Z-2268-2024Class II

Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301...

Name: Z-2268-2024 Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301...
Creator: Stryker Sustainability Solutions
Published: 2024-05-10
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2024-05-10 / Open, Classified / root cause: manufacturing process

FDA source

Stryker Sustainability Solutions began a recall of Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm... on 2024-05-10. FDA classified it as Class II and gives the reason as "Diagnostic electrophysiology (EP) catheters do not meet testing requirements". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2268-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-10
Posted: 2024-07-03
Recalling firm: Stryker Sustainability Solutions
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
Product code: NLH Catheter, Recording, Electrode, Reprocessed
Reason for recall: Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On June 11, 2024, Stryker Sustainability Solutions issued a Medical Device Recall notification to affected consignees. Stryker ask consignees to take the following action: 1. Please complete the Urgent Medical Device Recall Business Reply Form Attachment A (page 3) as an acknowledgement of this notification. Please return this completed form through one of the following methods: "Email: [email protected] or To your Stryker s Sustainability Solutions Sales Representative or via: Fax: 480-763-5345 5. 2.Maintain awareness of this communication internally. Response is required.
Quantity in commerce: 6 units
Distribution: International distribution to the country of Japan.
Product codes and lots: (UDI):00885825011680/Serial #: 4175411, 4202651, 4116975, 4202652, 4175410, 4175402

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2268-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2268-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03

Product code NLH

K112292Class IIReprocessed 2515 Nav Variable Electrophysiology CatheterStryker Sustainability Solutions / cleared 2011-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)