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 Sep 22, 2021
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
FDA (openFDA device enforcement)
Reported Sep 22, 2021
Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accora Inc.
FDA (openFDA device enforcement)
Reported Sep 22, 2021
Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arjohuntleigh Magog, Inc.
FDA (openFDA device enforcement)
Reported Sep 22, 2021
AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Armstrong Medical Services Limited
FDA (openFDA device enforcement)
Reported Sep 22, 2021
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion
14 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 22, 2021
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cellex
FDA (openFDA device enforcement)
Reported Sep 22, 2021
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cordis Corporation
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 22, 2021
McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cypress Medical Products LLC
FDA (openFDA device enforcement)
Reported Sep 22, 2021
Arjo Disposable Repositioning Sling, Model AHD001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge Dominican Republic SA
FDA (openFDA device enforcement)
Reported Sep 22, 2021
Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Gibson Bioscience
FDA (openFDA device enforcement)
Reported Sep 22, 2021
Medtronic HVAD Pump Implant Kits
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heartware, Inc.
FDA (openFDA device enforcement)
Reported Sep 22, 2021
The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hero Health
FDA (openFDA device enforcement)
Reported Sep 22, 2021
BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leica Microsystems, Inc.
FDA (openFDA device enforcement)
Reported Sep 22, 2021
Verigene EP Amplification Reagent Kit Test
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Corporation
FDA (openFDA device enforcement)
Reported Sep 22, 2021
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pentax
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 22, 2021
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 22, 2021
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quidel Corporation
FDA (openFDA device enforcement)
Reported Sep 22, 2021
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
FDA (openFDA device enforcement)
Reported Sep 22, 2021
ACUSON Juniper Diagnostic Ultrasound System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Sep 22, 2021
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material…
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 Sep 22, 2021
Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Welch Allyn Inc.
FDA (openFDA device enforcement)
Reported Sep 15, 2021
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 15, 2021
LiquaSonic Ultrasound Gel 250mL, Model No. 001205
High riskUsing this product could cause serious injury, illness or death — stop using it now.Athena Medical Products Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 15, 2021
COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Copan Italia
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.