FDA Medical devices recall ·
Medline Kits containing B. Braun IV Administration Sets and Pump… recall
- Recall number
- Z-1054-2026
- Date
- (initiated November 26, 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
- 16 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
Why was it recalled?
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
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
UDI/DI 10193489587869 (EA) 40193489587860 (CS), Lot Number 25HBQ850
Distribution
US Nationwide distribution.
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-1054-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.