Revanesse Versa — Class II medical device recall Z-1146-2020
Terminated recall by Prollenium Medical Technologies Inc., reported 2020-02-19, distributed nationwide. Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 1
| Recall number | Z-1146-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Prollenium Medical Technologies Inc., Aurora, Canada |
| Recall initiated | 2018-11-15 |
| Classified | 2020-02-10 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2024-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 48,457 kits |
| Reason classes | labeling |
| Lot numbers | 17K004, 17K005, 17K007, 17K090, 17K091, 17L026, 17L028, 17L0S1, 181022, 181029, 18A023, 18A024, 18E029, 18F032, 18F033, 18G065, 18G074, 18G075, 18G076, I7K006, I7L050, I8E028 |
Product
Revanesse Versa, PN40081
Reason for recall
Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
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-1146-2020. 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.