Class IOngoingZ-2237-2026

Medline Industries, LP recalls Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection

Medline Industries, LPNorthfield, IL, United StatesReported Jun 3, 2026 · 1 month ago

Legal News Analyst · Jun 3, 2026

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 product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL ANESTHESIA TRAY-LF, Medline Kit SKU DYNJRA0102A; 2) SPINAL TRAY-LF, Medline Kit SKU DYNJRA0143B; 3) SPINAL PREP TRAY-LF, Medline Kit SKU DYNJRA0205B; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0255B; 5) SPINAL TRAY, Medline Kit SKU DYNJRA0320; 6) SPINAL TRAY, Medline Kit SKU DYNJRA0320A; 7) SPINAL BLOCK TRAY- LF, Medline Kit SKU DYNJRA0413C; 8) SPINAL TRAY, Medline Kit SKU DYNJRA0461D; 9) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA0945; 10) SPINAL TRAY, Medline Kit SKU DYNJRA1140B; 11) SPINAL TRAY, Medline Kit SKU DYNJRA1192; 12) SPINAL TRAY 25G, Medline Kit SKU DYNJRA1240; 13) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1288; 14) SPINAL 25G WHITACRE, Medline Kit SKU DYNJRA1301; 15) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1304; 16) AHN SPINAL TRAY, Medline Kit SKU DYNJRA1376; 17) SPINAL TRAY, Medline Kit SKU DYNJRA1477A; 18) ADULT SPINAL KIT, Medline Kit SKU DYNJRA1538; 19) SPINAL TRAY, Medline Kit SKU DYNJRA1558A; 20) SPINAL TRAY, Medline Kit SKU DYNJRA1560A; 21) SPINAL TRAY, Medline Kit SKU DYNJRA1565; 22) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA1577C; 23) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1584; 24) 25G WHITACRE SPINAL TRAY, Medline Kit SKU DYNJRA1740A; 25) SPINAL TRAY, Medline Kit SKU DYNJRA1744A; 26) SPINAL TRAY, Medline Kit SKU DYNJRA1750A; 27) SPINAL TRAY, Medline Kit SKU DYNJRA1784; 28) SPINAL TRAY, Medline Kit SKU DYNJRA1790; 29) SPINAL TRAY, Medline Kit SKU DYNJRA1796; 30) MSSC SPINAL TRAY, Medline Kit SKU DYNJRA1802B; 31) SPINAL TRAY, Medline Kit SKU DYNJRA1818; 32) SPINAL TRAY, Medline Kit SKU DYNJRA1839; 33) SPINAL TRAY, Medline Kit SKU DYNJRA1884; 34) SPINAL TRAY, Medline Kit SKU DYNJRA1884A; 35) 24G SPINAL KIT, Medline Kit SKU DYNJRA1889; 36) SPINAL TRAY, Medline Kit SKU DYNJRA1929; 37) SPINAL TRAY, Medline Kit SKU DYNJRA1969; 38) SPINAL TRAY, Medline Kit SKU DYNJRA1982; 39) SPINAL TRAY/PENCAN, Medline Kit SKU DYNJRA1983A; 40) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1987; 41) SPINAL TRAY - 3 ML CHLORAPREP, Medline Kit SKU DYNJRA2005; 42) SPINAL TRAY, Medline Kit SKU DYNJRA2023; 43) SPINAL TRAY, Medline Kit SKU DYNJRA2068A; 44) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2088; 45) 25G WHITACRE SPINAL TRAY, Medline Kit SKU DYNJRA2115; 46) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2117; 47) SPINAL TRAY, Medline Kit SKU DYNJRA2140; 48) SPINAL TRAY, Medline Kit SKU DYNJRA2153; 49) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA2213; 50) SPINAL TRAY, Medline Kit SKU DYNJRA2225; 51) OR SPINAL BLOCK KIT, Medline Kit SKU DYNJRA2349; 52) SPINAL TRAY, Medline Kit SKU DYNJRA2360; 53) L&D SPINAL TRAY, Medline Kit SKU DYNJRA2371; 54) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2381; 55) SPINAL TRAY, Medline Kit SKU DYNJRA2432A; 56) OB SPINAL TRAY, Medline Kit SKU DYNJRA2532; 57) SPINAL TRAY, Medline Kit SKU DYNJRA2534; 58) SPINAL TRAY, Medline Kit SKU DYNJRA2556; 59) SPINAL TRAY, Medline Kit SKU DYNJRA2566A; 60) SPINAL TRAY BRAUN, Medline Kit SKU DYNJRA2575; 61) SPINAL TRAY, Medline Kit SKU DYNJRA2592; 62) SPINAL TRAY, Medline Kit SKU DYNJRA2597; 63) SPINAL BLOCK, Medline Kit SKU DYNJRA2605; 64) SPINAL TRAY, Medline Kit SKU DYNJRA2606; 65) SPINAL TRAY, Medline Kit SKU DYNJRA2607; 66) SPINAL TRAY, Medline Kit SKU DYNJRA2607A; 67) SPINAL TRAY, Medline Kit SKU DYNJRA2611; 68) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2613; 69) SPINAL TRAY, Medline Kit SKU DYNJRA2618A; 70) SPINAL TRAY, Medline Kit SKU DYNJRA2634; 71) SPINAL TRAY, Medline Kit SKU DYNJRA2638; 72) SPINAL TRAY, Medline Kit SKU DYNJRA2639; 73) JOI SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2641; 74) SPINAL TRAY, Medline Kit SKU DYNJRA2653; 75) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2669; 76) SPINAL TRAY, Medline Kit SKU DYNJRA2670; 77) SPINAL BLOCK TRAY 18G INTRO, Medline Kit SKU DYNJRA2672; 78) SPINAL TRAY 24G, Medline Kit

