| | Class 1 Device Recall Medline |  |
| Date Initiated by Firm | April 10, 2026 |
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| Date Posted | May 28, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2236-2026 |
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| Recall Event ID |
98837 |
| 510(K)Number | K213481 |
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| Product Classification |
General surgery tray - Product Code LRO
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| Product | 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. |
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| 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. |
| FEI Number |
1417592
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Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Haley Barclay
800-359-1704 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Component design/selection |
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| Action | Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 4/10/2026 via USPS first class mail and email. The notice explained the issue with the component and requested the following:
- Identify and quarantine the affected item and lot numbers (kit).
- Respond to notice via the portal: Website link: https://recalls.medline.com, Recall Reference #: R-26-065-FGX1, using the Recall Code provided.
- Once the response is received, over-labels will be provided to be placed on the affected inventory with instructions to remove and discard the affected component.
- Distributors or those who have further distributed the product are directed to notify those to whom the affected kits were distributed and include the 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. |
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| Quantity in Commerce | 30120 kits |
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| Distribution | Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LRO
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