Orapharma — Class II medical device recall Z-1699-2016
Terminated recall by Valeant Pharmacueticals International, reported 2016-05-25, distributed nationwide. It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. How
| Recall number | Z-1699-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmacueticals International, Bridgewater, NJ, United States |
| Recall initiated | 2016-01-29 |
| Classified | 2016-05-19 |
| Reported by FDA | 2016-05-25 |
| Terminated | 2017-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 7,716 |
| Reason classes | labeling |
| Model numbers | 1054-02 |
Product
Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.
Reason for recall
It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. However, the current labeling and IFU does not stipulate this time period.
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-1699-2016. 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.