Complete FDA and NHTSA recall records dated in March 2018.
These records include useful source details for the selected month.
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause…
A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.
This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this…
Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic may have a defective component, which may result in loss of connection to the Information…
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily…
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily…
Product not meeting the iodine assay level requirements to support 36 month expiration dating.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily…
Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inability to power the system after shutdown, System stays in standalone mode, Image…
Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to…
A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of "QuikClot TraumaPad" pouch. The carton as well as the remaining 9 pouches were properly…
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.
Internal program testing shows that product may not reach the indicated expiration date.
The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent…
A warning is being added to the cobas 6000 MODULAR Series System - c501 and the cobas 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance.
Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality…
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily…
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily…
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