Lot / code information

Lot #: 26ABG838; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case
Lot #: 25JBR222; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case
Lot #: 25IBJ307; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case
Lot #: 25EBR346; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case
Lot #: 24LDB145; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case
Lot #: 24FDB896; Medline Kit SKU DYNJRA0143B: UDI/DI 10195327125820 each, 40195327125821 case
Lot #: 24ABQ670; Medline Kit SKU DYNJRA0205B: UDI/DI 10195327472344 each, 40195327472345 case
Lot #: 24KMD212; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case
Lot #: 26CMG585; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case
Lot #: 26BMK211; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case

Additional code information

Medline Kit SKU DYNJRA2556: UDI/DI 10198459247514 each, 40198459247515 case, Lot Number 26BBE200; Medline Kit SKU DYNJRA2556: UDI/DI 10198459247514 each, 40198459247515 case, Lot Number 25LBN290; Medline Kit SKU DYNJRA2556: UDI/DI 10198459247514 each, 40198459247515 case, Lot Number 25KBQ920; Medline Kit SKU DYNJRA2556: UDI/DI 10198459247514 each, 40198459247515 case, Lot Number 25JBU726; Medline Kit SKU DYNJRA2556: UDI/DI 10198459247514 each, 40198459247515 case, Lot Number 25JBC448; Medline Kit SKU DYNJRA2556: UDI/DI 10198459247514 each, 40198459247515 case, Lot Number 25HBS669; Medline Kit SKU DYNJRA2556: UDI/DI 10198459247514 each, 40198459247515 case, Lot Number 25FBR642; Medline Kit SKU DYNJRA2556: UDI/DI 10198459247514 each, 40198459247515 case, Lot Number 25DBI029; Medline Kit SKU DYNJRA2566A: UDI/DI 10198459421822 each, 40198459421823 case, Lot Number 26CBD938; Medline Kit SKU DYNJRA2566A: UDI/DI 10198459421822 each, 40198459421823 case, Lot Number 25HBP480; Medline Kit SKU DYNJRA2566A: UDI/DI 10198459421822 each, 40198459421823 case, Lot Number 25HBK616; Medline Kit SKU DYNJRA2575: UDI/DI 10198459271830 each, 40198459271831 case, Lot Number 25LBC427; Medline Kit SKU DYNJRA2575: UDI/DI 10198459271830 each, 40198459271831 case, Lot Number 25JBX992; Medline Kit SKU DYNJRA2575: UDI/DI 10198459271830 each, 40198459271831 case, Lot Number 25JBC445; Medline Kit SKU DYNJRA2575: UDI/DI 10198459271830 each, 40198459271831 case, Lot Number 25GBO568; Medline Kit SKU DYNJRA2575: UDI/DI 10198459271830 each, 40198459271831 case, Lot Number 25GBB711; Medline Kit SKU DYNJRA2575: UDI/DI 10198459271830 each, 40198459271831 case, Lot Number 25GBG218; Medline Kit SKU DYNJRA2575: UDI/DI 10198459271830 each, 40198459271831 case, Lot Number 25BBH733; Medline Kit SKU DYNJRA2592: UDI/DI 10198459300417 each, 40198459300418 case, Lot Number 26ABL364; Medline Kit SKU DYNJRA2592: UDI/DI 10198459300417 each, 40198459300418 case, Lot Number 25KBT846; Medline Kit SKU DYNJRA2592: UDI/DI 10198459300417 each, 40198459300418 case, Lot Number 25FBC729; Medline Kit SKU DYNJRA2597: UDI/DI 10198459304835 each, 40198459304836 case, Lot Number 25GBN789; Medline Kit