Recall Register

Haag-Streit USA Inc: FDA recalls

FDA enforcement reports name Haag-Streit USA Inc as the recalling firm in 6 events. The events have 9 product records. The recalls started from 2012 to 2021. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

6 events, newest first.

FDA enforcement events of Haag-Streit USA Inc
InitiatedProduct (first record)TypeClassRecordsStatus
3 Nov 2021OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4DeviceClass II2Ongoing
15 Apr 2021Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.DeviceClass II1Ongoing
20 Nov 2020Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines…DeviceClass II1Ongoing
31 Jul 2019HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90…DeviceClass II3Terminated
5 Jan 2017EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).DeviceClass II1Terminated
17 Aug 2012Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Haag-Streit USA Inc: events for each product type
TypeEvents
Device6
Haag-Streit USA Inc: events in each class
ClassEvents
Class II6
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
3

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Haag-Streit USA Inc, by the year that the recall started. The largest year is 2021, with 2 events.

Official channels

Cite this page

Recall Register. Haag-Streit USA Inc: FDA recalls. https://recallregister.com/firm/haag-streit-usa-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
OH

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Haag-Streit USA Inc have?
Class II: 6 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Haag-Streit USA Inc?
FDA event 89176, which the firm started on 3 Nov 2021. The first product in the record is: OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
How many FDA recalls of Haag-Streit USA Inc have the status Ongoing?
3 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.