Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and SINUS PACK DYNJ48
Summary
The FDA issued a Class II for Medline convenience kits containing Healthmark Instrument Channel Brushes. SIN by Medline Industries, LP. Reason: 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 t.
Details
Source
Device Recall
External ID
Z-3230-2026
Action Date
2026-09-30
Status
Ongoing
Category
device
Product Description
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F.
Lot/Code Info: DYNJ48258F UDI-DI 10198459038334 Lots 24HBR684 25CBS234 25GBH438 25JBC863 26FBU052
Quantity Affected: 90 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.
Distribution
US Nationwide distribution in the states of MN and SD.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-10
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 196 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Medline Industries, LP has 577 FDA actions in our database, including 553 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 577 FDA actions in our database, including 553 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3230-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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