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Class 1 Device Recall Medline

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 Class 1 Device Recall Medlinesee related information
Date Initiated by FirmApril 10, 2026
Date PostedMay 28, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2232-2026
Recall Event ID 98837
Product Classification Spinal epidural anesthesia kit - Product Code OFT
ProductMedline 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, Medline Kit SKU DYNJRA2619; 34) SPINAL TRAY, Medline Kit SKU DYNJRA2622; 35) SPINAL BLOCK 25 WHITACRE 5S ND, Medline Kit SKU DYNJRA2624; 36) SPINAL TRAY, Medline Kit SKU DYNJRA2631; 37) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2632; 38) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2633; 39) SPINAL TRAY, Medline Kit SKU DYNJRA2645; 40) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2654; 41) CSE PAIN MANAGEMENT TRAY, Medline Kit SKU DYNJRA2665; 42) SPINAL TRAY, Medline Kit SKU DYNJRA2667; 43) SPINAL TRAY 24G BD, Medline Kit SKU DYNJRA2675; 44) SPINAL TRAY W/ CHLORAPREP, Medline Kit SKU DYNJRA2680; 45) SPINAL TRAY, Medline Kit SKU DYNJRA2682; 46) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2684; 47) SPINAL TRAY, Medline Kit SKU DYNJRA2725; 48) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2757; 49) TRAY, 25G SPINAL W/RX DURAPREP, Medline Kit SKU DYNJRA9039; 50) TRAY, 25G SPINAL W/RX, Medline Kit SKU DYNJRA9045; 51) SLSYSTEM CSE TRAY, Medline Kit SKU PAIN2333; 52) 25G SPINAL BLOCK TRAY, Medline Kit SKU SAMPA0135.
Code Information 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; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 25LMG019; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 25JME838; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 25FMD398; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 25DMH259; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 25BMJ032; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 24KMH222; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 24JMB172; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 24HME068; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 24HMA876; Medline SKU DYNJRA2124: UDI/DI 10195327332334 each, 40195327332335 case, Lot Numbers: 25KBT829; Medline SKU DYNJRA2124: UDI/DI 10195327332334 each, 40195327332335 case, Lot Numbers: 25HBU514; Medline SKU DYNJRA2124: UDI/DI 10195327332334 each, 40195327332335 case, Lot Numbers: 25FBB363; Medline SKU DYNJRA2124: UDI/DI 10195327332334 each, 40195327332335 case, Lot Numbers: 24FBT394; Medline SKU DYNJRA2124: UDI/DI 10195327332334 each, 40195327332335 case, Lot Numbers: 23HBE118; Medline SKU DYNJRA2124A: UDI/DI 10198459699856 each, 40198459699857 case, Lot Numbers: 26CBD127; Medline SKU DYNJRA2144: UDI/DI 10195327356255 each, 40195327356256 case, Lot Numbers: 23IBP002; Medline SKU DYNJRA2221: UDI/DI 10195327428174 each, 40195327428175 case, Lot Numbers: 25KMC852; Medline SKU DYNJRA2221: UDI/DI 10195327428174 each, 40195327428175 case, Lot Numbers: 25IMI404; Medline SKU DYNJRA2221: UDI/DI 10195327428174 each, 40195327428175 case, Lot Numbers: 25EMJ886; Medline SKU DYNJRA2221: UDI/DI 10195327428174 each, 40195327428175 case, Lot Numbers: 25DMF094; Medline SKU DYNJRA2221: UDI/DI 10195327428174 each, 40195327428175 case, Lot Numbers: 24JMA125; Medline SKU DYNJRA2221: UDI/DI 10195327428174 each, 40195327428175 case, Lot Numbers: 23HBX509; Medline SKU DYNJRA2333: UDI/DI 10195327572686 each, 40195327572687 case, Lot Numbers: 26BBH475; Medline SKU DYNJRA2333: UDI/DI 10195327572686 each, 40195327572687 case, Lot Numbers: 26BBB092; Medline SKU DYNJRA2333: UDI/DI 10195327572686 each, 40195327572687 case, Lot Numbers: 26ABQ762; Medline SKU DYNJRA2333: