Medline Anesthesia Kits Recalled for Quality and Efficacy Concerns
Medline is recalling 1100 anesthesia trays containing Bupivacaine due to quality issues, microbiology testing data integrity concerns, and reported efficacy complaints. The kits were distributed worldwide to healthcare facilities.
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 of medical device kits, which establishes a minimum severity score of 4 under regulatory classification. The recall involves microbiology testing data integrity concerns and reported efficacy failures, but no deaths or serious injuries are reported.
Plain-English summary
Medline Industries is recalling 1100 anesthesia kits distributed under two product lines: ANESTHESIA TRAY (SKU DYNJRA1355A) and SPINAL ANESTHESIA TRAY (SKU DYNJRA2151). These kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP manufactured by Huons Co.
The recall was initiated due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints regarding the injectable anesthetic component.
The affected kits were distributed worldwide, with specific distribution documented to the United States, U.S. Virgin Islands, Bahamas, Panama, and Barbados. Healthcare facilities and providers using these kits should verify their inventory against the product lot numbers and discontinue use of affected products immediately.
The recalled product
- Product
- Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.
- Manufacturer
- Medline Industries, LP
- Hazard
- testing-integrity
- reduced-efficacy
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 (10)
- Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each
- FI case
- Lot Numbers: 26CBA272
- Lot Numbers: 26ABS307
- Lot Numbers: 25HBE663
- Lot Numbers: 25FBA408
- Lot Numbers: 25CBG043
- Lot Numbers: 24FBT395
- Medline SKU DYNJRA2151: UDI/DI 10195327365400 each
- Lot Numbers: 24FBT396.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03