Z-3229-2026 Class II Ongoing
FDA device recall Z-3229-2026 was initiated by Medline Industries, LP on Aug 10, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 90 kits (US).
Recall Details
- Product Type
- Devices
- Report Date
- Sep 30, 2026
- Initiation Date
- Aug 10, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 kits (US)
Product Description
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 Pattern
US Nationwide distribution in the states of MN and SD.
Code Information
DYNJ48258D UDI-DI 10889942563272 Lots 23CBH459 23GBJ128 24ABM400
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3229-2026
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026