Class II — Haag-Streit USA Inc
| Recalling firm | HAAG-STREIT HOLDING |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off |
| Product | OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 |
| Quantity | 2 devices quarantined in US |
| Distribution | US Nationwide distribution in the states of OH, IN. |
| Initiated | 2021-11-03 |
| Classified | 2022-01-10 |
| Recall number | Z-0477-2022 |
| 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 — Haag-Streit USA Inc (Z-0477-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89176/
Alerts for HAAG-STREIT HOLDING
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.