UDI/DI 10195327572686 each, 40195327572687 case, Lot Numbers: 25LBA381; Medline SKU DYNJRA2333: UDI/DI 10195327572686 each, 40195327572687 case, Lot Numbers: 25IBJ314; Medline SKU DYNJRA2390: UDI/DI 10195327675981 each, 40195327675982 case, Lot Numbers: 26CBI127; Medline SKU DYNJRA2390: UDI/DI 10195327675981 each, 40195327675982 case, Lot Numbers: 25JBD690; Medline SKU DYNJRA2390: UDI/DI 10195327675981 each, 40195327675982 case, Lot Numbers: 25HBD399; Medline SKU DYNJRA2390: UDI/DI 10195327675981 each, 40195327675982 case, Lot Numbers: 25GBL686; Medline SKU DYNJRA2390: UDI/DI 10195327675981 each, 40195327675982 case, Lot Numbers: 24FBT390; Medline SKU DYNJRA2402: UDI/DI 10198459003448 each, 40198459003449 case, Lot Numbers: 26BBP527; Medline SKU DYNJRA2402: UDI/DI 10198459003448 each, 40198459003449 case, Lot Numbers: 25HBS558; Medline SKU DYNJRA2402: UDI/DI 10198459003448 each, 40198459003449 case, Lot Numbers: 25HBJ268; Medline SKU DYNJRA2402: UDI/DI 10198459003448 each, 40198459003449 case, Lot Numbers: 24FBT392; Medline SKU DYNJRA2407: UDI/DI 10198459006401 each, 40198459006402 case, Lot Numbers: 24FBT391; Medline SKU DYNJRA2407A: UDI/DI 10198459342363 each, 40198459342364 case, Lot Numbers: 25LBL084; Medline SKU DYNJRA2407A: UDI/DI 10198459342363 each, 40198459342364 case, Lot Numbers: 25JBH939; Medline SKU DYNJRA2407B: UDI/DI 10198459660931 each, 40198459660932 case, Lot Numbers: 26CBF845; Medline SKU DYNJRA2447: UDI/DI 10198459048043 each, 40198459048044 case, Lot Numbers: 24GBJ538; Medline SKU DYNJRA2447A: UDI/DI 10198459340734 each, 40198459340735 case, Lot Numbers: 26CBD943; Medline SKU DYNJRA2447A: UDI/DI 10198459340734 each, 40198459340735 case, Lot Numbers: 25LBO163; Medline SKU DYNJRA2447A: UDI/DI 10198459340734 each, 40198459340735 case, Lot Numbers: 25JBE899; Medline SKU DYNJRA2447A: UDI/DI 10198459340734 each, 40198459340735 case, Lot Numbers: 25FBH740; Medline SKU DYNJRA2488A: UDI/DI 10198459221576 each, 40198459221577 case, Lot Numbers: 26BBG175; Medline SKU DYNJRA2488A: UDI/DI 10198459221576 each, 40198459221577 case, Lot Numbers: 25KBT792; Medline SKU DYNJRA2488A: UDI/DI 10198459221576 each, 40198459221577 case, Lot Numbers: 25HBN364; Medline SKU DYNJRA2488A: UDI/DI 10198459221576 each, 40198459221577 case, Lot Numbers: 25FBT533; Medline SKU DYNJRA2488A: UDI/DI 10198459221576 each, 40198459221577 case, Lot Numbers: 25EBS468; Medline SKU DYNJRA2488A: UDI/DI 10198459221576 each, 40198459221577 case, Lot Numbers: 25DBI026; Medline SKU DYNJRA2488A: UDI/DI 10198459221576 each, 40198459221577 case, Lot Numbers: 25ABV158; Medline SKU DYNJRA2545: UDI/DI 10198459218811 each, 40198459218812 case, Lot Numbers: 25IBS272; Medline SKU DYNJRA2545: UDI/DI 10198459218811 each, 40198459218812 case, Lot Numbers: 25GBQ078; Medline SKU DYNJRA2545: UDI/DI 10198459218811 each, 40198459218812 case, Lot Numbers: 25DBQ388; Medline SKU DYNJRA2549: UDI/DI 10198459223785 each, 40198459223786 case, Lot Numbers: 25HBJ272; Medline SKU DYNJRA2550: UDI/DI 10198459225192 each, 40198459225193 case, Lot Numbers: 26CBD941; Medline SKU DYNJRA2550: UDI/DI 10198459225192 each, 40198459225193 case, Lot Numbers: 26BBL404; Medline SKU DYNJRA2550: UDI/DI 10198459225192 each, 40198459225193 case, Lot Numbers: 26ABT283; Medline SKU DYNJRA2550: UDI/DI 10198459225192 each, 40198459225193 case, Lot Numbers: 25HBT630; Medline SKU DYNJRA2552: UDI/DI 10198459234972 each, 40198459234973 case, Lot Numbers: 26BBR448; Medline SKU DYNJRA2552: UDI/DI 10198459234972 each, 40198459234973 case, Lot Numbers: 26ABJ301; Medline SKU DYNJRA2552: UDI/DI 10198459234972 each, 40198459234973 case, Lot Numbers: 25KBN074; Medline SKU DYNJRA2552: UDI/DI 10198459234972 each, 40198459234973 case, Lot Numbers: 