FDA Device recall Z-1197-2026
Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O
- FDA Device
- Class II
- ongoing
- Published 2026-02-04
On 2026-02-04 the FDA classified a Class II recall of Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O by Medline Industries, citing 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 vi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1197-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-12 |
| Published | 2026-02-04 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
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
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.
Identifiers
| code_info | Medline Kit SKU DYNJ0395022O: UDI/DI 10195327634827 (EA) 40195327634828 (CS), Lot Number 25KME682; Medline Kit SKU DY…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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1197-2026%22
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