MEDLINE INDUSTRIES, LP - Northfield Non-sterile convenience kits: a recall — FDA Z-2230-2024
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Complete FDA and NHTSA recall records dated in July 2024.
These records include useful source details for the selected month.
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards…
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release…
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release…
A recall of lactose or lactose powder from Grande Ingredients in Wisconsin. The ingredient has the potential to be contaminated with Salmonella
Undeclared Yellow No. 5
Undeclared wheat and milk (foreign language labeling)
Foreign object, rubber, found in two tubs of Red Button Vintage Creamery Cookie Dough Ice Cream.
CGMP deviations
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
CGMP deviations
CGMP deviations
CGMP deviations
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
CGMP deviations
CGMP deviations
CGMP deviations
CGMP deviations
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Product labels state the incorrect expiration dates that extends beyond their true expiration date
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.