The Recall Desk
HighFDA (Devices)·Z-2232-2026·Announced 2026-06-03

[pending] Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN

Pending LLM rewrite. Source: FDA_DEVICE Z-2232-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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 recalled product

Product
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
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Medline SKU DYNJRA1555: UDI/DI 10193489238723 each
  • 40193489238724 case
  • Lot Numbers: 25CLA724
  • Lot Numbers: 25CLA306
  • Medline SKU DYNJRA1817: UDI/DI 10193489942354 each
  • 40193489942355 case
  • Lot Numbers: 25JMH667
  • Lot Numbers: 25JMC856
  • Lot Numbers: 25JMA370
  • Lot Numbers: 25IMI402
  • Lot Numbers: 25HME985
  • Lot Numbers: 25AMI063
  • Lot Numbers: 24JMI488
  • Lot Numbers: 24JMA113
  • Lot Numbers: 23KMD776
  • Medline SKU DYNJRA1920: UDI/DI 10195327111168 each
  • 40195327111169 case
  • Lot Numbers: 25FBQ144
  • Medline SKU DYNJRA2013: UDI/DI 10195327212049 each
  • 40195327212040 case

Distribution

Distributed nationwide across the United States.

Related recalls

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