RecallRadar

FDA Device recall Z-0420-2021

Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monit…

On 2020-11-11 the FDA classified a Class II recall of Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monit… by 3m Health Care Business, citing corrosion could cause performance failures in the product.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0420-2021
ClassificationClass II
Statusterminated
Initiated2020-09-15
Published2020-11-11
Last updated2026-09-13 11:55 UTC
Company3m Health Care Business
DistributionUS

Product

Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total).

Reason

Corrosion could cause performance failures in the product.

Identifiers

code_infoCat. No. V2560-3 (SKU: 70-2011-8380-6, SAP #: 7100205820). GTIN: 10707387788169 (pouch); 50707387788167 (shipper) Lots: 202201EB (Expiration 2022-01-01)

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0420-2021%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.