| | 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-2233-2026 |
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| Recall Event ID |
98837 |
| Product Classification |
Epidural anesthesia kit - Product Code OGE
|
| Product | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as:
1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245;
2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555;
3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A;
4) SPINAL TRAY, Medline Kit SKU DYNJRA0978A;
5) TRAY, SPINAL, WHIT 24GX4, Medline Kit SKU DYNJRA1034;
6) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA9028;
7) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA9030. |
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| Code Information |
Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 26AMH714;
Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 26AMF179;
Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 25IMI476;
Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 25GME934;
Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 24JMA156;
Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 24IMG162;
Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23IBG784;
Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23HBG512;
Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23HBA325;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 26AMK307;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25LME383;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25JMJ632;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25IMI508;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25IMB093;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25GMB270;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25EMD040;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25EMB958;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24HMD548;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24HMA551;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24GMI471;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24DBA515;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24BBQ043;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 23IBH382;
Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 23GBD403;
Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 26BMH362;
Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25LMC760;
Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25JME361;
Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25IMI413;
Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25HMH140;
Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25HMA304;
Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25GMB268;
Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25FMF696;
Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25DMJ266;
Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24HMB245;
Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24HMB241;
Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24GMB114;
Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24BME560;
Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25KMD376;
Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25JMC383;
Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25FMH538;
Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 24KDB290;
Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 24EDB889;
Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 23JDC308;
Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 26ABW292;
Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25KBT852;
Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25JBR203;
Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25HBS729;
Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25HBJ284;
Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25EBD163;
Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 24EDB670;
Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 24CDA047;
Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 24BDA117;
Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 23JDB931;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26BBN630;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26BBN631;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABU477;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABU479;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABQ765;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABE062;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABE063;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25DBE494;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25DBE495;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25DBE493;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25BBC565;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 24BBP041;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 23HBS638;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 23HBS639;
Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 23GBC535;
Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 26ABQ980;
Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 26ABJ386;
Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25LBH067;
Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25KBR359;
Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25JBP383;
Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25IBK145;
Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25ABP041;
Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24GBD227;
Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24FBJ511;
Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24FBJ026;
Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24BBP046;
Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 23IBG977;
Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 23GBM182. |
| FEI Number |
1417592
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Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
|
| 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 | 41720 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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