- 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 SKU DYNJRA1555: UDI/DI 10193489238723 each, 40193489238724 case, Lot Numbers: 25CLA724; Medline SKU DYNJRA1555: UDI/DI 10193489238723 each, 40193489238724 case, Lot Numbers: 25CLA306; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMH667; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMC856; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMA370; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25IMI402; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25HME985; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25AMI063; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 24JMI488; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 24JMA113; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 23KMD776; Medline SKU DYNJRA1920: UDI/DI 10195327111168 each, 40195327111169 case, Lot Numbers: 25FBQ144; Medline SKU DYNJRA2013: UDI/DI 10195327212049 each, 40195327212040 case, Lot Numbers: 26ABV382; Medline SKU DYNJRA2013: UDI/DI 10195327212049 each, 40195327212040 case, Lot Numbers: 24GBA206; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 26BMJ305; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25LMA710; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25JMI170; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25JMA642; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25GMH968; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25EMJ739; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25DMF107; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25DMB676; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 24HMD119; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 24DMB563; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 23IBL595; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 23GBO103; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 25EMJ740; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 25EMB776; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 25DMH562; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 25DMD631; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24JMA116; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24FMI984; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24EMC757; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24CMH743; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24BBP785; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 23HBQ128; Medline SKU DYNJRA2067A: UDI/DI 10198459371967 each, 40198459371968 case, Lot Numbers: 26BBJ400; Medline SKU DYNJRA2093: UDI/DI 10195327296797 each, 40195327296798 case, Lot Numbers: 23JBQ988; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 26BMC993; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 26AMF175
- Units affected
- 28106 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-2232-2026
- 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