Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB — Class I medical device recall Z-2389-2026
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-2389-2026 |
|---|---|
| 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 | 79,614 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10801902193275, 10801902201994, 10801902202007, 10801902202014, 10801902202274, 10801902202281, 10801902206692, 10801902210217 |
| Lot numbers | 10801902193275/33F24D0396, 10801902193275/33F24D0397, 10801902193275/33F24E0089, 10801902193275/33F24E0380, 10801902193275/33F24E0548, 10801902201994/33F24G0383, 33F24E0090, 33F24E0381, 33F24E0544, 33F24E0547, 33F24G0274, 33F24G0384, 33F24G0505, 33F24K0145, 33F24K0146, 33F24K0147, 33F24K0260, 33F24L0545, 33F24L0550, 33F24L0589, 33F24L0602, 33F24L0636, 33F24L0654, 33F24L0696, 33F24L0755, 33F25A0491, 33F25A0492, 33F25A0493, 33F25A0575, 33F25A0621, 33F25B0374, 33F25C0123, 33F25C0182, 33F25C0183, 33F25C0774, 33F25C0806, 33F25C0831, 33F25C0838, 33F25C0844, 33F25C0943 and 38 more |
| Model numbers | 10801902193275/33F24D0396, 10801902193275/33F24D0397, 10801902193275/33F24E0089, 10801902193275/33F24E0380, 10801902193275/33F24E0548, 10801902201994/33F24G0383, 33F24E0090, 33F24E0381, 33F24E0544, 33F24E0547, 33F24G0274, 33F24G0384, 33F24G0505, 33F24K0145, 33F24K0146, 33F24K0147, 33F24K0260, 33F24L0545, 33F24L0550, 33F24L0589, 33F24L0602, 33F24L0636, 33F24L0654, 33F24L0696, 33F24L0755 and 53 more |
Product
Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090-SB; SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA; SPINAL ANESTHESIA KIT: 25 GA X 9 CM/ASK-24090-SPH; SPINAL ANESTHESIA KIT/ASK-25090-BIDMC; SPINAL ANESTHESIA KIT/ASK-25090-UF
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-2389-2026. 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.