Facility

Haag-Streit Deutschland GmbH

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011022890
Establishment type	Export Device to the United States But Perform No Other Operation on Device
Location	ROSENGARTEN 10, WEDEL Schleswig-Holstein, DE 22880
Registration status	Active · expires 2026
Parent company	HAAG-STREIT HOLDING (owner-operator 8031066)
Brand names	HS Surgical Microscopes, Carrier and Accessories: Hi-R NEO 900(;900A) / FS 2-25 / Accessories; Metis 3D Digital Heads-Up Module; Metis 900

Activity by year

Recalls (6)

Devices registered here (1)

Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Product code HRM (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4700

Recalls & enforcement

Class IIOngoing2021-11-03
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Class IIOngoing2021-04-15
Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).
Class IIOngoing2020-11-20
Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye
Class IITerminated2019-07-31
software error in the central control unit of the floor stand.
Class IITerminated2017-01-05
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
Class IITerminated2012-08-17
The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Haag-Streit Deutschland GmbH (FEI 3011022890) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011022890-haag-streit-deutschland-gmbh/

Not open yet

Alerts for Haag-Streit Deutschland GmbH

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.

Planned

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.