FDA Medical Device Recalls (openFDA)
Medline Industries, LP: Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.
- Recall number
- Z-3229-2026
- Recalling firm
- Medline Industries, LP
- Product
- Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.
- Status
- Open, Classified
- Initiated
- 2026-08-10
- Posted
- 2026-09-18
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- Firm began notifying consignees on August 10, 2026. Customers may continue to use Instrument Channel Brushes contained in Medline convenience kits in accordance with recommendations from the manufacturer of the brushes, Healthmark: Customers should be aware of possible sharp burrs when handling and utilizing Instrument Channel Brushes. If a sharp burr is discovered, discard or return the brush.
- Quantity
- 90 kits (US)
- Distribution
- US Nationwide distribution in the states of MN and SD.
- Lot, serial or model codes
- DYNJ48258D UDI-DI 10889942563272 Lots 23CBH459 23GBJ128 24ABM400
- 510(k) numbers
- ["K213481"]
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28