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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medline Surgical Gowns and Drapes Recalled for Infection Risk

Agency Publication Date: March 12, 2026
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Summary

Medline Industries, LP has recalled 127,572 surgical gowns and drapes because the fabric may peel or separate (delaminate) if the provided laundering instructions are followed. If a delaminated gown or drape is used during surgery, fluids may pass through the material, which could lead to a risk of infection for both patients and healthcare workers. Identifying these defective products in a surgical environment may also cause delays in patient care.

Risk

The delamination of the fabric compromises the protective barrier of the surgical gown or drape, allowing for 'surgical strikethrough' where fluids can penetrate the material and potentially cause infections.

What You Should Do

  1. Check your inventory for Medcrest Surgical Gowns or Medline Surgical Drapes. See the Affected Products section below for the full list of affected codes.
  2. Identify affected products by checking the catalog number and UDI-DI on the packaging labels.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline Medcrest Surgical Gowns
Variants: Green, Large, XL, XXL, 5XL
Model / REF:
MDTGXC4J5XL
MDTGXC4JL
MDTGXC4JXL
MDTGXC4JXXL
MDTGXP4JL
MDTGXP4JXL
MDTGXP4JXXL
MDTL1002862EF
MDTZ1000893AJ
Lot Numbers:
All lots affected
UDI:
10197344014002
20197344014009
10888277189188
40888277189189
10884389189191
40884389189192
10884389193297
40884389193298
10888277189218
40888277189219
10884389189221
40884389189222
10193489040111
20193489040118
10193489021820
20193489021827

Recall #: Z-1563-2026. DBQ-GOWN,SURG,XALT,L4, CRTCL CVR or DBD-GOWN,SRG,PNL CVR configurations.

Product: Medline Surgical Drapes
Variants: Green, 60X70, 60X90, 28 X 50.5
Model / REF:
MDTBTCS6070GN
MDTBTCS6090GN
MDTDXUNDBGN
MDTMAYOXGN
MDTZ1003656GN
Lot Numbers:
All lots affected
UDI:
10193489036961
20193489036968
10193489036978
20193489036975
10193489040098
20193489040095
10193489036954
20193489036951
10193489036985
20193489036982

Recall #: Z-1564-2026. Includes Table Covers, Underbuttock Drapes, Mayo Stand Covers, and Pocket Sheets.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98430
Status: Active
Manufacturer: Medline Industries, LP
Sold By: Hospitals; Surgical Centers; Medical Supply Distributors
Manufactured In: United States
Units Affected: 2 products (104,004; 23,568)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.