restor3d Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the recall — FDA Z-1026-2022
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Complete FDA and NHTSA recall records dated in May 2022.
These records include useful source details for the selected month.
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially…
When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Potential breach in the sterility barrier for tray ring covers.
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
There is a potential for foreign matter.
Potential to contain undeclared wheat and whey
Product contains undeclared sulfites and unallowed dye - Amaranth (E123) - Acid Red 27
Product contains undeclared sulfites.
Product contains undeclared sulfites.
Possible Listeria monocytogenes in product
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
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.