25IBQ405; Medline SKU DYNJRA2552: UDI/DI 10198459234972 each, 40198459234973 case, Lot Numbers: 25IBG233; Medline SKU DYNJRA2552: UDI/DI 10198459234972 each, 40198459234973 case, Lot Numbers: 25EBU153; Medline SKU DYNJRA2552: UDI/DI 10198459234972 each, 40198459234973 case, Lot Numbers: 25EBK087; Medline SKU DYNJRA2554: UDI/DI 10198459239243 each, 40198459239244 case, Lot Numbers: 25JBX901; Medline SKU DYNJRA2554: UDI/DI 10198459239243 each, 40198459239244 case, Lot Numbers: 25FBD587; Medline SKU DYNJRA2554A: UDI/DI 10198459694431 each, 40198459694432 case, Lot Numbers: 26BBM303; Medline SKU DYNJRA2578: UDI/DI 10198459275111 each, 40198459275112 case, Lot Numbers: 26BBO256; Medline SKU DYNJRA2578: UDI/DI 10198459275111 each, 40198459275112 case, Lot Numbers: 25LBJ013; Medline SKU DYNJRA2578: UDI/DI 10198459275111 each, 40198459275112 case, Lot Numbers: 25KBP759; Medline SKU DYNJRA2578: UDI/DI 10198459275111 each, 40198459275112 case, Lot Numbers: 25JBB370; Medline SKU DYNJRA2588: UDI/DI 10198459294624 each, 40198459294625 case, Lot Numbers: 26CBF842; Medline SKU DYNJRA2588: UDI/DI 10198459294624 each, 40198459294625 case, Lot Numbers: 26ABE836; Medline SKU DYNJRA2588: UDI/DI 10198459294624 each, 40198459294625 case, Lot Numbers: 25JBG955; Medline SKU DYNJRA2588: UDI/DI 10198459294624 each, 40198459294625 case, Lot Numbers: 25GBJ117; Medline SKU DYNJRA2588: UDI/DI 10198459294624 each, 40198459294625 case, Lot Numbers: 25DBQ696; Medline SKU DYNJRA2602: UDI/DI 10198459315855 each, 40198459315856 case, Lot Numbers: 26BBJ384; Medline SKU DYNJRA2602: UDI/DI 10198459315855 each, 40198459315856 case, Lot Numbers: 25JBH500; Medline SKU DYNJRA2602: UDI/DI 10198459315855 each, 40198459315856 case, Lot Numbers: 25IBE968; Medline SKU DYNJRA2602: UDI/DI 10198459315855 each, 40198459315856 case, Lot Numbers: 25DBQ059; Medline SKU DYNJRA2618: UDI/DI 10198459341731 each, 40198459341732 case, Lot Numbers: 25HBA436; Medline SKU DYNJRA2618: UDI/DI 10198459341731 each, 40198459341732 case, Lot Numbers: 25GBC673; Medline SKU DYNJRA2618: UDI/DI 10198459341731 each, 40198459341732 case, Lot Numbers: 25EBN435; Medline SKU DYNJRA2619: UDI/DI 10198459341793 each, 40198459341794 case, Lot Numbers: 25FBL039; Medline SKU DYNJRA2622: UDI/DI 10198459341885 each, 40198459341886 case, Lot Numbers: 26CBD468; Medline SKU DYNJRA2622: UDI/DI 10198459341885 each, 40198459341886 case, Lot Numbers: 26BBQ318; Medline SKU DYNJRA2622: UDI/DI 10198459341885 each, 40198459341886 case, Lot Numbers: 26BBF246; Medline SKU DYNJRA2622: UDI/DI 10198459341885 each, 40198459341886 case, Lot Numbers: 25FBD907; Medline SKU DYNJRA2624: UDI/DI 10198459341991 each, 40198459341992 case, Lot Numbers: 25FBG508; Medline SKU DYNJRA2631: UDI/DI 10198459347610 each, 40198459347611 case, Lot Numbers: 25FBF497; Medline SKU DYNJRA2632: UDI/DI 10198459347634 each, 40198459347635 case, Lot Numbers: 26BBJ396; Medline SKU DYNJRA2632: UDI/DI 10198459347634 each, 40198459347635 case, Lot Numbers: 26ABS300; Medline SKU DYNJRA2632: UDI/DI 10198459347634 each, 40198459347635 case, Lot Numbers: 25IBL870; Medline SKU DYNJRA2632: UDI/DI 10198459347634 each, 40198459347635 case, Lot Numbers: 25FBL040; Medline SKU DYNJRA2633: UDI/DI 10198459349461 each, 40198459349462 case, Lot Numbers: 26BBG178; Medline SKU DYNJRA2633: UDI/DI 10198459349461 each, 40198459349462 case, Lot Numbers: 26ABD972; Medline SKU DYNJRA2633: UDI/DI 10198459349461 each, 40198459349462 case, Lot Numbers: 25LBF464; Medline SKU DYNJRA2633: UDI/DI 10198459349461 each, 40198459349462 case, Lot Numbers: 25JBW886; Medline SKU DYNJRA2633: UDI/DI 10198459349461 each, 40198459349462 case, Lot Numbers: 25JBA813; Medline SKU DYNJRA2633: UDI/DI 10198459349461 each, 40198459349462 case, Lot