Z-3229-2026Class II

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

Name: Z-3229-2026 Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus...
Creator: Medline Industries, LP
Published: 2026-08-10
License: https://open.fda.gov/license/

Medline Industries, LP / initiated 2026-08-10 / Open, Classified

FDA source

Recall record

Recall number: Z-3229-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-10
Posted: 2026-09-18
Recalling firm: Medline Industries, LP
Product: Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.
Product code: LRO General Surgery Tray
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.
FDA 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 in commerce: 90 kits (US)
Distribution: US Nationwide distribution in the states of MN and SD.
Product codes and lots: DYNJ48258D UDI-DI 10889942563272 Lots 23CBH459 23GBJ128 24ABM400

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3229-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3229-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3230-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18

Product code LRO

K213481Class IIMedline General Surgery TrayMedline Industries, Inc. / cleared 2022-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)