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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Dec 25, 2024
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model #…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Augustine Temperature Management, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE OEC Medical Systems, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Kirwan Surgical Products, LLC
6 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neurosurgery
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MicroPort Orthopedics Inc.
FDA (openFDA device enforcement)
Reported Dec 25, 2024
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mint Medical GmbH
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Galaxy System (GAL-001)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Noah Medical
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Duravent Silicone Ventilation Tube. Model Number: 240075.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spacelabs Healthcare, Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
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)
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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.