MAJOR THORACOSCOPY BASIN. Medical convenience kit.
AVID Medical
🏥 Medical Devices Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
All Recalls
95,075 total recalls in our database
PARTIAL NEPHRECTOMY PACK. Medical convenience kit.
AVID Medical
🏥 Medical Devices Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
🏥 Medical Devices Class I - Dangerous
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
🏥 Medical Devices Class I - Dangerous
Laryngoscope handles may not illuminate as intended.
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
Beckman Coulter
🏥 Medical Devices 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
🏥 Medical Devices 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).
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
GENERAL ROBOTIC PACK. Medical convenience kit.
AVID Medical
🏥 Medical Devices Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
DAVINCI UROLOGY. Medical convenience kit.
AVID Medical
🏥 Medical Devices Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
🏥 Medical Devices Class I - Dangerous
Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
GS ENDOSCOPY PACK. Medical convenience kit.
AVID Medical
🏥 Medical Devices 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)
🏥 Medical Devices Class I - Dangerous
Laryngoscope handles may not illuminate as intended.
CT DAVINCI. Medical convenience kit.
AVID Medical
🏥 Medical Devices Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
Beckman Coulter
🏥 Medical Devices 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.
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
🏥 Medical Devices Class I - Dangerous
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
DA VINCI PACK URO/PROSTATE. Medical convenience kit.
AVID Medical
🏥 Medical Devices Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.