FDA recall Z-3229-2026

Medline Industries, LP · Class II · device

Product

Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.

Reason for recall

Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.

Distribution

US Nationwide distribution in the states of MN and SD.

Key facts

Status
Ongoing
Initiation date
2026-08-10
Report date
2026-09-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3229-2026