There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots
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A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Recall Number
Z-1250-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-12-16
Reported
2026-02-11
Distribution
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.
Code Info
Pouch UDI 810123480456 Box UDI 810123480739 Lot 2410044
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.