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Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN TRAY, Medline Kit SKU DYNJRA1555; 2) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1817; 3) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA1920; 4) ULTRASOUND GUIDED NERVE BLOCK, Medline Kit SKU DYNJRA2013; 5) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2017; 6) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067; 7) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067A; 8) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2093; 9) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2117A; 10) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124; 11) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124A; 12) PAIN TRAY, Medline Kit SKU DYNJRA2144; 13) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2221; 14) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2333; 15) SPINAL TRAY, Medline Kit SKU DYNJRA2390; 16) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2402; 17) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407; 18) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407A; 19) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407B; 20) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447; 21) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447A; 22) SPINAL TRAY 25G, Medline Kit SKU DYNJRA2488A; 23) J&S SPINAL TRAY, Medline Kit SKU DYNJRA2545; 24) SPINAL TRAY, Medline Kit SKU DYNJRA2549; 25) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2550; 26) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2552; 27) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554; 28) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554A; 29) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2578; 30) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2588; 31) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2602; 32) SPINAL TRAY, Medline Kit SKU DYNJRA2618; 33) SPINAL TRAY,

Class I
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
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