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 25, 2024
Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spectranetics Corporation
FDA (openFDA device enforcement)
Reported Dec 18, 2024
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Dec 18, 2024
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
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 Dec 18, 2024
BD Pyxis MedStation ES, REF: 323
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 18, 2024
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diasorin Inc.
FDA (openFDA device enforcement)
Reported Dec 18, 2024
DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Folsom Metal Products, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 18, 2024
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hermes Medical Solutions AB
FDA (openFDA device enforcement)
Reported Dec 18, 2024
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Dec 18, 2024
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
FDA (openFDA device enforcement)
Reported Dec 18, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Micro-X Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 18, 2024
Microscissor Tip (Disposable); Microline Catalog #: 3122.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microline Surgical, Inc.
FDA (openFDA device enforcement)
Reported Dec 18, 2024
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Noah Medical
FDA (openFDA device enforcement)
Reported Dec 18, 2024
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported Dec 11, 2024
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advanced Medical Solutions Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2024
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
13 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2024
Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cartiva, Inc.
FDA (openFDA device enforcement)
Reported Dec 11, 2024
Fusion Pro 24, Model 17000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Epilog Laser Corp.
FDA (openFDA device enforcement)
Reported Dec 11, 2024
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare (China) Co., Ltd.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2024
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
27 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2024
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Dec 11, 2024
Ziehm Solo. Digital Mobile C-arm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthoscan, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2024
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Dec 11, 2024
Atellica CI Analyzer. Catalog Numbers: 10947347.
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 11, 2024
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Inc.
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.