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 Apr 14, 2021
Enteral Infusion Pump
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
FDA (openFDA device enforcement)
Reported Apr 14, 2021
EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Clerio Vision
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fenwal Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fujifilm Medical Systems U.S.A., Inc.
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Drop Arm Versamode"
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Gf Health Products
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Heartware, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
FDA (openFDA device enforcement)
Reported Apr 14, 2021
CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported Apr 14, 2021
A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Apr 14, 2021
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nuvasive Specialized Orthopedics Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Regard, Item Number 830067009, custom cardiovascular procedure kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Apr 14, 2021
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sharp Medical Products
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
High riskUsing this product could cause serious injury, illness or death — stop using it now.Tenacore LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 14, 2021
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tenderneeds Fertility LLC
9 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
FDA (openFDA device enforcement)
Reported Apr 7, 2021
Alcon Custom Ophthalmic Surgical Procedure Packs
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research, LLC
FDA (openFDA device enforcement)
Reported Apr 7, 2021
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arthrex, Inc.
FDA (openFDA device enforcement)
Reported Apr 7, 2021
BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biocare Medical, LLC
FDA (openFDA device enforcement)
Reported Apr 7, 2021
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Apr 7, 2021
CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 7, 2021
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 7, 2021
LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diasorin 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.