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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Oct 2, 2024
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Argon Medical Devices, Inc.
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ARROW INTERNATIONAL Inc.
FDA (openFDA device enforcement)
Reported Oct 2, 2024
BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Oct 2, 2024
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
30 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile;…
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 Oct 2, 2024
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Centinel Spine, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Biotech, Inc.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datascope Corp.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr Franz Koehler Chemie GmbH
FDA (openFDA device enforcement)
Reported Oct 2, 2024
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fisher & Paykel Healthcare, Ltd.
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
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)
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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.