Medline Industries, LP recalls Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- Lot #
- 25KMH120; Medline Kit SKU DYNJ0395037X: UDI/DI 10198459600555 (EA) 40198459600556 (CS)
- Lot #
- 25LMB119; Medline Kit SKU DYNJ04809N: UDI/DI 10198459440908 (EA) 40198459440909 (CS)
- Lot #
- 25KMF969; Medline Kit SKU DYNJ0565499AN: UDI/DI 10195327318352 (EA) 40195327318353 (CS)
- Lot #
- 25JMF339; Medline Kit SKU DYNJ0565499AN: UDI/DI 10195327318352 (EA) 40195327318353 (CS)
- Lot #
- 25LMB019; Medline Kit SKU DYNJ27164Q: UDI/DI 10198459138102 (EA) 40198459138103 (CS)
- Lot #
- 25KMJ742; Medline Kit SKU DYNJ40221G: UDI/DI 10198459448515 (EA) 40198459448516 (CS)
- Lot #
- 25KME669; Medline Kit SKU DYNJ45311J: UDI/DI 10198459255670 (EA) 40198459255671 (CS)
- Lot #
- 25KMI080; Medline Kit SKU DYNJ46330C: UDI/DI 10889942490066 (EA) 40889942490067 (CS)
- Lot #
- 25KMD795; Medline Kit SKU DYNJ48980M: UDI/DI 10195327533694 (EA) 40195327533695 (CS)
- Lot #
- 25KMC459; Medline Kit SKU DYNJ52995F: UDI/DI 10195327639778 (EA) 40195327639779 (CS)
- Lot #
- 25KME064; Medline Kit SKU DYNJ56483L: UDI/DI 10195327518141 (EA) 40195327518142 (CS)
- Lot #
- 25LMB049; Medline Kit SKU DYNJ61200B: UDI/DI 10195327604264 (EA) 40195327604265 (CS)
- Lot #
- 25KBE867; Medline Kit SKU DYNJ66150: UDI/DI 10193489317558 (EA) 40193489317559 (CS)
- Lot #
- 25KMC057; Medline Kit SKU DYNJ66630: UDI/DI 10193489368284 (EA) 40193489368285 (CS)
- Lot #
- 25KMG435; Medline Kit SKU DYNJ69065F: UDI/DI 10198459226618 (EA) 40198459226619 (CS)
- Lot #
- 25KMI293; Medline Kit SKU DYNJ69113C: UDI/DI 10198459170225 (EA) 40198459170226 (CS)
- Lot #
- 25JMJ726; Medline Kit SKU DYNJ69401D: UDI/DI 10198459183676 (EA) 40198459183677 (CS)
- Lot #
- 25KMJ106; Medline Kit SKU DYNJ81013D: UDI/DI 10198459547706 (EA) 40198459547707 (CS)
- Lot #
- 25LDA122; Medline Kit SKU DYNJ84275A: UDI/DI 10198459240171 (EA) 40198459240172 (CS)
- Lot #
- 25LMB546; Medline Kit SKU DYNJ88971: UDI/DI 10198459222269 (EA) 40198459222260 (CS)
- Lot #
- 25KMH340; Medline Kit SKU DYNJ89943: UDI/DI 10198459299483 (EA) 40198459299484 (CS)
- Lot #
- 25KMB583; Medline Kit SKU DYNJ900173J: UDI/DI 10198459292170 (EA) 40198459292171 (CS)
- Lot #
- 25JDB487; Medline Kit SKU DYNJ904945G: UDI/DI 10198459518317 (EA) 40198459518318 (CS)
- Lot #
- 25LBC198; Medline Kit SKU DYNJ909505D: UDI/DI 10198459594229 (EA) 40198459594220 (CS)
- Lot #
- 25LMB637; Medline Kit SKU DYNJ910543F: UDI/DI 10198459554971 (EA) 40198459554972 (CS)
- Lot #
- 25KMH376; Medline Kit SKU DYNJ910543G: UDI/DI 10198459588204 (EA) 40198459588205 (CS)
- Lot #
- 25LMA619; Medline Kit SKU DYNJT4724: UDI/DI 10198459457913 (EA) 40198459457914 (CS)
- Lot #
- 25KMI923; Medline Kit SKU DYNJT5184: UDI/DI 10198459467592 (EA) 40198459467593 (CS)
- Lot #
- 25KMG240
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What the firm 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 recalls@medline.com.
DistributionShow detailsHide
US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1200-2026
- FDA device classification · OJHOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4800The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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