← FDA ENFORCEMENT
Z-0510-2026Class II

Medline Industries, LP

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2025-11-26
Distribution
US: MO
Firm state
IL
Product quantity
1024 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.

Product description

MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.

Code / lot info

1) REF: DYNJ37743D: UDI/DI 10193489600124 (each), 40193489600125 (case), Lot Number 25EMI333; 2) REF: DYNJ37743F: UDI/DI 10198459390685 (each), 40198459390686 (case), Lot Number 25GMD927.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →