FDA Device recall Z-2389-2026
Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB
- FDA Device
- Class I
- ongoing
- Published 2026-06-24
On 2026-06-24 the FDA classified a Class I recall of Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB by Arrow International, citing 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 rep….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2389-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-04-21 |
| Published | 2026-06-24 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Arrow International |
| Distribution | US |
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
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.
Identifiers
| code_info | REF(Material)/UDI-DI/Lot(Batch): ASA-24090-SB/10801902193275, 10801902201994/33F24G0383, 33F24K0145, 33F24L0550, 33F25A…REF(Material)/UDI-DI/Lot(Batch): ASA-24090-SB/10801902193275, 10801902201994/33F24G0383, 33F24K0145, 33F24L0550, 33F25A0491, 33F25C0838, 33F25E0094, 33F25H0044, 33F25J0490, 33F25L0444, 33S25E0094; ASA-24103-SB/10801902202007, 10801902193275/33F24E0380, 33F24E0381, 33F24G0274, 33F24K0146, 33F24L0696, 33F25A0492, 33F25C0123, 33F25C0774, 33F25E0095, 33F25G0097, 33F25H0045, 33F25J0491, 33F25L0329, 33F26B0494; ASA-25090-SB/10801902202014, 10801902193275/33F24E0089, 33F24E0090, 33F24G0384, 33F24K0147, 33F24L0545, 33F24L0755, 33F25A0493, 33F25A0621, 33F25B0374, 33F25C0844, 33F25E0097, 33F25G0098, 33F25H0046, 33F25J0850, 33F25K0257; ASK-24090-SA/10801902202281, 10801902193275/33F24D0396, 33F24E0544, 33F24L0589, 33F25C0182, 33F25C0965, 33F25E0228, 33F25H0146, 33F25J0922, 33F26B0573; ASK-24090-SPH/10801902202274, 10801902193275/33F24D0397, 33F24G0505, 33F24K0260, 33F24L0654, 33F25A0575, 33F25C0943, 33F25E1026, 33F25H0753, 33F25K0410, 33F26B0501; ASK-25090-BIDMC/10801902210217/33F24E0546, 33 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2389-2026%22
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