Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L
FDA device recall Z-2420-2026 · posted 2026-06-12 · Open, Classified
Recall details
- Recalling firm
- Medline Industries, LP
- Reason for recall
- Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Action taken
- Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- OFG
- Quantity affected
- 49,654 kits total
- Distribution
- US Nationwide distribution. OUS distribution pending.
- Date initiated
- 2026-04-27
- Date posted
- 2026-06-12
- Location
- Northfield, IL
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