Recall Z-2422-2026 ยท FDE Laparoscopy Kit
Medline Industries, LP
Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC + DYNJ904119O BARIATRIC CDS CDS983883J BWNBORO LAP CHOLE PACK-LF DYNJ32836B CCSB KARIN JWIRE LUMPECTOMY DYNJ910459B CHRISTUS CHILDRENS LAP CHOLE DYNJ61165G CUH MINOR PACK-LF DYNJ60095B FREE FLAP CUSTOM PACK B DYNJ82736B FREE NIPPLE GRAFT DYNJ911160B GEN MINOR DYNJ900906L GEN SURG LAPAROSCOPY PACK DYNJ55248F
| 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
This recall record lists no 510(k) number.