Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1197-2026 — Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, Kit SKU DYNJ0415776Q; 3) DIVA PACK, Kit SKU DYNJ04811O; 4) DA VINCI PROSTATE/COLPOPEXY, Kit SKU DYNJ44864S; 5) MH ROBOTICS PACK, Kit SKU DYNJ50880L; 6) DELN

U.S. FDA — Device Enforcement · United States · 2025-12-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1197-2026
Date of alert: 2025-12-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medline Industries, LP
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10195327634827

Reported risk: Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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