Fabric may experience premature delamination when using included laundering instructions
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Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.
Recall Number
Z-1564-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-01-28
Reported
2026-03-18
Distribution
Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.