Class II U.S. Food and Drug Administration

Medline medical procedure convenience kits labeled as: 1) SMJ LAP Chole recall: Medline kits were manufactured and distributed containing MASTISOL liquid

Recall published 9 months ago

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 hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1191-2026
Published
February 4, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
456 units
Distribution
Nationwide
Made in
United States
Lot / code info
Medline Kit SKU DYNJ19974P: UDI/DI 10198459138195 (EA) 40198459138196 (CS), Lot Number 25KMB830; Medline Kit SKU DYNJ19974P: UDI/DI 10198459138195 (EA) 40198459138196 (CS), Lot Number 25KMB831; Medline Kit SKU DYNJ20027K: UDI/DI 10198459228957 (EA) 40198459228958 (CS), Lot Number 25KMG395; Medline Kit SKU DYNJ20027K: UDI/DI 10198459228957 (EA) 40198459228958 (CS), 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; Medline Kit SKU DYNJ46939Q: UDI/DI 10198459404047 (EA) 40198459404048 (CS), Lot Number 25LDA059; Medline Kit SKU DYNJ49688C: UDI/DI 10198459155017 (EA) 40198459155018 (CS), Lot Number 25KMG180; Medline Kit SKU DYNJ51347N: UDI/DI 10198459386428 (EA) 40198459386429 (CS), Lot Number 25JBW506; Medline Kit SKU DYNJ54081F: UDI/DI 10198459172410 (EA) 40198459172411 (CS), Lot Number 25KMB295; Medline Kit SKU DYNJ58864B: UDI/DI 10198459346965 (EA) 40198459346966 (CS), Lot Number 25JBW678; Medline Kit SKU DYNJ59313B: UDI/DI 10195327248338 (EA) 40195327248339 (CS), Lot Number 25JMJ736; Medline Kit SKU DYNJ61095F: UDI/DI 10198459228568 (EA) 40198459228569 (CS), Lot Number 25KMC402; Medline Kit SKU DYNJ62065A: UDI/DI 10193489273472 (EA) 40193489273473 (CS), Lot Number 25KMI773; Medline Kit SKU DYNJ64174A: UDI/DI 10198459076367 (EA) 40198459076368 (CS), Lot Number 25LMB281; Medline Kit SKU DYNJ64258I: UDI/DI 10198459031564 (EA) 40198459031565 (CS), Lot Number 25KMJ665; Medline Kit SKU DYNJ64786D: UDI/DI 10198459328671 (EA) 40198459328672 (CS), Lot Number 25JMJ978; Medline Kit SKU DYNJ67686B: UDI/DI 10198459383120 (EA) 40198459383121 (CS), Lot Number 25KMH683; Medline Kit SKU DYNJ69142F: UDI/DI 10198459478499 (EA) 40198459478490 (CS), Lot Number 25KMH891; Medline Kit SKU DYNJ81695B: UDI/DI 10198459023453 (EA) 40198459023454 (CS), Lot Number 25KMB850; Medline Kit SKU DYNJ900901K: UDI/DI 10198459272493 (EA) 40198459272494 (CS), Lot Number 25KBP907; Medline Kit SKU DYNJ900906L: UDI/DI 10198459408526 (EA) 40198459408527 (CS), Lot Number 25LMA386; Medline Kit SKU DYNJ906861D: UDI/DI 10198459293702 (EA) 40198459293703 (CS), Lot Number 25LMA703; Medline Kit SKU DYNJ907087C: UDI/DI 10198459201301 (EA) 40198459201302 (CS), Lot Number 25KMJ480; Medline Kit SKU DYNJ911116A: UDI/DI 10198459354274 (EA) 40198459354275 (CS), Lot Number 25KMH214; Medline Kit SKU DYNJ911116A: UDI/DI 10198459354274 (EA) 40198459354275 (CS), Lot Number 25KMJ766; Medline Kit SKU DYNJT3884: UDI/DI 10198459366840 (EA) 40198459366841 (CS), Lot Number 25JBX326; Medline Kit SKU DYNJT4504: UDI/DI 10198459456701 (EA) 40198459456702 (CS), Lot Number 25KMF188; Medline Kit SKU PHS109062D: UDI/DI 10889942716548 (EA) 40889942716549 (CS), Lot Number 25KMD005.
UPC codes
10198459138195, 40198459138196, 10198459228957, 40198459228958, 10195327024338, 40195327024339, 10198459138218, 40198459138219, 10198459603655, 40198459603656, 10195327037369, 40195327037360, 10198459257131, 40198459257132, 10193489806694, 40193489806695, 10198459404047, 40198459404048, 10198459155017, 40198459155018

