Complete FDA and NHTSA recall records dated in 2018, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
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.
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper…
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
