CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report

Medline convenience kits containing Healthmark Instrument recalled

Medline Industries is recalling Medline convenience kits containing Healthmark Instrument Channel Brushes, distributed nationwide in the US. The recall was initiated on 10 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDYNJ48258F UDI-DI 10198459038334 Lots 24HBR684 25CBS234 25GBH438 25JBC863 26FBU052
Quantity recalled90 kits (US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-3230-2026
FDA event ID
99729
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
10 Aug 2026
FDA classified
18 Sep 2026
Reported
30 Sep 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

10 Aug 2026Recall initiated by company
18 Sep 2026Classified by FDA+39 days
30 Sep 2026Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of MN and SD.

Nationwide MinnesotaSouth Dakota

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

DYNJ48258F UDI-DI 10198459038334 Lots 24HBR684 25CBS234 25GBH438 25JBC863 26FBU052

Where was it sold?

US Nationwide distribution in the states of MN and SD.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99729

This product is part of a recall event; the main page for the event is Medline convenience kits containing Healthmark Instrument recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIMedline convenience kits containing Healthmark Instrument recalledMedline IndustriesOtherNationwide

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