The Recall Desk

Manufacturer

Haag-Streit USA Inc

9 recalls in our database name Haag-Streit USA Inc as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
0
Most recent
2022-01-19

Of the 9 recalls from Haag-Streit USA Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

  • HighFDA (Devices)·Z-0478-2022·2022-01-19

    OCT Camera Laser Safety Shut-Off Malfunction Affects Three Units

    Haag-Streit USA is recalling OCT-Camera 211 01 A3 units due to malfunction of the automatic laser beam shut-off. The device may not correctly recognize when the laser beam is safely switched off.

    Product
    OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2022·2022-01-19

    OCT-Camera Laser Shut-Off Malfunction Poses Patient Safety Risk

    Haag-Streit OCT-Camera devices with automatic laser shut-off malfunction may fail to recognize when the laser is safely switched off, posing a potential safety risk.

    Product
    OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1560-2021·2021-05-19

    Haag-Streit LENSTAR LS900 Software Recall for Data Mixing Errors

    Haag-Streit USA Inc is recalling Eyesuite 9.3.1 software for LENSTAR LS900 devices due to potential mixing of patient names and examination data.

    Product
    Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2021·2020-12-30

    Haag-Streit Surgical Floor Stands Recalled for Software Error

    Haag-Streit USA Inc. is recalling surgical floor stands and operating microscopes due to a software error that may cause focusing movement to continue after the footswitch is released.

    Product
    Haag 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2483-2019·2019-09-11

    Haag-Streit Operating Microscope Floor Stand Software Error Recall

    Haag-Streit USA Inc is recalling specific operating microscope floor stands due to a software error in the central control unit.

    Product
    HS Hi-R NEO 900A Reference # 657 821 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 H
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2484-2019·2019-09-11

    Haag-Streit Recalls HS Hi-R NEO 900A Operating Microscopes Due to Software Error

    Haag-Streit USA Inc is recalling HS Hi-R NEO 900A operating microscopes and specific floor stands due to a software error in the central control unit.

    Product
    HS Hi-R NEO 900A NIR Reference # 657 822 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/
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2482-2019·2019-09-11

    Haag-Streit Recalls HS Hi-R NEO 900 Operating Microscopes Due to Software Error

    Haag-Streit USA Inc is recalling HS Hi-R NEO 900 operating microscopes because a software error in the floor stand's central control unit may affect device function.

    Product
    HS 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 H
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1500-2017·2017-03-29

    Haag-Streit EyeSuite Software Recalled for Potential Patient Data Misattribution

    Haag-Streit USA Inc is recalling EyeSuite i.8.2.1.0 software due to a risk that patient data may be stored under the wrong patient on the DICOM Server.

    Product
    EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2411-2012·2012-09-26

    Haag-Streit Recalls Octopus 101 Perimeters Due to Luminance Deviation

    Haag-Streit USA Inc recalled 64 Octopus 101 Perimeters because of a possible deviation in stimulus luminance. The devices are used to determine the extent of a patient's peripheral visual field.

    Product
    Octopus 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Haag-Streit Holding

Founded
1858

Official website

Source: Wikidata (Q1566264), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.