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U.S. Department of Health and Human Services

Class 2 Device Recall Medline General Surgery Tray

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 Class 2 Device Recall Medline General Surgery Traysee related information
Date Initiated by FirmAugust 10, 2026
Date PostedSeptember 18, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3230-2026
Recall Event ID 99729
Product Classification Ear, nose, and throat surgical tray - Product Code OGR
ProductMedline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F.
Code Information DYNJ48258F UDI-DI 10198459038334 Lots 24HBR684 25CBS234 25GBH438 25JBC863 26FBU052
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
800-633-5463
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionFirm 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 Commerce90 kits (US)
DistributionUS Nationwide distribution in the states of MN and SD.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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