Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8 — Class II medical device recall Z-2423-2021
Terminated recall by Olympus Corporation of the Americas, reported 2021-09-15, distributed nationwide. Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
| Recall number | Z-2423-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2021-08-03 |
| Classified | 2021-09-03 |
| Reported by FDA | 2021-09-15 |
| Terminated | 2023-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 711,157 units |
| Reason classes | sterility, packaging |
| Lot numbers | 60780, 60862, 60865, 60867, 60869, 61168, 61171, 61176, 61285, 61578, 61580, 61582, 61662, 61664, 62007, 62009, 62011, 62013, 62146, 62149, 62151, 62405, 62407, 62469, 62471, 62473, 62781, 62783, 62787, 63035, 63037, 63039, 63310, 63314, 63316, 63582, 63584, 63586, 64132, 64134 and 59 more |
| Model numbers | E0420500, E0420501, E0420502, E0420503 |
Product
Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy
Reason for recall
Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
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-2423-2021. 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.