Class II — Prollenium Medical Technologies Inc.
| Recalling firm | Prollenium Medical Technologies Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months. |
| Product | Revanesse Versa, PN40081 |
| Quantity | 48,457 kits |
| Distribution | US Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA |
| Initiated | 2018-11-15 |
| Classified | 2020-02-10 |
| Terminated | 2024-03-22 |
| Recall number | Z-1146-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Prollenium Medical Technologies Inc. (Z-1146-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83834/
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