PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Aesculap Implant Systems
Class I - Dangerous
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
NanoSight NS300
MALVERN PANALYTICAL
Class I - Dangerous
Product found to not comply to Class 1 Laser safety requirement.
CustMbite, Model Number CBT-SRS-UL
Dental Choice Holding
Class I - Dangerous
The device was marketed and sold in the US without FDA clearance.
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Aesculap Implant Systems
Class I - Dangerous
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Class I - Dangerous
Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.
Craftmatic Model 1 Base for Dual Bed Configurations
Craftmatic Industries
Class I - Dangerous
A potential for dual-configured beds to separate or slip away from one another.
Class I - Dangerous
There is the potential that during implant deployment, the device may not properly deliver a implant.
Turbett Surgical Container, TS1500
Turbett Surgical
Class I - Dangerous
Devices were subject to unapproved rework processes.
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
Siemens Healthcare Diagnostics
Class I - Dangerous
Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.
Class I - Dangerous
Product may be mislabeled.
Merlin.net model MN5000 Software
St. Jude Medical, Cardiac Rhythm Management Division
Class I - Dangerous
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
Class I - Dangerous
Product may be mislabeled.
MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A, MSC351430AZ
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
stability failure
Legacy Base for Dual Bed Configurations
Craftmatic Industries
Class I - Dangerous
A potential for dual-configured beds to separate or slip away from one another.
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
North American Diagnostics
Class I - Dangerous
Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Class I - Dangerous
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
Centricity PACS Software Version 7.0 SP0.0.4.7
GE Healthcare
Class I - Dangerous
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Fresenius Medical Care Holdings
Class I - Dangerous
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
SIGHT DIAGNOSTICS
Class I - Dangerous
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range.
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.