FDA recall Z-0922-2026

Medline Industries, LP · Class II · device

Product

FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048

Reason for recall

The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.

Distribution

US Nationwide distribution in the states CA, CO, IL, KS, and MI.

Key facts

Status
Ongoing
Initiation date
2025-11-13
Report date
2025-12-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0922-2026