The Recall Desk

Manufacturer

Heidelberg Engineering GmbH

2 recalls in our database name Heidelberg Engineering GmbH as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2026-09-30

Of the 2 recalls from Heidelberg Engineering GmbH 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.

1–2 of 2

  • HighFDA (Devices)·Z-3215-2026·2026-09-30

    Heidelberg SPECTRALIS Flex Module Recall Due to Wheel Detachment Risk

    Heidelberg Engineering is recalling 87 SPECTRALIS units with Flex Modules because wheels may detach, causing the stand to tip over and injure nearby people.

    Product
    Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2437-2019·2019-09-11

    Heidelberg SPECTRALIS Ophthalmic Imaging Device Recalled for Data Display Error

    Heidelberg Engineering is recalling 29 SPECTRALIS ophthalmic imaging devices because a software configuration error may cause incorrect display of patient master data.

    Product
    SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
    Category
    Medical Device
    Distribution
    Distributed nationwide