Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ...
FDA Device Recall #Z-2236-2026 - Class I, April 10, 2026
Recall Summary
| Recall Number | Z-2236-2026 |
| Classification | Class I - Serious risk |
| Date Initiated | April 10, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 30120 kits |
Product Description
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097; 2) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1154; 3) SPINAL TRAY, Medline Kit SKU DYNJRA1192A; 4) BLOCK TRAY, Medline Kit SKU DYNJRA1212; 5) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1285; 6) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA9031; 7) SPINAL BLOCK TRAY 25G WHITACRE, Medline Kit SKU DYNJRA9032; 8) 25G SPINAL TRAY, Medline Kit SKU PAIN1239.
Reason for Recall
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Distribution Pattern
Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
Lot / Code Information
Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26BBJ392; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26ABS354; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25LBC413; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25IBK142; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25FBD584; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25BBK828; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 24FBT398; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 24BBR608; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23JBB581; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23IBQ010; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23HBM569; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 26AMK346; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25KMG102; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25JMA641; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25GMC349; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25DMG474; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25DMC357; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25ADB659; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 24LDB606; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 24KDB682; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 24JDC049; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 24FDA638; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 23JDC468; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 26BBJ394; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25LBR313; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25KBP760; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25JBV827; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25JBG134; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25HBK390; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25DBF619; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 26BBT340; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 26ABU446; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25JBE914; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25GBT022; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25EBS286; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25DBJ529; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25ADA237; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24JDB280; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24FDA639; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24EDB329; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24DDB935; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24BDA655; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 26ABG845; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 25LBI115; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 25IBP109; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 25EBE523; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 24LDA129; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 24KDB674; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 24FDA633; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 23JDC158; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 26ABC785; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 25LBH049; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 25KBK340; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 25BBH830; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 25BBF629; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 24GBD224; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 24FBJ060; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 23IBQ015; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 23HBR199; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 23GBR079; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25KBJ715; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25JBP382; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25JBB437; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25GBH340; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25FBD726; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25ABP028; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 26CBD939; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 26BBB061; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 25LBT244; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 25FBU644; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 24DLA279.
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.