Class I U.S. Food and Drug Administration

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose recall: Medline kits were distributed containing Huons Bupivacaine Hydrochloride

Recall published 5 months ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2237-2026
Published
June 3, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
200702 kits
Distribution
Nationwide
Made in
United States
Lot / code info
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, 40193489432016 case, Lot Number 25GMB242; Medline Kit SKU DYNJRA1140B: UDI/DI 10193489432…
UPC codes
10884389459003, 40884389459004, 10195327125820, 40195327125821, 10195327472344, 40195327472345, 10195327282042, 40195327282043, 10884389656778, 40884389656779, 10198459027796, 40198459027797, 10195327253363, 40195327253364, 10195327120689, 40195327120680, 10889942598267, 40889942598268, 10193489432015, 40193489432016

Products covered by this recall

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

Check your product

The notice names 61 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10884389459003
  • 40884389459004
  • 10195327125820
  • 40195327125821
  • 10195327472344
  • 40195327472345
  • 10195327282042
  • 40195327282043
  • 10884389656778
  • 40884389656779
  • 10198459027796
  • 40198459027797
  • 10195327253363
  • 40195327253364
  • 10195327120689
  • 40195327120680
  • 10889942598267
  • 40889942598268
  • 10193489432015
  • 40193489432016

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 26ABG838
  • 25JBR222
  • 25IBJ307
  • 25EBR346
  • 24LDB145
  • 24FDB896
  • 24ABQ670
  • 24KMD212
  • 26CMG585
  • 26BMK211
  • 25JMC385
  • 25IMB105
  • 25EMC687
  • 24HMD675
  • 24HMB249
  • 24GMH436
  • 24EDB314
  • 24BDA550
  • 26ABJ309
  • 25HBT750

Model or item number

On the rating label, the box or the instruction sheet.

  • DYNJRA0102A
  • DYNJRA0143B
  • DYNJRA0205B
  • DYNJRA0255B
  • DYNJRA0320
  • DYNJRA0320A
  • DYNJRA0413C
  • DYNJRA0461D
  • DYNJRA0945
  • DYNJRA1140B
  • DYNJRA1192
  • DYNJRA1240
  • DYNJRA1288
  • DYNJRA1301
  • DYNJRA1304
  • DYNJRA1376
  • DYNJRA1477A
  • DYNJRA1538
  • DYNJRA1558A
  • DYNJRA1560A

Package size

Match the net weight or the piece count on the front of the pack.

  • 3 ML

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10884389459003, 40884389459004, 10195327125820; lot code 26ABG838, 25JBR222, 25IBJ307; model number DYNJRA0102A, DYNJRA0143B, DYNJRA0205B. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls