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 Dec 15, 2021
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 8, 2021
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beeken Biomedical, LLC
FDA (openFDA device enforcement)
Reported Dec 8, 2021
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Dec 8, 2021
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
7 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 8, 2021
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Cardiac Assist, Inc.
FDA (openFDA device enforcement)
Reported Dec 8, 2021
Total Thyroxine (T4) ELISA; REF EIA-1781
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DRG International, Inc.
FDA (openFDA device enforcement)
Reported Dec 8, 2021
GE Centricity Universal Viewer Zero Footprint Client
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Dec 8, 2021
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 8, 2021
The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Magnolia Medical Technologies, Inc.
FDA (openFDA device enforcement)
Reported Dec 8, 2021
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Max Lux Corp.
FDA (openFDA device enforcement)
Reported Dec 8, 2021
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NuVasive Specialized Orthopedics, Inc.
FDA (openFDA device enforcement)
Reported Dec 8, 2021
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.O&m Halyard Inc.
FDA (openFDA device enforcement)
Reported Dec 8, 2021
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
FDA (openFDA device enforcement)
Reported Dec 8, 2021
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 8, 2021
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Thoratec Corp.
FDA (openFDA device enforcement)
Reported Dec 8, 2021
INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 1, 2021
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 1, 2021
The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
FDA (openFDA device enforcement)
Reported Dec 1, 2021
BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson Infusion Therapy Systems Inc.
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Dec 1, 2021
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
FDA (openFDA device enforcement)
Reported Dec 1, 2021
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
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.