Heidelberg Engineering recalls

Heidelberg Engineering has 3 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 30 Sep 2026. 1 is still ongoing. 1 was reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls3since 2018

Last 12 months1reported

Class I00% of total

Ongoing1latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 1 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why heidelberg engineering is recalled

Product types

Imaging Equipment267%
Medical Software133%

By year

2026133%
2019133%
2018133%

Ongoing heidelberg engineering recalls

1 active

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	GmbH Spectralis with Flex Module recalled by Heidelberg Engineering	Heidelberg Engineering	Potency & Assay	Nationwide

All heidelberg engineering recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	GmbH Spectralis with Flex Module recalled by Heidelberg Engineering	Heidelberg Engineering	Potency & Assay	Nationwide
11 Sep 2019Device	CLASS II	Spectralis with HEYEX2 image management system recalled	Heidelberg Engineering	Other	Nationwide
2 May 2018Device	CLASS II	Widefield OCT recalled by Heidelberg Engineering	Heidelberg Engineering	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.