FDA-Device2026-10-22Class IIPACKAGING DEFECT

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

OTHERNationwide distributionMedical devices

What this means

Medline Industries' C-section fenestrated clear surgical drape (model DYNJP6106) is difficult to remove from patients and can leave adhesive residue on skin. The issue affects 161 units distributed worldwide, including the US, Canada, Australia, and the UAE.

  • If you have this product in stock, quarantine and do not use it
  • Contact Medline Industries for return or replacement instructions
  • If already used on a patient, monitor the affected area for skin irritation
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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
All ages
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
Affected count
161 units
Manufactured in
3 Lakes Dr, Northfield, Illinois, United States
Products
MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0270-2027

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