- 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 DYNJRA1181C: UDI/DI 10193489457605 each, 40193489457606 case, Lot Number 25DMF105; Medline Kit SKU DYNJRA1181C: UDI/DI 10193489457605 each, 40193489457606 case, Lot Number 25CMB575; Medline Kit SKU DYNJRA1860: UDI/DI 10195327008413 each, 40195327008414 case, Lot Number 24DMB099.
- Units affected
- 270 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-2234-2026
- 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