RecallRadar

FDA Device recall Z-2268-2024

Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Len…

On 2024-07-10 the FDA classified a Class II recall of Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Len… by Stryker Sustainability Solutions, citing diagnostic electrophysiology (EP) catheters do not meet testing requirements.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2268-2024
ClassificationClass II
Statusongoing
Initiated2024-05-10
Published2024-07-10
Last updated2026-09-13 11:57 UTC
CompanyStryker Sustainability Solutions
Distributionn/a

Product

Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only

Reason

Diagnostic electrophysiology (EP) catheters do not meet testing requirements.

Identifiers

code_info(UDI):00885825011680/Serial #: 4175411, 4202651, 4116975, 4202652, 4175410, 4175402

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2268-2024%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.