Circuit, Breathing (w Connector, Adaptor, Y Piece)
Recall Summary Medline anesthesia trays (SKU DYNJRA1355A and DYNJRA2151) containing Huons Bupivacaine HCL in Dextrose Injection are being recalled due to quality concerns, including problems with microbiology testing data and reports that the medication may not work as intended. These kits were distributed nationwide across all U.S. states and territories, as well as to the Bahamas, Panama, and Barbados. This is a serious recall (Class I) affecting the injectable anesthetic included in these medical trays.
- 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.
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-10
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/5c38700d-3ef7-460f-b238-a9958e7e55b4