Description/REF: ACCESS TRAY/ASK-04001-SUH-S — Class I medical device recall Z-2364-2026
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-2364-2026 |
|---|---|
| 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 | 205,685 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10801902119916, 10801902193275, 10801902202076, 10801902202106, 10801902202236, 10801902202243, 10801902202496, 10801902206876, 10801902209433, 10801902209471, 10801902209617, 10801902209853, 10801902210057, 10801902210064, 10801902210125, 10801902210132, 10801902210149, 10801902210156, 10801902210217, 10801902210354, 10801902210385, 10801902214291, 10801902214857, 40801902202220 |
| Lot numbers | 10801902119916/33F24E0586, 10801902193275/33F24C0260, 10801902193275/33F24L0599, 10801902193275/33F25C0766, 10801902202236/33F24G0309, 10801902202243/33F24G0496, 10801902209471/33F24E0312, 10801902209471/33F24L0608, 10801902209617/33F24J0596, 10801902209853/33F24E0506, 10801902210064/33F24D0393, 10801902210125/33F24G0533, 10801902210132/33F24E0026, 10801902210149/33F24C0259, 10801902210217/33F24D0002, 10801902210354/33F24E0779, 10801902210385/33F24B0166, 10801902214291/33F24E0536, 33F23G0580, 33F24A1057, 33F24B0386, 33F24C0054, 33F24C0194, 33F24C0211, 33F24C0230, 33F24C0231, 33F24C0258, 33F24C0276, 33F24D0064, 33F24D0394, 33F24D0407, 33F24D0437, 33F24D0628, 33F24E0014, 33F24E0028, 33F24E0029, 33F24E0314, 33F24E0507, 33F24E0533, 33F24E0574 and 195 more |
| Model numbers | 10801902119916/33F24E0586, 10801902193275/33F24C0260, 10801902193275/33F24L0599, 10801902193275/33F25C0766, 10801902202076, 10801902202106, 10801902202236/33F24G0309, 10801902202243/33F24G0496, 10801902202496, 10801902206876, 10801902209471/33F24E0312, 10801902209471/33F24L0608, 10801902209617/33F24J0596, 10801902209853/33F24E0506, 10801902210064, 10801902210064/33F24D0393, 10801902210125/33F24G0533, 10801902210132, 10801902210132/33F24E0026, 10801902210149, 10801902210149/33F24C0259, 10801902210217, 10801902210217/33F24D0002, 10801902210354/33F24E0779, 10801902210385/33F24B0166 and 228 more |
Product
Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM NDL/AB-05060-PK; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/ASK-19609-VCU; CONTINUOUS NERVE BLOCK KIT/ASK-19600-CC2; CONTINUOUS NERVE BLOCK KIT 19 GA X 60/ASK-19608-CC; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-KP; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-SHC; FLEXBLOCK KIT:ECHO CATH, 17Gx8CM STM NDL/FB-19608-K; FLEXBLOCK ULTRASOUND KIT: 17Gx8CM STM ND/FB-19608-KU; FLEXBLOCK KIT:ECHO CATH, 17Gx9CM NS NDL/FB-19609-K; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/FB-19609-KU; CONTINUOUS PERIPHERAL NERVE BLOCK KIT/ASK-19608-US1; EPIDURAL CATHETERIZATION KIT/ASK-05001-SLR1; EPIDURAL CATHETERIZATION KIT/MH-05001; EPIDURAL CATHETERIZATION KIT/WJ-05401; SPINAL ANES/EPIDURAL CATH 19GA X 90CM/ASK-05501-USC1; EPIDURAL NEEDLE KIT/LG-03000; EPIDURAL ANESTHESIA KIT/MTO-03000-VM; EPIDURAL ANESTHESIA KIT/SM-03001; Anesthesia conduction kit/FB-19611-K
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-2364-2026. 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.