FDA-Device2026-10-22Class IIPROCESSING DEFECT

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

OTHERNationwide distributionMedical devices

What this means

Medline's fenestrated C-section drape (product number DYNJP6108) is difficult to remove from patients and can leave adhesive residue on skin. The issue affects specific lot numbers distributed worldwide.

  • Check if your facility received this product (lot numbers 45025120094 or 45025120253).
  • Review Medline's guidance on safe removal techniques for affected drapes.
  • Contact Medline for instructions on returning or disposing of affected units.
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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
2569 units
Manufactured in
3 Lakes Dr, Northfield, Illinois, United States
Products
MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0271-2027

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