Reported Sep 30, 2026 · Ongoing · Updated Oct 6, 2026
Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610,…
Heidelberg Engineering GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heidelberg Engineering GmbH · Max-Jarecki-Str. 8 · Heidelberg · N/A
Is this the product you have?
- Brand NameHeidelberg
- Engineering GmbH Product NameSPECTRALIS
- with Flex Module Model/Catalog NumberS3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye
- Lot codes and dates
- UDI-DI 04059237000235 Lot Code
Spec-07265Spec-11121Spec-11281Spec-12096Spec-13305Spec-14403Spec-15282Spec-15587Spec-20071Spec-20348Spec-20351Spec-20591Spec-20605Spec-23473Spec-23941Spec-23950Spec-23975Spec-24507Spec-24558Spec-24582Spec-24611
- UDI-DI 04059237000235 Lot Code
- Amount recalled
- 87
Where it was sold
- Nationwide
- MA
Why it was recalled
Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons.
This product could cause temporary or reversible health problems — stop using it.
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