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Open, Classified

Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT/XALT

FDA Recall Z-1564-2026 · Posted 2026-03-12

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodePUI
Date Initiated2026-01-28
Product Quantity23,568

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.

Firm Action

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

Distribution Pattern

Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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