Products covered by this recall

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, Kit SKU DYNJ25763O; 6) BWNBORO LAP CHOLE PACK-LF, Kit SKU DYNJ32836B; 7) MINOR SET UP PACK, Kit SKU DYNJ43272K; 8) PK, GEN LAPAROSCOPIC CHOLE, Kit SKU DYNJ43976C; 9) GV LAP CHOLE PACK, Kit SKU DYNJ46939Q; 10) LAP CHOLE PACK, Kit SKU DYNJ49688C; 11) GENERAL ROBOTIC LAP, Kit SKU DYNJ51347N; 12) LAP CHOLE PACK, Kit SKU DYNJ54081F; 13) PEDIATRIC MOSES, Kit SKU DYNJ58864B; 14) LAPAROTOMY PACK, Kit SKU DYNJ59313B; 15) CRMC LAP CHOLE DIAG LAP-LF, Kit SKU DYNJ61095F; 16) LAP GASTRIC PACK, Kit SKU DYNJ62065A; 17) MINOR PACK, Kit SKU DYNJ64174A; 18) GENERAL SURGERY PACK, Kit SKU DYNJ64258I; 19) GENERAL LAP SHARED-LF, Kit SKU DYNJ64786D; 20) CHOLE PACK, Kit SKU DYNJ67686B; 21) GEN SURG MINOR PACK, Kit SKU DYNJ69142F; 22) LAP CHOLE PACK, Kit SKU DYNJ81695B; 23) GENERAL LAPAROSCOPY, Kit SKU DYNJ900901K; 24) GEN MINOR, Kit SKU DYNJ900906L; 25) ROBOTIC GENERAL, Kit SKU DYNJ906861D; 26) RMC GENERAL LAPAROSCOPIC, Kit SKU DYNJ907087C; 27) LAP CHOLE LMC CDS, Kit SKU DYNJ911116A; 28) MINOR GENERAL PACK, Kit SKU DYNJT3884; 29) GENERAL LAPAROSCOPY PACK, Kit SKU DYNJT4504; 30) MINOR SURGERY PACK-LF, Kit SKU PHS109062D.

Check your product

The notice names 60 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10198459138195
  • 40198459138196
  • 10198459228957
  • 40198459228958
  • 10195327024338
  • 40195327024339
  • 10198459138218
  • 40198459138219
  • 10198459603655
  • 40198459603656
  • 10195327037369
  • 40195327037360
  • 10198459257131
  • 40198459257132
  • 10193489806694
  • 40193489806695
  • 10198459404047
  • 40198459404048
  • 10198459155017
  • 40198459155018

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25KMB830
  • 25KMB831
  • 25KMG395
  • 25KMH132
  • 25KMF540
  • 25KMH134
  • 25KMI209
  • 25KBF167
  • 25KME892
  • 25KMG962
  • 25JDA437
  • 25LDA059
  • 25KMG180
  • 25JBW506
  • 25KMB295
  • 25JBW678
  • 25JMJ736
  • 25KMC402
  • 25KMI773
  • 25LMB281

Model or item number

On the rating label, the box or the instruction sheet.

  • DYNJ19974P
  • DYNJ20027K
  • DYNJ20468J
  • DYNJ25763N
  • DYNJ25763O
  • DYNJ32836B
  • DYNJ43272K
  • DYNJ43976C
  • DYNJ46939Q
  • DYNJ49688C
  • DYNJ51347N
  • DYNJ54081F
  • DYNJ58864B
  • DYNJ59313B
  • DYNJ61095F
  • DYNJ62065A
  • DYNJ64174A
  • DYNJ64258I
  • DYNJ64786D
  • DYNJ67686B

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10198459138195, 40198459138196, 10198459228957; lot code 25KMB830, 25KMB831, 25KMG395; model number DYNJ19974P, DYNJ20027K, DYNJ20468J. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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