FDA-Device2026-03-18Class IIPROCESSING DEFECT
Medline surgical drapes recalled for premature fabric delamination
What this means
Medline surgical drapes and gowns may fall apart (delaminate) when washed using the included instructions. If a delaminated drape is used during surgery, it could tear and allow bacteria through, increasing infection risk.
- Stop using affected Medline surgical drapes immediately
- Check product model numbers: MDTBTCS6070GN, MDTBTCS6090GN, MDTDXUNDBGN, MDTMAYOXGN, MDTZ1003656GN
- Contact Medline or your hospital supply department for a replacement or refund
- Review surgical inventory for affected lots before next use
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.
Affected count
23,568
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1564-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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