RecallRadar

FDA Device recall Z-1708-2016

Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters

On 2016-06-01 the FDA classified a Class II recall of Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters by Stryker Sustainability Solutions, citing mislabeled for size.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1708-2016
ClassificationClass II
Statusterminated
Initiated2016-04-28
Published2016-06-01
Last updated2026-09-13 11:54 UTC
CompanyStryker Sustainability Solutions
DistributionNY

Product

Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

Reason

Mislabeled for size

Identifiers

code_infoCatalog Number: 401450 Lot Number: 2561683E Expiration Date: 5/13/2017 Catalog Number: 401877 Lot Number: 2555866E Expiration Date: 5/6/2017

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1708-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.