Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
All Recalls
95,018 total recalls in our database
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
🏥 Medical Devices Class I - Dangerous
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
🏥 Medical Devices Class I - Dangerous
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
Philips Respironics
🏥 Medical Devices Class I - Dangerous
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
Maquet Cardiovascular
🏥 Medical Devices Class I - Dangerous
Some batches of product were not sterilized to their minimum sterilization specification.
🏥 Medical Devices Class I - Dangerous
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
Abbott Diabetes Care
🏥 Medical Devices Class I - Dangerous
Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
Biosense Webster
🏥 Medical Devices Class I - Dangerous
Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
🏥 Medical Devices Class I - Dangerous
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
🏥 Medical Devices Class I - Dangerous
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
🏥 Medical Devices Class I - Dangerous
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
🏥 Medical Devices Class I - Dangerous
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
BISSELL® Cordless Multi-Surface Wet Dry Vacuums Models 2551R and 25518
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The circuit board inside the vacuum's battery pack can overheat and smoke, posing a fire hazard.
BLÅVINGAD fishing games
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
A small metal rivet within a wooden play piece can come loose and detach, posing a choking hazard to young children.
Alugator Ride 3.0 Hoe and Alugator Ride SE avalanche shovels
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The spring locking mechanism on the recalled avalanche shovels can fail in an emergency excavation of a person buried by an avalanche, posing a risk of injury or death for the buried person.
Basket with Balls toys sold with Monti Kids Tummy-Time, 4-6M Play and Early Gross Motor subscription boxes
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The swirls sewn onto the exterior of the blue crocheted ball can separate, exposing small parts, posing a choking hazard to young children.
🍎 Food Class I - Dangerous
Seasoned Dried Pollack was recalled due to undeclared Fish (Pollack), Wheat, Soybean.