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
Published September 30, 2026 · Recall initiated: August 6, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Heidelberg Engineering GmbH
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
Related recalls
- FDAImager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/…September 30, 2026
- FDAOlympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.September 30, 2026
- FDAHalyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Mo…September 30, 2026
- FDAMidmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse …September 30, 2026
- FDAINCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units p…September 30, 2026
- FDAMidmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse …September 30, 2026
- FDAINCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per bo…September 30, 2026
- FDAMidmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse …September 30, 2026
Questions about this recall
Was 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 recalled?
Yes. FDA published recall Z-3215-2026 on September 30, 2026. Reported hazard: 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 this product?
Voluntary: Firm initiated · Letter
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.
Recalert also tracks expiration dates so you can sell stock before it becomes a loss.