FDA Medical devices recall ·
Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING… recall
- Recall number
- Z-1331-2026
- Date
- (initiated December 24, 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
- 7380 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.
Why was it recalled?
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
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) Kit SKU DYNDH1576, UDI/DI 10193489437041, Lot Number 25EBP737; 2) Kit SKU RWM-DC57KC, UDI/DI 10889942582013, Lot Number 25EBE082.
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-1331-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.