FDA Medical devices recall ·
MEDLINE STERILE BASIC EYE PACK 16: 1) recall
- Recall number
- Z-0510-2026
- Date
- (initiated October 3, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1024 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Why was it recalled?
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) REF: DYNJ37743D: UDI/DI 10193489600124 (each), 40193489600125 (case), Lot Number 25EMI333; 2) REF: DYNJ37743F: UDI/DI 10198459390685 (each), 40198459390686 (case), Lot Number 25GMD927.
Distribution
US: MO
States: Missouri
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0510-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.