AERO IOL Injection System containing 10 Z28 Cartridges per box — Class II medical device recall Z-0071-2018
Terminated recall by Aaren Scientific Inc., reported 2017-11-15, distributed nationwide. The recommended storage temperature on the label is incorrect.
| Recall number | Z-0071-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aaren Scientific Inc., Ontario, CA, United States |
| Recall initiated | 2017-09-01 |
| Classified | 2017-11-08 |
| Reported by FDA | 2017-11-15 |
| Terminated | 2018-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 786 boxes |
| Reason classes | labeling |
| Lot numbers | 160204, 160505, 161006, 161018, 161028, 161219, 170120 |
| Model numbers | 003500-0025-282 |
Product
AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's.
Reason for recall
The recommended storage temperature on the label is incorrect.
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-0071-2018. 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.