Z-1691-2025Class II

Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual...

Name: Z-1691-2025 Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual...
Creator: Defibtech, LLC
Published: 2025-03-18
License: https://open.fda.gov/license/

Defibtech LLC / initiated 2025-03-18 / Open, Classified / root cause: manufacturing process

FDA source

Defibtech, LLC began a recall of Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language) on 2025-03-18. FDA classified it as Class II and gives the reason as "It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1691-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-18
Posted: 2025-04-29
Recalling firm: Defibtech LLC
Product: Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language)
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On March 18, 2025 URGENT FIELD SAFETY NOTICE letters were emailed to customers. Actions to be taken by the Customer/User: 1. Confirm receipt of this notice by replying to this email with RECEIVED 2. Please complete the attached Customer Reply Form and email the form to FA2025- [email protected]. 3. Attached to this Field Safety Notice, you will find the 3 Instructions For Use (Operator Guide) in the required languages. Please take the attached 3 Instructions For Use (Operator Guide) and keep with the affected AED(s). If you have questions now, please feel free to contact us using the email address: [email protected]. Defibtech is committed to ensuring our products meet the highest quality standards and that our customers are fully supported. I sincerely apologize for any inconvenience this may cause you. As always, Defibtech Customer Support is available by calling 1-877-453-4507, 7:30 A.M. to 6:00 P.M. (Eastern), Monday - Friday. Thank you for your attention and cooperation.
Quantity in commerce: 13 units (OUS only)
Distribution: International Only: Switzerland.
Product codes and lots: UDI-DIs; 00815098020195 (DDU-2200, export version), 10815098020192 (DDU-2200, export version (configuration level)); Lot numbers: 400184748, 400170814, 400180780, 400142381, 400142390, 400142995, 400145936, 400145955, 400149039, 400149042, 400149094, 400145977, 400149090.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1691-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1690-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-29
Z-1691-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-29
Z-1692-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-29
Z-1693-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-29

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)