- Recalling firm
- Medline Industries, LP
- 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.
- Affected products (lot / model / serial)
- Medline Kit SKU DYNJRA9026: UDI/DI 10884389285688 each, 40884389285689, case, Lot Numbers: 26BBD235, 26ABB534, 25DBT837, 25CBH118, 24FBT403, 24FBJ505.
- Units affected
- 4370 kits
- Distribution pattern
- Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2235-2026
- Recall initiated
- April 10, 2026
- FDA classification date
- May 28, 2026
- FDA report date
- June 3, 2026
- FDA event ID
- 98837
- Last updated on HTM Vibe
- July 24, 2026