Numbers: 25HBL703; Medline SKU DYNJRA2633: UDI/DI 10198459349461 each, 40198459349462 case, Lot Numbers: 25FBG791; Medline SKU DYNJRA2645: UDI/DI 10198459369629 each, 40198459369620 case, Lot Numbers: 26ABE851; Medline SKU DYNJRA2645: UDI/DI 10198459369629 each, 40198459369620 case, Lot Numbers: 26ABB344; Medline SKU DYNJRA2645: UDI/DI 10198459369629 each, 40198459369620 case, Lot Numbers: 26ABA200; Medline SKU DYNJRA2645: UDI/DI 10198459369629 each, 40198459369620 case, Lot Numbers: 25HBP475; Medline SKU DYNJRA2645: UDI/DI 10198459369629 each, 40198459369620 case, Lot Numbers: 25GBC666; Medline SKU DYNJRA2654: UDI/DI 10198459414114 each, 40198459414115 case, Lot Numbers: 25IBU953; Medline SKU DYNJRA2654: UDI/DI 10198459414114 each, 40198459414115 case, Lot Numbers: 25GBP675; Medline SKU DYNJRA2665: UDI/DI 10198459440618 each, 40198459440619 case, Lot Numbers: 25ILA934; Medline SKU DYNJRA2665: UDI/DI 10198459440618 each, 40198459440619 case, Lot Numbers: 25HLA408; Medline SKU DYNJRA2667: UDI/DI 10198459453656 each, 40198459453657 case, Lot Numbers: 25LBE224; Medline SKU DYNJRA2667: UDI/DI 10198459453656 each, 40198459453657 case, Lot Numbers: 25IBK727; Medline SKU DYNJRA2675: UDI/DI 10198459492600 each, 40198459492601 case, Lot Numbers: 25IBE846; Medline SKU DYNJRA2680: UDI/DI 10198459504365 each, 40198459504366 case, Lot Numbers: 25JBK134; Medline SKU DYNJRA2682: UDI/DI 10198459505317 each, 40198459505318 case, Lot Numbers: 25IBR245; Medline SKU DYNJRA2684: UDI/DI 10198459509148 each, 40198459509149 case, Lot Numbers: 26ABW308; Medline SKU DYNJRA2684: UDI/DI 10198459509148 each, 40198459509149 case, Lot Numbers: 25IBR247; Medline SKU DYNJRA2725: UDI/DI 10198459592386 each, 40198459592387 case, Lot Numbers: 25LBH997; Medline SKU DYNJRA2757: UDI/DI 10198459659676 each, 40198459659677 case, Lot Numbers: 26BBB965; Medline SKU DYNJRA9039: UDI/DI 10195327113834 each, 40195327113835 case, Lot Numbers: 25LBF214; Medline SKU DYNJRA9039: UDI/DI 10195327113834 each, 40195327113835 case, Lot Numbers: 25IBC977; Medline SKU DYNJRA9045: UDI/DI 10195327031251 each, 40195327031252 case, Lot Numbers: 25LBN162; Medline SKU DYNJRA9045: UDI/DI 10195327031251 each, 40195327031252 case, Lot Numbers: 25JBR086; Medline SKU DYNJRA9045: UDI/DI 10195327031251 each, 40195327031252 case, Lot Numbers: 25FBS501; Medline SKU DYNJRA9045: UDI/DI 10195327031251 each, 40195327031252 case, Lot Numbers: 25EBU898; Medline SKU PAIN2333: UDI/DI 10198459537981 each, 40198459537982 case, Lot Numbers: 26CLA730; Medline SKU PAIN2333: UDI/DI 10198459537981 each, 40198459537982 case, Lot Numbers: 25KLA519; Medline SKU SAMPA0135: UDI/DI 10198459018534 each, 40198459018535 case, Lot Numbers: 25DBQ390.
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
800-359-1704
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionMedline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 4/10/2026 via USPS first class mail and email. The notice explained the issue with the component and requested the following: - Identify and quarantine the affected item and lot numbers (kit). - Respond to notice via the portal: Website link: https://recalls.medline.com, Recall Reference #: R-26-065-FGX1, using the Recall Code provided. - Once the response is received, over-labels will be provided to be placed on the affected inventory with instructions to remove and discard the affected component. - Distributors or those who have further distributed the product are directed to notify those to whom the affected kits were distributed and include the customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce28106 kits
DistributionWorldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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