HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
Haimen Shengbang Laboratory Equipment Co.
Class I - Dangerous
Distributed VTM outside of VTM Guidance and without clearance.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
Haimen Shengbang Laboratory Equipment Co.
Class I - Dangerous
Distributed VTM outside of VTM Guidance and without clearance.
Merlin 2 PCS MER37000 programmer Model MER3400 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.
Merlin PCS 3650 programmer Model 3330 software
St. Jude Medical, Cardiac Rhythm Management Division
Class I - Dangerous
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
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.
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.
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.
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.
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.
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.
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.
Kits contain leaking bottles of isopropyl alcohol
Class I - Dangerous
Kits contain leaking bottles of isopropyl alcohol
nordicBrainEX, software versions 2.21 through 2.3.10
NordicNeuroLab AS
Class I - Dangerous
When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.
Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131
MEDLINE INDUSTRIES, LP - SPT
Class I - Dangerous
Kits contain leaking bottles of isopropyl alcohol
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
Intuitive Surgical
Class I - Dangerous
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.