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Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESI

FDA device recall Z-1564-2026 · posted 2026-03-12 · Open, Classified

Recall details

Recalling firm
Medline Industries, LP
Reason for recall
Fabric may experience premature delamination when using included laundering instructions. 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.
Action taken
On January 28, 2026, the firm notified customers of the issue through Urgent Medical Device Recall letters. Users were provided with updated laundering instructions and general inspection guidelines.
Root cause
Labeling Change Control
Status
Open, Classified
Product code
PUI
Quantity affected
23,568
Distribution
Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.
Date initiated
2026-01-28
Date posted
2026-03-12
Location
Northfield, IL

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