- 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 DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 26ABG838; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 25JBR222; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 25IBJ307; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 25EBR346; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 24LDB145; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 24FDB896; Medline Kit SKU DYNJRA0143B: UDI/DI 10195327125820 each, 40195327125821 case, Lot Number 24ABQ670; Medline Kit SKU DYNJRA0205B: UDI/DI 10195327472344 each, 40195327472345 case, Lot Number 24KMD212; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 26CMG585; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 26BMK211; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 25JMC385; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 25IMB105; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 25EMC687; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 24HMD675; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 24HMB249; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 24GMH436; Medline Kit SKU DYNJRA0320: UDI/DI 10884389656778 each, 40884389656779 case, Lot Number 24EDB314; Medline Kit SKU DYNJRA0320: UDI/DI 10884389656778 each, 40884389656779 case, Lot Number 24BDA550; Medline Kit SKU DYNJRA0320A: UDI/DI 10198459027796 each, 40198459027797 case, Lot Number 26ABJ309; Medline Kit SKU DYNJRA0320A: UDI/DI 10198459027796 each, 40198459027797 case, Lot Number 25HBT750; Medline Kit SKU DYNJRA0320A: UDI/DI 10198459027796 each, 40198459027797 case, Lot Number 25GBW261; Medline Kit SKU DYNJRA0320A: UDI/DI 10198459027796 each, 40198459027797 case, Lot Number 25FBP025; Medline Kit SKU DYNJRA0413C: UDI/DI 10195327253363 each, 40195327253364 case, Lot Number 26AMK323; Medline Kit SKU DYNJRA0413C: UDI/DI 10195327253363 each, 40195327253364 case, Lot Number 25HMB655; Medline Kit SKU DYNJRA0413C: UDI/DI 10195327253363 each, 40195327253364 case, Lot Number 25FMF763; Medline Kit SKU DYNJRA0413C: UDI/DI 10195327253363 each, 40195327253364 case, Lot Number 24KMF380; Medline Kit SKU DYNJRA0413C: UDI/DI 10195327253363 each, 40195327253364 case, Lot Number 24KMA760; Medline Kit SKU DYNJRA0413C: UDI/DI 10195327253363 each, 40195327253364 case, Lot Number 23IBH412; Medline Kit SKU DYNJRA0461D: UDI/DI 10195327120689 each, 40195327120680 case, Lot Number 24KME483; Medline Kit SKU DYNJRA0461D: UDI/DI 10195327120689 each, 40195327120680 case, Lot Number 23KMD757; Medline Kit SKU DYNJRA0945: UDI/DI 10889942598267 each, 40889942598268 case, Lot Number 26BBP431; Medline Kit SKU DYNJRA0945: UDI/DI 10889942598267 each, 40889942598268 case, Lot Number 25KBN750; Medline Kit SKU DYNJRA0945: UDI/DI 10889942598267 each, 40889942598268 case, Lot Number 25IBK141; Medline Kit SKU DYNJRA0945: UDI/DI 10889942598267 each, 40889942598268 case, Lot Number 25EBG343; Medline Kit SKU DYNJRA0945: UDI/DI 10889942598267 each, 40889942598268 case, Lot Number 25ADA288; Medline Kit SKU DYNJRA0945: UDI/DI 10889942598267 each, 40889942598268 case, Lot Number 24FDA636; Medline Kit SKU DYNJRA1140B: UDI/DI 10193489432015 each, 40193489432016 case, Lot Number 26BMI341; Medline Kit SKU DYNJRA1140B: UDI/DI 10193489432015 each, 40193489432016 case, Lot Number 25LMF246; Medline Kit SKU DYNJRA1140B: UDI/DI 10193489432015 each, 40193489432016 case, Lot Number 25JMA359; Medline Kit SKU DYNJRA1140B: UDI/DI 10193489432015 each, 40193489432
- Units affected
- 200702 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-2237-2026
- 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