# FDA recall Z-1197-2026

> **Medline Industries, LP** · Class II · device recall initiated 2025-12-12.

## 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 DYNJ50880L;   6)	DELNOR LAPAROSCOPIC GYN PACK, Kit SKU DYNJ82244B;   7)	ROBOT PACK, Kit SKU DYNJ82761B;   8)	GENERAL ROBOTICS PACK, Kit SKU DYNJT4964.

## Reason for recall

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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1197-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-12
- **Report date:** 2026-02-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1197-2026

## Citation

> AI Analytics. FDA recall Z-1197-2026. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1197-2026. Source: US FDA. Licensed CC0.

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