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Open, Classified

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

FDA Recall Z-3229-2026 · Posted 2026-09-18

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2026-08-10
Product Quantity90 kits (US)

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of MN and SD.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K213481Medline General Surgery TrayMedline Industries, Inc. · 2022-05-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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