Stryker Sustainability Solutions, BW Lasso 2515 NAV eco… recallZ-2268-2024 · Stryker Sustainability Solutions · initiated May 10, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Sustainability Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2268-2024
- Status
- Open, Classified
- Initiated by the company
- May 10, 2024
- Posted by the FDA
- Jul 3, 2024
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 6 units
- Product code
- NLH
- FDA submissions
- K112292
- Distribution
- International distribution to the country of Japan.
Product description
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
Code information (models, lots, serial numbers)
(UDI):00885825011680/Serial #: 4175411, 4202651, 4116975, 4202652, 4175410, 4175402
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- N/AStryker Sustainability Solutions, Inc. · CATHETER, RECORDING, ELECTRODE, REPROCESSED1 recall2 reports
Other devices under the same FDA submission
1 device cleared under K112292 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- N/AStryker Sustainability Solutions, Inc. · CATHETER, RECORDING, ELECTRODE, REPROCESSED1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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