FDA-Device2026-03-18Class IIPROCESSING DEFECT

Medline Medcrest Surgical Gowns recalled for fabric delamination risk

OTHERNationwide distributionMedical devices

What this means

Medline surgical gowns may develop fabric separation (delamination) when laundered using the included instructions. If a separated gown is used during surgery, fluid or bacteria could pass through the compromised fabric, potentially increasing infection risk.

  • Stop using affected Medline Medcrest Surgical Gowns immediately
  • Check your inventory for the model numbers listed in the recall (MDTGXC4J, MDTGXP4J, MDTL1002862EF, MDTZ1000893AJ, and related variants)
  • Contact Medline Industries for instructions on returning or replacing affected gowns
  • Do not launder or reuse any identified affected gowns
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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
104,004
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L MDTGXP4JXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTGXP4JXXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XX MDTL1002862EF DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTZ1000893AJ DBD-GOWN,SRG,PNL CVR, GREEN,SNPS,XL

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1563-2026

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