SKU DYNJRA2597: UDI/DI 10198459304835 each, 40198459304836 case, Lot Number 25EBA564; Medline Kit SKU DYNJRA2605: UDI/DI 10198459326370 each, 40198459326371 case, Lot Number 26ABQ772; Medline Kit SKU DYNJRA2605: UDI/DI 10198459326370 each, 40198459326371 case, Lot Number 26ABK647; Medline Kit SKU DYNJRA2605: UDI/DI 10198459326370 each, 40198459326371 case, Lot Number 25KBT820; Medline Kit SKU DYNJRA2605: UDI/DI 10198459326370 each, 40198459326371 case, Lot Number 25FBG507; Medline Kit SKU DYNJRA2606: UDI/DI 10198459328657 each, 40198459328658 case, Lot Number 25LBF412; Medline Kit SKU DYNJRA2606: UDI/DI 10198459328657 each, 40198459328658 case, Lot Number 25JBM797; Medline Kit SKU DYNJRA2606: UDI/DI 10198459328657 each, 40198459328658 case, Lot Number 25FBT691; Medline Kit SKU DYNJRA2606: UDI/DI 10198459328657 each, 40198459328658 case, Lot Number 25EBC231; Medline Kit SKU DYNJRA2607: UDI/DI 10198459331657 each, 40198459331658 case, Lot Number 25EBK954; Medline Kit SKU DYNJRA2607A: UDI/DI 10198459421839 each, 40198459421830 case, Lot Number 26CBI128; Medline Kit SKU DYNJRA2607A: UDI/DI 10198459421839 each, 40198459421830 case, Lot Number 26ABV387; Medline Kit SKU DYNJRA2611: UDI/DI 10198459336256 each, 40198459336257 case, Lot Number 26BBB084; Medline Kit SKU DYNJRA2611: UDI/DI 10198459336256 each, 40198459336257 case, Lot Number 25LBN247; Medline Kit SKU DYNJRA2611: UDI/DI 10198459336256 each, 40198459336257 case, Lot Number 25IBB903; Medline Kit SKU DYNJRA2611: UDI/DI 10198459336256 each, 40198459336257 case, Lot Number 25EBF537; Medline Kit SKU DYNJRA2613: UDI/DI 10198459339356 each, 40198459339357 case, Lot Number 25EBR108; Medline Kit SKU DYNJRA2618A: UDI/DI 10198459537998 each, 40198459537999 case, Lot Number 26CBE369; Medline Kit SKU DYNJRA2618A: UDI/DI 10198459537998 each, 40198459537999 case, Lot Number 26ABJ331; Medline Kit SKU DYNJRA2634: UDI/DI 10198459349355 each, 40198459349356 case, Lot Number 26BBL356; Medline Kit SKU DYNJRA2634: UDI/DI 10198459349355 each, 40198459349356 case, Lot Number 25JBA669; Medline Kit SKU DYNJRA2634: UDI/DI 10198459349355 each, 40198459349356 case, Lot Number 25FBP070; Medline Kit SKU DYNJRA2638: UDI/DI 10198459349591 each, 40198459349592 case, Lot Number 25FBG845; Medline Kit SKU DYNJRA2639: UDI/DI 10198459352218 each, 40198459352219 case, Lot Number 25FBU637; Medline Kit SKU DYNJRA2641: UDI/DI 10198459352546 each, 40198459352547 case, Lot Number 26BBE022; Medline Kit SKU DYNJRA2641: UDI/DI 10198459352546 each, 40198459352547 case, Lot Number 25EBO148; Medline Kit SKU DYNJRA2653: UDI/DI 10198459411021 each, 40198459411022 case, Lot Number 25IBL292; Medline Kit SKU DYNJRA2669: UDI/DI 10198459466489 each, 40198459466480 case, Lot Number 26CBI134; Medline Kit SKU DYNJRA2669: UDI/DI 10198459466489 each, 40198459466480 case, Lot Number 26BBJ402; Medline Kit SKU DYNJRA2669: UDI/DI 10198459466489 each, 40198459466480 case, Lot Number 25LBF213; Medline Kit SKU DYNJRA2669: UDI/DI 10198459466489 each, 40198459466480 