Heidelberg Engineering recall: SPECTRALIS with Flex Module
Heidelberg Engineering GmbH is recalling SPECTRALIS with Flex Module because of a tip-over hazard – 87. The U.S. Food and Drug Administration published the recall on September 30, 2026; it began on August 6, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | SPECTRALIS with Flex Module |
| Brand | Heidelberg Engineering |
| Company | Heidelberg Engineering GmbH |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 6, 2026 |
| Published by FDA | September 30, 2026 |
| Quantity | 87 |
| Recall ID | 99595 |
Recalled products
- 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
- FDA recall number
- Z-3215-2026
- Codes, lots and dates
- 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
- Quantity
- 87
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99595
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Heidelberg, Germany
Why it was recalled
The problem: a tip-over hazard.
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “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 to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99595, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Heidelberg Engineering SPECTRALIS with Flex Module recalled?
Yes. Heidelberg Engineering GmbH recalled it on August 6, 2026; FDA published it September 30, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Because of a tip-over hazard. The reason given: 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.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.