Class II U.S. Food and Drug Administration

Medline medical procedure convenience kits labeled as: 1) Watkins Spine 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

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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-1200-2026
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
117 units
Distribution
Nationwide
Made in
United States
Lot / code info
Medline Kit SKU DYNJ0275635M: UDI/DI 10198459464799 (EA) 40198459464790 (CS), Lot Number 25KMH120; Medline Kit SKU DYNJ0395037X: UDI/DI 10198459600555 (EA) 40198459600556 (CS), Lot Number 25LMB119; Medline Kit SKU DYNJ04809N: UDI/DI 10198459440908 (EA) 40198459440909 (CS), Lot Number 25KMF969; Medline Kit SKU DYNJ0565499AN: UDI/DI 10195327318352 (EA) 40195327318353 (CS), Lot Number 25JMF339; Medline Kit SKU DYNJ0565499AN: UDI/DI 10195327318352 (EA) 40195327318353 (CS), Lot Number 25LMB019; Medline Kit SKU DYNJ27164Q: UDI/DI 10198459138102 (EA) 40198459138103 (CS), Lot Number 25KMJ742; Medline Kit SKU DYNJ40221G: UDI/DI 10198459448515 (EA) 40198459448516 (CS), Lot Number 25KME669; Medline Kit SKU DYNJ45311J: UDI/DI 10198459255670 (EA) 40198459255671 (CS), Lot Number 25KMI080; Medline Kit SKU DYNJ46330C: UDI/DI 10889942490066 (EA) 40889942490067 (CS), Lot Number 25KMD795; Medline Kit SKU DYNJ48980M: UDI/DI 10195327533694 (EA) 40195327533695 (CS), Lot Number 25KMC459; Medline Kit SKU DYNJ52995F: UDI/DI 10195327639778 (EA) 40195327639779 (CS), Lot Number 25KME064; Medline Kit SKU DYNJ56483L: UDI/DI 10195327518141 (EA) 40195327518142 (CS), Lot Number 25LMB049; Medline Kit SKU DYNJ61200B: UDI/DI 10195327604264 (EA) 40195327604265 (CS), Lot Number 25KBE867; Medline Kit SKU DYNJ66150: UDI/DI 10193489317558 (EA) 40193489317559 (CS), Lot Number 25KMC057; Medline Kit SKU DYNJ66630: UDI/DI 10193489368284 (EA) 40193489368285 (CS), Lot Number 25KMG435; Medline Kit SKU DYNJ69065F: UDI/DI 10198459226618 (EA) 40198459226619 (CS), Lot Number 25KMI293; Medline Kit SKU DYNJ69113C: UDI/DI 10198459170225 (EA) 40198459170226 (CS), Lot Number 25JMJ726; Medline Kit SKU DYNJ69401D: UDI/DI 10198459183676 (EA) 40198459183677 (CS), Lot Number 25KMJ106; Medline Kit SKU DYNJ81013D: UDI/DI 10198459547706 (EA) 40198459547707 (CS), Lot Number 25LDA122; Medline Kit SKU DYNJ84275A: UDI/DI 10198459240171 (EA) 40198459240172 (CS), Lot Number 25LMB546; Medline Kit SKU DYNJ88971: UDI/DI 10198459222269 (EA) 40198459222260 (CS), Lot Number 25KMH340; Medline Kit SKU DYNJ89943: UDI/DI 10198459299483 (EA) 40198459299484 (CS), Lot Number 25KMB583; Medline Kit SKU DYNJ900173J: UDI/DI 10198459292170 (EA) 40198459292171 (CS), Lot Number 25JDB487; Medline Kit SKU DYNJ904945G: UDI/DI 10198459518317 (EA) 40198459518318 (CS), Lot Number 25LBC198; Medline Kit SKU DYNJ909505D: UDI/DI 10198459594229 (EA) 40198459594220 (CS), Lot Number 25LMB637; Medline Kit SKU DYNJ910543F: UDI/DI 10198459554971 (EA) 40198459554972 (CS), Lot Number 25KMH376; Medline Kit SKU DYNJ910543G: UDI/DI 10198459588204 (EA) 40198459588205 (CS), Lot Number 25LMA619; Medline Kit SKU DYNJT4724: UDI/DI 10198459457913 (EA) 40198459457914 (CS), Lot Number 25KMI923; Medline Kit SKU DYNJT5184: UDI/DI 10198459467592 (EA) 40198459467593 (CS), Lot Number 25KMG240.
UPC codes
10198459464799, 40198459464790, 10198459600555, 40198459600556, 10198459440908, 40198459440909, 10195327318352, 40195327318353, 10198459138102, 40198459138103, 10198459448515, 40198459448516, 10198459255670, 40198459255671, 10889942490066, 40889942490067, 10195327533694, 40195327533695, 10195327639778, 40195327639779

