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 Aug 11, 2021
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tenderneeds Fertility LLC
8 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 11, 2021
GlideScope Go Monitors
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Verathon, Inc.
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
FDA (openFDA device enforcement)
Reported Aug 4, 2021
CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperVision Inc.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 4, 2021
CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cytocell Ltd.
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Eight Medical International BV
FDA (openFDA device enforcement)
Reported Aug 4, 2021
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Aug 4, 2021
OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE OEC Medical Systems, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hill-Rom, Inc.
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Innovative Tomography Product GmbH
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Proteus 235-Proton Therapy System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ion Beam Applications S.A.
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 4, 2021
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Aug 4, 2021
RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
FDA (openFDA device enforcement)
Reported Aug 4, 2021
ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel Inc.
FDA (openFDA device enforcement)
Reported Aug 4, 2021
OxyMask O2 Adult REF OM-1125-14
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Southmedic, Inc.
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sunrise Medical (US) LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arthrex, Inc.
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Caption Health
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cell Marque Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dutch Ophthalmic USA, Inc.
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.