Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH — Class I medical device recall Z-2365-2026
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-2365-2026 |
|---|---|
| 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 | 14,840 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10801902193275, 10801902203172, 10801902215014, 10801902216394, 10801902217261, 10801902221084 |
| Lot numbers | 10801902193275/33F24C0832, 10801902203172/33F24C0359, 10801902215014/33F25D0398, 10801902216394/33F24K0755, 10801902216394/33F24L0908, 33F24C1122, 33F24D0624, 33F24E0323, 33F24F0650, 33F24F0732, 33F24F0780, 33F24H0099, 33F24H0125, 33F24H0227, 33F24K0397, 33F24K0752, 33F24L0916, 33F25A0208, 33F25B0518, 33F25C0380, 33F25D0001, 33F25D0338, 33F25D0465, 33F25D0534, 33F25D0590, 33F25E0528, 33F25E0531, 33F25E0715, 33F25F0096, 33F25F0141, 33F25F0165, 33F25G0215, 33F25H0583, 33F25H0588, 33F25H0610, 33F25J0144, 33F25J0353, 33F25J0354, 33F25K0076, 33F25K0091 and 23 more |
| Model numbers | 10801902193275, 10801902193275/33F24C0832, 10801902203172/33F24C0359, 10801902215014/33F25D0398, 10801902216394/33F24K0755, 10801902216394/33F24L0908, 10801902217261, 10801902221084, 33F24C1122, 33F24D0624, 33F24E0323, 33F24F0650, 33F24F0732, 33F24F0780, 33F24H0099, 33F24H0125, 33F24H0227, 33F24K0397, 33F24K0752, 33F24L0916, 33F25A0208, 33F25B0518, 33F25C0380, 33F25D0001, 33F25D0338 and 41 more |
Product
Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU
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-2365-2026. 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.