Products covered by this recall

Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU DYNJ0395037X; 3) TOTAL HIP PACK, Kit SKU DYNJ04809N; 4) MAIN/LAMINECTOMY PACK-LF, Kit SKU DYNJ0565499AN; 5) SCC/SPOC HAND & FOOT PACK, Kit SKU DYNJ27164Q; 6) ORTHO SPINE, Kit SKU DYNJ40221G; 7) URO GYN PACK, Kit SKU DYNJ45311J; 8) LAMINECTOMY PACK, Kit SKU DYNJ46330C; 9) DJ ORTHO SPINE, Kit SKU DYNJ48980M; 10) CERVICAL PACK, Kit SKU DYNJ52995F; 11) NORTH BACK FUSION PACK-LF, Kit SKU DYNJ56483L; 12) KNEE ARTHROSCOPY CHRISTUS, Kit SKU DYNJ61200B; 13) KNEE ARTHROSCOPY PACK-LF, Kit SKU DYNJ66150; 14) HIP PACK, Kit SKU DYNJ66630; 15) OHNS FREE FLAP A PACK, Kit SKU DYNJ69065F; 16) LUMBAR PACK, Kit SKU DYNJ69113C; 17) LAMINECTOMY PACK, Kit SKU DYNJ69401D; 18) LAMINECTOMY PACK, Kit SKU DYNJ81013D; 19) HIP/SHOULDER ARTHROSCOPY PACK, Kit SKU DYNJ84275A; 20) FLASC ACL PACK, Kit SKU DYNJ88971; 21) SPINE PACK MERCY GALENA, Kit SKU DYNJ89943; 22) SPINAL FUSION MT CARMEL, Kit SKU DYNJ900173J; 23) HAND, Kit SKU DYNJ904945G; 24) LAMINECTOMY, Kit SKU DYNJ909505D; 25) SHOULDER SPLIT, Kit SKU DYNJ910543F; 26) SHOULDER SPLIT, Kit SKU DYNJ910543G; 27) CRANIOTOMY PACK, Kit SKU DYNJT4724; 28) SPINE PACK, Kit SKU DYNJT5184.

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.

  • 10198459464799
  • 40198459464790
  • 10198459600555
  • 40198459600556
  • 10198459440908
  • 40198459440909
  • 10195327318352
  • 40195327318353
  • 10198459138102
  • 40198459138103
  • 10198459448515
  • 40198459448516
  • 10198459255670
  • 40198459255671
  • 10889942490066
  • 40889942490067
  • 10195327533694
  • 40195327533695
  • 10195327639778
  • 40195327639779

Lot or batch code

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

  • 25KMH120
  • 25LMB119
  • 25KMF969
  • 25JMF339
  • 25LMB019
  • 25KMJ742
  • 25KME669
  • 25KMI080
  • 25KMD795
  • 25KMC459
  • 25KME064
  • 25LMB049
  • 25KBE867
  • 25KMC057
  • 25KMG435
  • 25KMI293
  • 25JMJ726
  • 25KMJ106
  • 25LDA122
  • 25LMB546

Model or item number

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

  • DYNJ0275635M
  • DYNJ0395037X
  • DYNJ04809N
  • DYNJ0565499AN
  • DYNJ27164Q
  • DYNJ40221G
  • DYNJ45311J
  • DYNJ46330C
  • DYNJ48980M
  • DYNJ52995F
  • DYNJ56483L
  • DYNJ61200B
  • DYNJ66150
  • DYNJ66630
  • DYNJ69065F
  • DYNJ69113C
  • DYNJ69401D
  • DYNJ81013D
  • DYNJ84275A
  • DYNJ88971

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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 10198459464799, 40198459464790, 10198459600555; lot code 25KMH120, 25LMB119, 25KMF969; model number DYNJ0275635M, DYNJ0395037X, DYNJ04809N. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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