ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.
AVID Medical
Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
GENERAL LAPAROSCOPY TRAY. Medical convenience kit.
AVID Medical
Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
GEN LAPAROSCOPY PACK. Medical convenience kit.
AVID Medical
Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Class I - Dangerous
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
LAPAROSCOPY PACK. Medical convenience kit.
AVID Medical
Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
MAJOR THORACOSCOPY BASIN. Medical convenience kit.
AVID Medical
Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
PARTIAL NEPHRECTOMY PACK. Medical convenience kit.
AVID Medical
Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Class I - Dangerous
Laryngoscope handles may not illuminate as intended.
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
Beckman Coulter
Class I - Dangerous
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
DRG International
Class I - Dangerous
An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).
Class I - Dangerous
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
HVI CARDIAC ROBOT PACK. Medical convenience kit.
AVID Medical
Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
GENERAL ROBOTIC PACK. Medical convenience kit.
AVID Medical
Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Class I - Dangerous
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
CARDIAC ROBOT PACK. Medical convenience kit.
AVID Medical
Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
DAVINCI UROLOGY. Medical convenience kit.
AVID Medical
Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
GS ENDOSCOPY PACK. Medical convenience kit.
AVID Medical
Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
Flexicare Medical (Dongguan)
Class I - Dangerous
Laryngoscope handles may not illuminate as intended.
CT DAVINCI. Medical convenience kit.
AVID Medical
Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
Beckman Coulter
Class I - Dangerous
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.