Complete FDA and NHTSA recall records dated in July 2020.
These records include useful source details for the selected month.
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure…
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure…
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with…
Failures were found in the temperature measurement function while in the predict mode.
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with…
Product may contain foreign object.
Product may contain undeclared egg white.
Product may contain undeclared milk. Chocolate Peanut Butter ice cream may be filled in pint sized Dairy-Free Chocolate Peanut Butter containers that have a lid labeled Chocolate Peanut…
Products may contain undeclared walnuts.
Undeclared sesame seeds, poppy seeds, and dehydrated garlic.
The firm was notified by a customer that the product contains cashews which are not listed in the ingredient statement.
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.
Incorrect product labeling.
Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off
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.
