Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU ...

FDA Device Recall #Z-1197-2026 — Class II — December 12, 2025

Recall Summary

Recall Number Z-1197-2026
Classification Class II — Moderate risk
Date Initiated December 12, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medline Industries, LP
Location Northfield, IL
Product Type Devices
Quantity 1,928 total

Product Description

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 Pattern

US Nationwide distribution.

Lot / Code Information

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.

Other Recalls from Medline Industries, LP

Recall # Classification Product Date
Z-2235-2026 Class I Medline kits containing Huons Co. Bupivacaine H... Apr 10, 2026
Z-2237-2026 Class I Medline kits containing Huons Co. Bupivacaine H... Apr 10, 2026
Z-2236-2026 Class I Medline kits containing Huons Co. Bupivacaine H... Apr 10, 2026
Z-2234-2026 Class I Medline kits containing Huons Co. Bupivacaine H... Apr 10, 2026
Z-2232-2026 Class I Medline kits containing Huons Co. Bupivacaine H... Apr 10, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.