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

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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-2236-2026
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
30120 kits
Distribution
Nationwide
Made in
United States
Lot / code info
Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26BBJ392; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26ABS354; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25LBC413; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25IBK142; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25FBD584; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25BBK828; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 24FBT398; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 24BBR608; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23JBB581; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23IBQ010; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23HBM569; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 26AMK346; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25KMG102; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25JMA641; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25GMC349; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25DMG474; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25DMC357; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25ADB659; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 24LDB606; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 24KDB682; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 24JDC049; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 24FDA638; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 23JDC468; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 26BBJ394; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25LBR313; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25KBP760; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25JBV827; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25JBG134; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25HBK390; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25DBF619; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 26BBT340; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 26ABU446; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25JBE914; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25GBT022; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25EBS286; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25DBJ529; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25ADA237; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24JDB280; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24FDA639; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24EDB329; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 c…
UPC codes
10889942879236, 40889942879237, 10889942935864, 40889942935865, 10198459155666, 40198459155667, 10888277789838, 40888277789839

Products covered by this recall

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097; 2) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1154; 3) SPINAL TRAY, Medline Kit SKU DYNJRA1192A; 4) BLOCK TRAY, Medline Kit SKU DYNJRA1212; 5) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1285; 6) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA9031; 7) SPINAL BLOCK TRAY 25G WHITACRE, Medline Kit SKU DYNJRA9032; 8) 25G SPINAL TRAY, Medline Kit SKU PAIN1239.

Check your product

The notice names 35 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.

  • 10889942879236
  • 40889942879237
  • 10889942935864
  • 40889942935865
  • 10198459155666
  • 40198459155667
  • 10888277789838
  • 40888277789839

Lot or batch code

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

  • 26BBJ392
  • 26ABS354
  • 25LBC413
  • 25IBK142
  • 25FBD584
  • 25BBK828
  • 24FBT398
  • 24BBR608
  • 23JBB581
  • 23IBQ010
  • 23HBM569
  • 26AMK346
  • 25KMG102
  • 25JMA641
  • 25GMC349
  • 25DMG474
  • 25DMC357
  • 25ADB659
  • 24LDB606
  • 24KDB682

Model or item number

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

  • DYNJRA1097
  • DYNJRA1154
  • DYNJRA1192A
  • DYNJRA1212
  • DYNJRA1285
  • DYNJRA9031
  • DYNJRA9032

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  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.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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 10889942879236, 40889942879237, 10889942935864; lot code 26BBJ392, 26ABS354, 25LBC413; model number DYNJRA1097, DYNJRA1154, DYNJRA1192A. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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