INJECTOR FORCEMAX UP 2 — Class II medical device recall Z-1010-2021
Terminated recall by Aomori Olympus Co., Ltd., reported 2021-02-17, distributed nationwide. Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal).
| Recall number | Z-1010-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aomori Olympus Co., Ltd., Kuroishi, N/A, Japan |
| Recall initiated | 2021-01-04 |
| Classified | 2021-02-05 |
| Reported by FDA | 2021-02-17 |
| Terminated | 2024-03-11 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| Model numbers | NM-400L-0621 |
Product
INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Reason for recall
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
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-1010-2021. 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.