Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026
FDA Recall Z-2235-2026 · Posted 2026-05-28
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Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeOJH
Date Initiated2026-04-10
Product Quantity4370 kits
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.
Firm 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 [email protected].
Root Cause
Component design/selection
Distribution Pattern
Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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