case, Lot Number 25IBL293; Medline Kit SKU DYNJRA2670: UDI/DI 10198459467974 each, 40198459467975 case, Lot Number 25HBQ154; Medline Kit SKU DYNJRA2672: UDI/DI 10198459475382 each, 40198459475383 case, Lot Number 26CBD940; Medline Kit SKU DYNJRA2672: UDI/DI 10198459475382 each, 40198459475383 case, Lot Number 25KBT183; Medline Kit SKU DYNJRA2672: UDI/DI 10198459475382 each, 40198459475383 case, Lot Number 25HBT583; Medline Kit SKU DYNJRA2675A: UDI/DI 10198459616471 each, 40198459616472 case, Lot Number 26ABV388; Medline Kit SKU DYNJRA2700: UDI/DI 10198459540615 each, 40198459540616 case, Lot Number 26BBC162; Medline Kit SKU DYNJRA2700: UDI/DI 10198459540615 each, 40198459540616 case, Lot Number 25LBA445; Medline Kit SKU DYNJRA2700: UDI/DI 10198459540615 each, 40198459540616 case, Lot Number 25JBO627; Medline Kit SKU DYNJRA2708: UDI/DI 10198459555756 each, 40198459555757 case, Lot Number 26BBN582; Medline Kit SKU DYNJRA2708: UDI/DI 10198459555756 each, 40198459555757 case, Lot Number 26BBL108; Medline Kit SKU DYNJRA2708: UDI/DI 10198459555756 each, 40198459555757 case, Lot Number 25KBT823; Medline Kit SKU DYNJRA2710: UDI/DI 10198459559075 each, 40198459559076 case, Lot Number 25LBL119; Medline Kit SKU DYNJRA2710: UDI/DI 10198459559075 each, 40198459559076 case, Lot Number 25KBM981; Medline Kit SKU DYNJRA2710: UDI/DI 10198459559075 each, 40198459559076 case, Lot Number 25JBD673; Medline Kit SKU DYNJRA9029: UDI/DI 10889942466436 each, 40889942466437 case, Lot Number 25KBD330; Medline Kit SKU DYNJRA9029: UDI/DI 10889942466436 each, 40889942466437 case, Lot Number 25KBB936; Medline Kit SKU DYNJRA9029: UDI/DI 10889942466436 each, 40889942466437 case, Lot Number 25JBB447; Medline Kit SKU DYNJRA9029: UDI/DI 10889942466436 each, 40889942466437 case, Lot Number 24FBJ029; Medline Kit SKU DYNJRA9029: UDI/DI 10889942466436 each, 40889942466437 case, Lot Number 24BBR611; Medline Kit SKU DYNJRA9029: UDI/DI 10889942466436 each, 40889942466437 case, Lot Number 23JBM198; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 26ABR020; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 26ABG927; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 25LBH190; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 25KBR348; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 25JBV917; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 25JBL130; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 25JBH184; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 25IBW244; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 25DBE496; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 25DBE497; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 25DBD657; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 25DBE019; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 25CBK276; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 25CBH117; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 25CBE763; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 