FDA Medical Device Recalls (openFDA)
Stryker Sustainability Solutions: 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
- Recall number
- Z-2268-2024
- 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
- Status
- Open, Classified
- Initiated
- 2024-05-10
- Posted
- 2024-07-03
- Terminated
- not on file
- Reason
- Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
- 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: SSSPFA@stryker.com 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
- 6 units
- Distribution
- International distribution to the country of Japan.
- Lot, serial or model codes
- (UDI):00885825011680/Serial #: 4175411, 4202651, 4116975, 4202652, 4175410, 4175402
- 510(k) numbers
- ["K112292"]
- PMA numbers
- not on file
- Product code
- NLH
- Firm FEI
- 3002615969
- Firm city
- Phoenix
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28