Stryker Sustainability Solutions is recalling approximately 38,850 units of the Disposable 5 Lead Cable and Lead Wire System (50 inches). The packaging, which is supposed to contain specific approved lead systems and cables, may instead contain different ECG leads that are not approved for reprocessing but may have been reprocessed anyway. This error means the devices may not perform as intended during medical monitoring.
If an unapproved or incorrectly reprocessed lead wire is used, the device may fail to perform its monitoring functions correctly, which could lead to inaccurate medical data or device failure during patient care. While no specific injuries are mentioned in the data, the use of unapproved reprocessed components in a clinical setting poses a risk to patient safety.
Manufacturer initiated recall notification via letter
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.