The Recall Desk
ModerateFDA (Devices)·Z-1197-2026·Announced 2026-02-04

Gynecology and prostate packs recalled over cracking adhesive tubing

Medline is recalling 1,928 total of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record cites a supplier component recall over cracking tubing with no stated consequence or reported harm.

Plain-English summary

Medline medical procedure convenience kits are being recalled by Medline Industries, LP, covering the RR-GYN Laparoscopy Pack-LF under Medline kit SKU DYNJ0395022O, the Pelviscopy Pack-LF under SKU DYNJ0415776Q, the Diva Pack under SKU DYNJ04811O and the Da Vinci Prostate/Colpopexy kit under SKU DYNJ44864S, among the kits listed in the enforcement record.

The record states the 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.

The record lists 1,928 total, with kit SKUs, UDI/DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.

The record describes a component recalled at the supplier and states no further consequence or reported injuries. Facilities should quarantine affected kits and follow Medline's instructions.

The recalled product

Product
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 D
Manufacturer
Medline Industries, LP
Category
Medical Device — Procedure kit
Hazard
Affected units
1,928

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • Medline Kit SKU DYNJ0395022O: UDI/DI 10195327634827 (EA) 40195327634828 (CS)
  • Lot Number 25KME682
  • Medline Kit SKU DYNJ0415776Q: UDI/DI 10198459566806 (EA) 40198459566807 (CS)
  • Lot Number 25KMH125
  • Medline Kit SKU DYNJ04811O: UDI/DI 10198459440953 (EA) 40198459440954 (CS)
  • Lot Number 25KMD772
  • Medline Kit SKU DYNJ44864S: UDI/DI 10195327127626 (EA) 40195327127627 (CS)
  • Lot Number 25LMA115
  • Medline Kit SKU DYNJ50880L: UDI/DI 10198459388002 (EA) 40198459388003 (CS)
  • Lot Number 25LMA516
  • Medline Kit SKU DYNJ82244B: UDI/DI 10198459344053 (EA) 40198459344054 (CS)
  • Lot Number 25KMF328
  • Medline Kit SKU DYNJ82761B: UDI/DI 10198459039232 (EA) 40198459039233 (CS)
  • Lot Number 25LMA391
  • Medline Kit SKU DYNJT4964: UDI/DI 10198459460098 (EA) 40198459460099 (CS)
  • Lot Number 25KMJ341.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

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