Medline spinal anesthesia kits recalled for bupivacaine quality issues
Medline is recalling spinal anesthesia kits containing Huons bupivacaine hydrochloride due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. Affected kits were distributed worldwide.
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: FDA Class I classification applies, requiring a minimum severity score of 4 per the rubric. No reported deaths or serious injuries are documented in the source to elevate this to Critical. Quality and efficacy issues with an injectable anesthetic drug used in invasive procedures warrant a Severe classification.
Plain-English summary
Medline Industries is recalling 200,702 spinal anesthesia kits and related spinal trays that contain Huons Co. Bupivacaine Hydrochloride in Dextrose Injection, USP. The recalled products are identified by various Medline SKUs (DYNJRA series) and were distributed worldwide, including in the U.S., Virgin Islands, Bahamas, Panama, and Barbados.
The kits were recalled due to quality issues affecting the bupivacaine product, specifically microbiology testing data integrity concerns and reported complaints regarding the drug's efficacy. These issues raise questions about whether the anesthetic in the kits will perform as intended when administered to patients.
Healthcare providers and facilities using these kits should discontinue use and contact Medline or consult the FDA for guidance on product replacement or proper disposal. Patients who received spinal anesthesia from these kits and experienced unexpected anesthetic failure should contact their healthcare provider.
The recalled product
- Product
- 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 Ki
- Manufacturer
- Medline Industries, LP
- Hazard
- efficacy-failure
- data-integrity
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 Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each
- 40884389459004 case
- Lot Number 26ABG838
- Lot Number 25JBR222
- Lot Number 25IBJ307
- Lot Number 25EBR346
- Lot Number 24LDB145
- 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
- Lot Number 26BMK211
- Lot Number 25JMC385
- Lot Number 25IMB105
Distribution
Distributed nationwide across the United States.
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