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 12, 2025
BD BBL TB Stain Kit K, Catalog (REF): 212522
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Biosense Webster, Inc.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hiossen Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2025
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Human Med Ag
FDA (openFDA device enforcement)
Reported Mar 12, 2025
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kung Shin Plastics Co. Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2025
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lumenis, Ltd.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medimaps Group
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Paradigm REF: MMT-712 and MMT-715
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Micro Therapeutics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2025
MIM software; System, Image Processing, Radiological
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MIM Software Inc.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Vios Monitoring System Bedside Monitor Model BSM2050
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Murata Vios, Inc.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Philips IntelliSpace Cardiovascular software, Model 830089.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.V.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.TAS Medical Inc.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Telcare, LLC
FDA (openFDA device enforcement)
Reported Mar 5, 2025
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Laboratory Systems (suzhou) Co., Ltd.
FDA (openFDA device enforcement)
Reported Mar 5, 2025
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2025
SIGNA Creator, SIGNA Explorer, NMRI systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare (China) Co., Ltd.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2025
IntelePACS (Image Fusion Module) - InteleViewer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intelerad Medical Systems Incorporated
FDA (openFDA device enforcement)
Reported Mar 5, 2025
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leica Biosystems Nussloch GmbH
FDA (openFDA device enforcement)
Reported Mar 5, 2025
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pentax
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2025
LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, Inc.
FDA (openFDA device enforcement)
Reported Mar 5, 2025
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Scientia Vascular, 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.