25CBD665; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 24GBD232; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 24FBJ504; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 24FBJ509; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 24BBR622; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 24BBR604; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 23JBH420; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 23JBH419; Medline Kit SKU DYNJRA9034: UDI/DI 10193489467574 each, 40193489467575 case, Lot Number 23FBR086; Medline Kit SKU DYNJRA9038: UDI/DI 10193489830477 each, 40193489830478 case, Lot Number 26BBQ555; Medline Kit SKU DYNJRA9038: UDI/DI 10193489830477 each, 40193489830478 case, Lot Number 26BBM438; Medline Kit SKU DYNJRA9038: UDI/DI 10193489830477 each, 40193489830478 case, Lot Number 26ABM602; Medline Kit SKU DYNJRA9038: UDI/DI 10193489830477 each, 40193489830478 case, Lot Number 25KBS235; Medline Kit SKU DYNJRA9038: UDI/DI 10193489830477 each, 40193489830478 case, Lot Number 25GBO785; Medline Kit SKU DYNJRA9038: UDI/DI 10193489830477 each, 40193489830478 case, Lot Number 25FBM871; Medline Kit SKU DYNJRA9038: UDI/DI 10193489830477 each, 40193489830478 case, Lot Number 25ABC406; Medline Kit SKU DYNJRA9038: UDI/DI 10193489830477 each, 40193489830478 case, Lot Number 24FBJ512; Medline Kit SKU DYNJRA9038: UDI/DI 10193489830477 each, 40193489830478 case, Lot Number 24FBJ126; Medline Kit SKU DYNJRA9038: UDI/DI 10193489830477 each, 40193489830478 case, Lot Number 24BBR602; Medline Kit SKU PAIN1279A: UDI/DI 10193489302509 each, 40193489302500 case, Lot Number 26BBC168; Medline Kit SKU PAIN1279A: UDI/DI 10193489302509 each, 40193489302500 case, Lot Number 25LBF437; Medline Kit SKU PAIN1279A: UDI/DI 10193489302509 each, 40193489302500 case, Lot Number 25JBC449; Medline Kit SKU PAIN1279A: UDI/DI 10193489302509 each, 40193489302500 case, Lot Number 25HBU729; Medline Kit SKU PAIN1279A: UDI/DI 10193489302509 each, 40193489302500 case, Lot Number 25HBM736; Medline Kit SKU PAIN1279A: UDI/DI 10193489302509 each, 40193489302500 case, Lot Number 25GBW272; Medline Kit SKU PAIN1279A: UDI/DI 10193489302509 each, 40193489302500 case, Lot Number 25BBM498; Medline Kit SKU PAIN1279A: UDI/DI 10193489302509 each, 40193489302500 case, Lot Number 25ALA737; Medline Kit SKU PAIN1279A: UDI/DI 10193489302509 each, 40193489302500 case, Lot Number 25ALA309; Medline Kit SKU PAIN1279A: UDI/DI 10193489302509 each, 40193489302500 case, Lot Number 24KLA204; Medline Kit SKU PAIN1279A: UDI/DI 10193489302509 each, 40193489302500 case, Lot Number 24FLA466; Medline Kit SKU PAIN1279A: UDI/DI 10193489302509 each, 40193489302500 case, Lot Number 24ALB132; Medline Kit SKU PAIN1279A: UDI/DI 10193489302509 each, 40193489302500 case, Lot Number 23ILA681; Medli …

What the firm is doing

Medline 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.

DistributionShow details

Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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