Description/REF: ACCESS TRAY/ASK-04001-MC3 — Class I medical device recall Z-2392-2026
Ongoing recall by ARROW INTERNATIONAL, LLC, reported 2026-06-24, distributed nationwide. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits an
| Recall number | Z-2392-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARROW INTERNATIONAL, LLC, Morrisville, NC, United States |
| Recall initiated | 2026-04-21 |
| Classified | 2026-06-12 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 8,265 |
| Reason classes | sterility |
| Lot numbers | ASK-04001-MC3 |
| Model numbers | ASK-04001-MC3 |
Product
Description/REF: ACCESS TRAY/ASK-04001-MC3
Reason for recall
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2392-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.