Heidelberg Engineering GmbH recalls Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module

Recalling company

Heidelberg Engineering GmbH

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

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Aug 6, 2026

Reported

Sep 30, 2026

Distribution

Worldwide - US Nationwide distribution in the state of Massachusetts and the countries of Australia, Costa Rica, Germany, France, India, Israel, Italy, Canada, Mexico, Netherlands, Austria, Philippines, Poland, Saudi Arabia, Switzerland, Spain. South Africa. Thailand, Czech Republic, United Kingdom, Vietnam.

Status

Ongoing

Quantity

87

Lot / codes

UDI-DI 04059237000235 Lot Code: Spec-07265, Spec-11121, Spec-11281, Spec-12096, Spec-13305, Spec-14403, Spec-15282, Spec-15587, Spec-20071, Spec-20348, Spec-20351, Spec-20591, Spec-20605, Spec-23473, Spec-23941, Spec-23950, Spec-23975, Spec-24507, Spec-24558, Spec-24582, Spec-24611

Company location

Heidelberg

Recall type

Voluntary: Firm initiated

Recall number

Z-3215-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3215-2026 in the FDA Enforcement Report. Also see FDA recall press releases.