RecallRadar

FDA Device recall Z-0955-2023

COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

On 2023-01-18 the FDA classified a Class II recall of COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1 by Covidien, citing the product is labeled with the incorrect expiration date.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0955-2023
ClassificationClass II
Statusongoing
Initiated2022-11-23
Published2023-01-18
Last updated2026-09-13 11:56 UTC
CompanyCovidien
Distributionn/a

Product

COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

Reason

The product is labeled with the incorrect expiration date.

Identifiers

code_infoUDI/DI (GTIN): 10884521825765, Lot Number: 520200

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0955-2023%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.