FDA-Device2026-10-22Class IIPROCESSING DEFECT

Medline sterile C-section surgical drape recalled for difficult removal and skin adhesive residue

OTHERNationwide distributionMedical devices

What this means

Medline Industries has recalled certain sterile surgical drapes used during cesarean sections because they can be difficult to remove from patients and may leave adhesive residue on the skin. The recall affects specific lot numbers distributed nationwide and internationally.

  • Check if your facility has affected lot numbers: 31124090032F, 31125080028F, 31126050023F, or 31126060021F
  • Stop using affected drapes and contact Medline Industries for replacement or instructions
  • Review patient records from procedures using these drapes and monitor for skin irritation or adhesive-related issues
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The agency's original wording
Hazard

Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
Affected count
4765 units
Manufactured in
3 Lakes Dr, Northfield, Illinois, United States
Products
MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0269-2027

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