Class II — Clarus Medical, Llc
| Recalling firm | CLARUS MEDICAL, LLC. |
|---|---|
| Registered facility | CLARUS MEDICAL, LLC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The sterile barrier seal may be compromised. |
| Product | Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002 |
| Quantity | 858 units |
| Distribution | Distribution in US - 18 accounts 1 foreign account |
| Initiated | 2021-07-27 |
| Classified | 2021-09-02 |
| Terminated | 2022-09-15 |
| Recall number | Z-2405-2021 |
| 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 — Clarus Medical, Llc (Z-2405-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88399/
Alerts for CLARUS MEDICAL, LLC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.