Complete FDA and NHTSA recall records dated in May 2018.
These records include useful source details for the selected month.
The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct…
There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton…
Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.
There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.
FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for…
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
The secondary packaging is labeled with an incorrect expiration date.
A potential commingle that could result in the product in the package not matching the product on the outer label.
Products labeled for distribution outside the United States may have been distributed to customers in the United States.
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
Products recalled due to water phase salt deviations and mislabeling of storage instructions on finished products labels
Product may be contaminated with Listeria monocytogenes.
Izzy's is recalling Maple Nut ice cream after being notified by a supplier that they are recalling walnuts due to possible presence of undeclared peanut residue.
Vendor has determined that portions of a large raw material lot were positive for Salmonella.
Products recalled due to water phase salt deviations and mislabeling of storage instructions on finished products labels
Vendor has determined that portions of a large raw material lot were positive for Salmonella.
Some decorated (iced) Easter cookies in the shapes of eggs, bunnies and chicks sold in bulk bins in 9 northern CA Whole Foods locations do not properly declare egg as an ingredient or…
Shell eggs have the potential to be contaminated with Salmonella Braenderup.
During a FDA inspection, it was disclosed that the firm is not documenting the mixing time of the product nor is pH monitoring for each kettle/batch mixed being conducted. The product is a…
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
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.
