CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report
GmbH Spectralis with Flex Module recalled by Heidelberg Engineering
Heidelberg Engineering is recalling GmbH Spectralis with Flex Module, distributed nationwide in the US. The recall was initiated on 6 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3215-2026
- FDA event ID
- 99595
- Recalling firm
- Heidelberg Engineering, Heidelberg
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Aug 2026
- FDA classified
- 18 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Imaging Equipment
Timeline
| 6 Aug 2026 | Recall initiated by company | |
| 18 Sep 2026 | Classified by FDA | +43 days |
| 30 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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