Class II

Medical Device Recall: Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505

MEDLINE INDUSTRIES, LP - Northfield · February 23, 2024

Reason for Recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Distribution

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

States Affected

NATIONWIDE

Quantity Affected

440 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1433-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

MEDLINE INDUSTRIES, LP - Northfield Medical Device Recall: Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505 | SafeCheck