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 11, 2022
K-Wire, 1.35 mm x 170 mm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arthrex, Inc.
FDA (openFDA device enforcement)
Reported May 11, 2022
First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aso LLC
FDA (openFDA device enforcement)
Reported May 11, 2022
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported May 11, 2022
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported May 11, 2022
VELYS Robotic-Assisted Solution Base Product No.: 451570100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
FDA (openFDA device enforcement)
Reported May 11, 2022
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Johnson & Johnson Surgical Vision Inc.
FDA (openFDA device enforcement)
Reported May 11, 2022
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported May 11, 2022
Azurion systems with software release R1.x
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported May 11, 2022
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.restor3d Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 11, 2022
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 11, 2022
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
High riskUsing this product could cause serious injury, illness or death — stop using it now.SML Distribution, LLC
FDA (openFDA device enforcement)
Reported May 4, 2022
PrisMax System, Product Code 955626
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 4, 2022
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 4, 2022
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carl Zeiss Meditec AG
FDA (openFDA device enforcement)
Reported May 4, 2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
High riskUsing this product could cause serious injury, illness or death — stop using it now.Celltrion USA Inc.
FDA (openFDA device enforcement)
Reported May 4, 2022
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draegar Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported May 4, 2022
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Freudenberg Medical, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 4, 2022
ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
FDA (openFDA device enforcement)
Reported May 4, 2022
da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported May 4, 2022
Puritan Bennett 980 Series Ventilator
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic formerly Covidien
FDA (openFDA device enforcement)
Reported May 4, 2022
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported May 4, 2022
NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NeuMoDx Molecular Inc.
FDA (openFDA device enforcement)
Reported May 4, 2022
RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diabetes Care, Inc.
FDA (openFDA device enforcement)
Reported May 4, 2022
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
2 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.