDA device enforcement)
Reported Mar 16, 2022
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cytocell Ltd.
FDA (openFDA device enforcement)
Reported Mar 16, 2022
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Envisiontec US LLC
FDA (openFDA device enforcement)
Reported Mar 16, 2022
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ev3 Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 16, 2022
HeartWare Ventricular Assist Device (HVAD) System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heartware, Inc.
FDA (openFDA device enforcement)
Reported Mar 16, 2022
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ion Beam Applications S.A.
FDA (openFDA device enforcement)
Reported Mar 16, 2022
LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
High riskUsing this product could cause serious injury, illness or death — stop using it now.Lusys Laboratories, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 16, 2022
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
Reported Mar 16, 2022
NIM TRIVANTAGE EMG Endotracheal Tube
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
FDA (openFDA device enforcement)
Reported Mar 16, 2022
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NeuMoDx Molecular Inc.
FDA (openFDA device enforcement)
Reported Mar 16, 2022
Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nextremity Solutions
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 16, 2022
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Mar 16, 2022
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird…
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 Mar 16, 2022
HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Physio-Control, Inc.
FDA (openFDA device enforcement)
Reported Mar 16, 2022
RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 ,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
FDA (openFDA device enforcement)
Reported Mar 16, 2022
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel Inc.
FDA (openFDA device enforcement)
Reported Mar 16, 2022
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
FDA (openFDA device enforcement)
Reported Mar 9, 2022
Alinity m Integrated Reaction Units (IRU)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
FDA (openFDA device enforcement)
Reported Mar 9, 2022
Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Acorn Stairlifts, Inc.
FDA (openFDA device enforcement)
Reported Mar 9, 2022
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Mar 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioPro, Inc.
9 more products 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.