Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic… — Class II medical device recall Z-0380-2017

Terminated recall by Stryker Sustainability Solutions, reported 2016-11-16, distributed in AZ, MN, MO. The EP Catheters may be mislabeled for French size during reprocessing.

Recall number	`Z-0380-2017`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Stryker Sustainability Solutions, Tempe, AZ, United States
Recall initiated	2016-10-06
Classified	2016-11-09
Reported by FDA	2016-11-16
Terminated	2016-12-16
Distributed	AZ, MN, MO
Quantity	4 devices
Reason classes	labeling
UPC / GTIN / UDI-DI	`00885825007409`, `00885825007744`
Model numbers	`401940`, `402004`

Product

Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. Reprocessed Diagnostic EP Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

Reason for recall

The EP Catheters may be mislabeled for French size during reprocessing.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0380-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.