FDA recall Z-1335-2026

Medline Industries, LP · Class II · device

Product

Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-12-24
Report date
2026-02-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1335-2026