The Recall Desk
HighFDA (Devices)·Z-1191-2026·Announced 2026-02-04

[pending] Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ1997

Pending LLM rewrite. Source: FDA_DEVICE Z-1191-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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 recalled product

Product
Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K; 3) LAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J; 4) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N; 5) SMJ LAPAROSCOPY PACK,
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices

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 (20)

  • Medline Kit SKU DYNJ19974P: UDI/DI 10198459138195 (EA) 40198459138196 (CS)
  • Lot Number 25KMB830
  • Lot Number 25KMB831
  • Medline Kit SKU DYNJ20027K: UDI/DI 10198459228957 (EA) 40198459228958 (CS)
  • Lot Number 25KMG395
  • Lot Number 25KMH132
  • Medline Kit SKU DYNJ20468J: UDI/DI 10195327024338 (EA) 40195327024339 (CS)
  • Lot Number 25KMF540
  • Medline Kit SKU DYNJ25763N: UDI/DI 10198459138218 (EA) 40198459138219 (CS)
  • Lot Number 25KMH134
  • Medline Kit SKU DYNJ25763O: UDI/DI 10198459603655 (EA) 40198459603656 (CS)
  • Lot Number 25KMI209
  • Medline Kit SKU DYNJ32836B: UDI/DI 10195327037369 (EA) 40195327037360 (CS)
  • Lot Number 25KBF167
  • Medline Kit SKU DYNJ43272K: UDI/DI 10198459257131 (EA) 40198459257132 (CS)
  • Lot Number 25KME892
  • Medline Kit SKU DYNJ43976C: UDI/DI 10193489806694 (EA) 40193489806695 (CS)
  • Lot Number 25KMG962
  • Medline Kit SKU DYNJ46939Q: UDI/DI 10198459404047 (EA) 40198459404048 (CS)
  • Lot Number 25JDA437

Distribution

Distributed nationwide across the United States.

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