Medline Industries, LP recalls Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK D…
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus PackDYNJ48258FUDI-DI 108899425632723 affected lots23CBH45923GBJ12824ABM400
What the firm is doing
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.
DistributionShow detailsHide
US Nationwide distribution in the states of MN and SD.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3229-2026
- FDA 510(k) clearance · K213481The device's official FDA premarket clearance record
- FDA device classification · LROOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4370The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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