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SPECTRALIS with Flex Module

Official notice

30 Sept 2026

Last checked

6 Oct 2026

MediumFDA

An official FDA notice concerns Heidelberg Engineering. The notice reports an injury risk. Stop using the product and follow the official notice. Published 2026-09-30. Recall numbers: Z-3215-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

87

Recall number

Z-3215-2026

Official notice

2026-09-30

The hazard

Injury risk

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Other

UDI-DI 04059237000235

Event Ids

99595

Recall Numbers

Z-3215-2026

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Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

AT · Austria

Affected area 3

AU · Australia

Affected area 4

CA · Canada

Affected area 5

CH · Switzerland

Affected area 6

CR · Costa Rica

Affected area 7

CZ · Czech Republic

Affected area 8

DE · Germany

Affected area 9

ES · Spain

Affected area 10

FR · France

Affected area 11

GB · United Kingdom

Affected area 12

IL · Israel

Affected area 13

IN · India

Affected area 14

IT · Italy

Affected area 15

MX · Mexico

Affected area 16

NL · Netherlands

Affected area 17

PL · Poland

Affected area 18

SA · Saudi Arabia

Affected area 19

TH · Thailand

Affected area 20

VN · Vietnam

Affected area 21

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Heidelberg Engineering. Contact: Heidelberg Engineering GmbH.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-3215-2026

Event id

99595

Units affected

87

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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