FDA Medical devices recall ·
Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT… recall
- Recall number
- Z-1329-2026
- 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
- 7570 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING CHANGE W/ TEG CHG, Kit SKU DYNDC3222A; 7) PICC PROCEDURE PACK, Kit SKU DYNJ59067A; 8) PICC PROCEDURE PACK, Kit SKU PHS950205004B.
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 DT22710, Lot Numbers: 25EBC812; 2) Kit SKU DYNDA1857A, Lot Numbers: 25FBH991; 3) Kit SKU DYNDC1978A, Lot Numbers: 25EBC577; 4) Kit SKU DYNDC2367, Lot Numbers: 25EBS434; 5) Kit SKU DYNDC2407B, Lot Numbers: 25FMG170; 6) Kit SKU DYNDC3222A, Lot Numbers: 25EBK184; 7) Kit SKU DYNJ59067A, Lot Numbers: 25EBM461, 25EBD386; 8) Kit SKU PHS950205004B, Lot Numbers: 25FMD059.
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-1329-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.