FDA Medical devices recall ·
Medline procedure kits, labeled as: 1) WOUND CARE TRAY recall
- Recall number
- Z-1711-2025
- Date
- (initiated March 19, 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
- 5200 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
Why was it recalled?
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
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 DYNDA1412A: UDI/DI 10193489693423 (EA) 40193489693424 (CS), Lot Numbers: 23KBH040; 2) REF DYNDL1263A: UDI/DI 10884389347126 (EA) 40884389347127 (CS), Lot Numbers: 23KBD401.
Distribution
Worldwide distribution - US Nationwide and the countries of Panama and Canada.
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-1711-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.