Z-2950-2026 Class II Ongoing
FDA device recall Z-2950-2026 was initiated by Covidien, LLC on May 13, 2026 and is designated Class II. Reason for recall: The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures. The recall status is ongoing. Affected quantity: 327.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2026
- Initiation Date
- May 13, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 327
Product Description
Reason for Recall
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Costa Rica, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Netherlands, New Zealand, Northern Ireland, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom.