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 Mar 27, 2024
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Moderate riskThis product could cause temporary or reversible health problems — stop using it.In2Bones, SAS
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Landauer
FDA (openFDA device enforcement)
Reported Mar 27, 2024
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mc3 Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mckesson Medical-Surgical Inc. Corporate Office
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Medtronic DLP Vessel Cannula, Model Number REF 30000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Mar 27, 2024
TENSIVE Conductive Adhesive Gel, REF 016-401600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Natus Neurology Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preat Corp.
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sarnova HC, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
DCA Systems HbA1c Reagent Kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Mar 27, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
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 Mar 27, 2024
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Think Surgical, Inc.
FDA (openFDA device enforcement)
Reported Mar 27, 2024
impression coping, repositionable, short, screw-retained, PF 4.0
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Thommen Medical AG
FDA (openFDA device enforcement)
Reported Mar 27, 2024
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Thoratec Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 20, 2024
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 20, 2024
BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beaver Visitec International, Inc.
FDA (openFDA device enforcement)
Reported Mar 20, 2024
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biosense Webster, Inc.
FDA (openFDA device enforcement)
Reported Mar 20, 2024
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 20, 2024
CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Mar 20, 2024
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medos International Sarl
FDA (openFDA device enforcement)
Reported Mar 20, 2024
D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Peter Lazic GmbH
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.