Medline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
Medline Industries recalled approximately 28,106 anesthesia kits containing Huons bupivacaine due to microbiology testing data integrity concerns and reported efficacy complaints.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which per the rubric requires a minimum severity score of 4. The recall involves quality issues in a sterile injectable anesthetic product, with documented microbiology testing data integrity concerns and reported efficacy complaints indicating real-world product failures.
Plain-English summary
Medline Industries, LP has recalled approximately 28,106 anesthesia and pain management kits containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP. The affected kits are distributed under 52 different Medline SKU numbers and are used for spinal anesthesia, pain management, and nerve block procedures.
The recall was issued due to quality issues, specifically microbiology testing data integrity concerns and reported efficacy complaints. These problems raise concerns about the quality and effectiveness of the injectable medication contained in the kits.
The recalled kits were distributed nationwide throughout the United States and internationally to the US Territory of Virgin Islands and the countries of Bahamas, Panama, and Barbados. Healthcare facilities and surgical centers are potentially affected.
Information about affected lot numbers and SKU numbers for this recall is available from Medline Industries.
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 — Anesthetic Kit
- Hazard
- data-integrity
- efficacy-failure
- contamination
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.
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