Z-1250-2026 Class II Ongoing
FDA device recall Z-1250-2026 was initiated by Vortex Surgical Inc. on December 16, 2025 and is designated Class II. Reason for recall: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to … The recall status is ongoing. Affected quantity: 14,789 (8651 US; 6138 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- February 11, 2026
- Initiation Date
- December 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,789 (8651 US; 6138 OUS)
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.