Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ1...
FDA Device Recall #Z-1191-2026 — Class II — December 12, 2025
Recall Summary
| Recall Number | Z-1191-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 12, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 456 units |
Product Description
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.
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.
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
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.
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2235-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2237-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2236-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2234-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2232-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.