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Medline medical procedure convenience kits labeled as recallZ-1200-2026 · Medline Industries, LP · initiated Dec 12, 2025

Class II Open, Classified All recalls posted in January 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Medline Industries issued a URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/12/2025 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-25-251-FGX2 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-1200-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Dec 12, 2025
Posted by the FDA
Jan 28, 2026
Recalling firm
Medline Industries, LP
Quantity
117 units
Product code
OJH
Distribution
US Nationwide distribution.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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.

Devices named in this recall

20 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 98226).

Sources and updates

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