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 Oct 2, 2024
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
FDA (openFDA device enforcement)
Reported Oct 2, 2024
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic Inc.
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
7 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microcare Medical
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
12 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
FDA (openFDA device enforcement)
Reported Oct 2, 2024
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Spine
FDA (openFDA device enforcement)
Reported Oct 2, 2024
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.T.G. Eakin Limited
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.TMJ Solutions Inc.
FDA (openFDA device enforcement)
Reported Oct 2, 2024
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Corp. Hq.)
FDA (openFDA device enforcement)
Reported Oct 2, 2024
GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wipro GE Healthcare Private Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Btt Health GmbH
FDA (openFDA device enforcement)
Reported Sep 25, 2024
BiomarC EX Fiducial Marker System, Catalog Number 040165
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Carbon Medical Technologies, Inc.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
4 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.