MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; ...
FDA Device Recall #Z-2488-2026 - Class II, May 4, 2026
Recall Summary
| Recall Number | Z-2488-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | May 4, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 1248 units |
Product Description
MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Medline Kit Number/SKU DYNJ31204D; 3) KIT PERIPHERAL VASCULAR MMC, Medline Kit Number/SKU DYNJ905368D; 4) KIT PERIVASCULAR MMC, Medline Kit Number/SKU DYNJ905368B; 5) VP SHUNT PACK, Medline Kit Number/SKU DYNJ46530I.
Reason for Recall
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Lot / Code Information
Medline Kit Number/SKU DYNJ912271: UDI/DI 10198459688324 (each), 40198459688325 (case), Lot Number 26CBQ109; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 25FBO720; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBO387; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBO015; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBD819; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBA736; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24FBG144; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24DBO838; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24BBC453; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24ABM118; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 23KBS950; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 23IBC670; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22LBN883; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22KBF121; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22IBN293; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22FBO695; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22OBH349; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 21JBY498; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 21JBY507; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 21JBH105; Medline Kit Number/SKU DYNJ905368D: UDI/DI 10198459698149 (each), 40198459698140 (case), Lot Number 26DBE022; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25GBD045; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25EBN367; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25CBR397; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25BBK435; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25ABR151; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24JBU152; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24IBD106; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24HBI890; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24GBS879; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24EBB182; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24CBT638; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24CBN624; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23KBU577; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23IBS119; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23GBV028; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23HBO351; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23BBL739; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23BBL740; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23ABS355; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23ABG430; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22GBG375; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22GBG376; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22GBG377; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22EBM264; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22EBL230; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 21LBV309; Medline Kit Number/SKU DYNJ46530I: UDI/DI 10193489338843 (each), 40193489338844 (case), Lot Number 21IMB152; Medline Kit Number/SKU DYNJ46530I: UDI/DI 10193489338843 (each), 40193489338844 (case), Lot Number 21HMD185; Medline Kit Number/SKU DYNJ46530I: UDI/DI 10193489338843 (each), 40193489338844 (case), Lot Number 21DMA957; Medline Kit Number/SKU DYNJ46530I: UDI/DI 10193489338843 (each), 40193489338844 (case), Lot Number 21BME627; Medline Kit Number/SKU DYNJ46530I: UDI/DI 10193489338843 (each), 40193489338844 (case), Lot Number 21BMC286.
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2790-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2788-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2791-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2789-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2737-2026 | Class II | Medline Kits containing Zimmer Biomet mixing bo... | Jun 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.