Recall Z-2441-2026 ยท LRO General Surgery Tray
Medline Industries, LP
Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G DYNJ85197A DYNJT4007 BASIC ACCESS PACK-LF DYNJ36698B BASIC BACK TRAY DYNJ89037 BASIC PEDI PACK-LF DYNJ0171446I DYNJ0171446J BASIC SPINE DYNJ910915A BREAST PACK DYNJ87587A BREAST PLASTIC PACK DYNJ84482C C SECTION DYNJ49172I CAROTID ENDARTERECTOMY PACK DYNJ48013L CENTRAL LINE PACK-LF DYNJ0220136S CERVICA
| Date | Jun 12, 2026 (initiated Apr 27, 2026) |
| Status | Open, Classified |
| Reason | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 49,654 kits total |
| Distribution | US Nationwide distribution. OUS distribution pending. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213481 | Medline General Surgery Tray Medline Industries, Inc., May 24, 2022 |