🏥 Medical Devices Class I - Dangerous
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
All Recalls
95,114 total recalls in our database
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Terumo Cardiovascular Systems
🏥 Medical Devices Class I - Dangerous
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
🏥 Medical Devices Class I - Dangerous
The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain systems or come into contact with bleach they can produce cyanide gas. The solution in these tubes contains guanidine thiocynate and may put laboratory personnel at risk of exposure to cyanide gas when it comes into contact with bleach or reagents containing bleach.
🏥 Medical Devices Class I - Dangerous
The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cross-localization reference line may be inaccurately placed on any of the corresponding images that are open.
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
RANDOX LABORATORIES
🏥 Medical Devices Class I - Dangerous
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.
🏥 Medical Devices Class I - Dangerous
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
🏥 Medical Devices Class I - Dangerous
COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.
🏥 Medical Devices Class I - Dangerous
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Roche Diagnostics Operations
🏥 Medical Devices Class I - Dangerous
Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.
Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Terumo Cardiovascular Systems
🏥 Medical Devices Class I - Dangerous
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
RANDOX LABORATORIES
🏥 Medical Devices Class I - Dangerous
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.
🏥 Medical Devices Class I - Dangerous
Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
🏥 Medical Devices Class I - Dangerous
Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.
Caravan Sports Armed/Padded Arm Bagged Chairs
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The chair's plastic bracket can bend or fail, and cause the fabric seat to rip apart from the frame, posing fall and injury hazards to the user.
Kobalt Brand 40-volt Lithium Ion Cordless Electric Chainsaws
Changzhou Globe Co. Ltd., of China
🏠 Consumer Products Class III - Low Risk
The chainsaw can remain in the "on" position, posing a laceration hazard to consumers.
Kobalt brand 40-volt Lithium Ion 8-inch Cordless Electric Pole Saws
Changzhou Globe Co. Ltd., of China
🏠 Consumer Products Class III - Low Risk
The switch on the recalled pole saws can fail while under a heavy load, and cause the unit to continue running after the user releases the trigger, posing a laceration hazard to consumers.
Electric bicycles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
An improperly manufactured electrical cable can cause the bicycle to accelerate unexpectedly, posing a fall hazard to the user.
Sirrus, Sirrus X and Sirrus Sport Bicycles with alloy cranks
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The crank arm can disengage and cause the bicycle's rider to lose control, posing fall and injury hazards.
🍎 Food Class I - Dangerous
Product contains undeclared brazil nuts.