Complete FDA and NHTSA recall records dated in May 2021.
These records include useful source details for the selected month.
Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of…
On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been…
Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or…
Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.
Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a…
Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical…
Michigan Department of Agriculture and Rural Development sampled product and results found Listeria monocytogenes.
An incorrect label was applied to the back of ranch dressing bottles. The incorrect label contained the ingredient information for zesty Italian dressing which fails to disclose the…
Possible egg and wheat allergen cross-contact contamination during packaging.
Undeclared milk (lactose) allergen on labeling
Product potentially contains undeclared almonds.
Dark Chocolate walnuts were packed in a container labeled at Dark Chocolate Espresso Beans and does not declare walnuts as an allergen Bottom label with nutritional information is correct…
Product potentially contains undeclared almonds.
cGMP deviations
CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of…
Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type…
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus…
CGMP deviation: Product found to contain trace amounts of NMBA
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus…
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.
