Z-2235-2026 Class I Ongoing
FDA device recall Z-2235-2026 was initiated by Medline Industries, LP on April 10, 2026 and is designated Class I. 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 integrit… The recall status is ongoing. Affected quantity: 4370 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2026
- Initiation Date
- April 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4370 kits
Product Description
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026
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.
Code Information
Medline Kit SKU DYNJRA9026: UDI/DI 10884389285688 each, 40884389285689, case, Lot Numbers: 26BBD235, 26ABB534, 25DBT837, 25CBH118, 24FBT403, 24FBJ505.