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 Aug 24, 2022
Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Trinity Sterile, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 17, 2022
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
FDA (openFDA device enforcement)
Reported Aug 17, 2022
The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alere San Diego, Inc.
FDA (openFDA device enforcement)
Reported Aug 17, 2022
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Corin Ltd.
FDA (openFDA device enforcement)
Reported Aug 17, 2022
Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Aug 17, 2022
HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box. Intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Guangdong Haiou Medical Apparatus Co., Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 17, 2022
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
High riskUsing this product could cause serious injury, illness or death — stop using it now.Haimen Shengbang Laboratory Equipment Co. Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 17, 2022
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Modeling, Inc.
FDA (openFDA device enforcement)
Reported Aug 17, 2022
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 17, 2022
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Aug 17, 2022
cobas e801 Immunoassay Analyzer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
FDA (openFDA device enforcement)
Reported Aug 17, 2022
Xhibit Telemetry Receiver, Model: 96280
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spacelabs Healthcare, Inc.
FDA (openFDA device enforcement)
Reported Aug 10, 2022
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 10, 2022
EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 10, 2022
Craftmatic Model 1 Base for Dual Bed Configurations
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Craftmatic Industries, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 10, 2022
CustMbite, Model Number CBT-SRS-UL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dental Choice Holding LLC
FDA (openFDA device enforcement)
Reported Aug 10, 2022
The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Aug 10, 2022
NanoSight NS300
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Malvern Panalytical Ltd.
FDA (openFDA device enforcement)
Reported Aug 10, 2022
MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Aug 10, 2022
Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Aug 10, 2022
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Neotract Inc.
FDA (openFDA device enforcement)
Reported Aug 10, 2022
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML…
High riskUsing this product could cause serious injury, illness or death — stop using it now.North American Diagnostics
FDA (openFDA device enforcement)
Reported Aug 10, 2022
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Aug 10, 2022
Merlin PCS 3650 programmer Model 3330 software
Moderate riskThis product could cause temporary or reversible health problems — stop using it.St. Jude Medical, Cardiac Rhythm Management Division
2 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.