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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Surgical Drapes

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 Class 2 Device Recall Medline Surgical Drapessee related information
Date Initiated by FirmJanuary 28, 2026
Date PostedMarch 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1564-2026
Recall Event ID 98430
Product Classification Drape, surgical, exempt - Product Code PUI
ProductMedline 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
Code Information UDI-DI (each/case) 10193489036961 20193489036968 10193489036978 20193489036975 10193489040098 20193489040095 10193489036954 20193489036951 10193489036985 20193489036982 All lots affected
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
800-633-5463
Manufacturer 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.
FDA Determined
Cause 2		Labeling Change Control
ActionOn 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.
Quantity in Commerce23,568
DistributionDomestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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