Home/Recalls/FDA-Z-1564-2026
FDA DevicesClass II

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

Published: March 18, 2026Recall ID: Z-1564-2026Category: devicesCountry: US

Reason for Recall / 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.

Product Description & Identification

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

Affected 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

Additional Source Details

FieldValue
CityNorthfield
StateIL
Event id98430
Address 13 Lakes Dr
Address 2N/A
Code infoUDI-DI (each/case) 10193489036961 20193489036968 10193489036978 20193489036975 10193489040098 20193489040095 10193489036954 20193489036951 10193489036985 20193489036982 All lots affected
Postal code60093-2753
Report date20260318
Product typeDevices
Product quantity23,568
Reason for recallFabric 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260128
Initial firm notificationLetter
Center classification date20260312

Overview

  • Recalling FirmMedline Industries, LP
  • StatusOngoing
  • Risk LevelClass II
  • DistributionDomestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.
Official Agency Alert