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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 INDUSTRIES, LP - Northfield: Surgical Gowns Recalled for Incorrect Sleeve Construction

Agency Publication Date: January 11, 2024
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Summary

Medline Industries is recalling 2,100 Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gowns) because they were manufactured with the wrong sleeves. These non-sterile, poly-reinforced gowns are used in medical settings to protect healthcare workers and patients. Consumers who have these specific gowns should check their supplies immediately and contact the manufacturer for guidance on affected units.

Risk

The use of a gown with incorrect sleeves may compromise the intended fluid protection levels (AAMI Level 4), potentially exposing healthcare staff or patients to fluids, microorganisms, and infectious materials during surgical procedures.

What You Should Do

  1. Locate any Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown) in your inventory and check for Product Reference (REF) SPT-2208CS.
  2. Identify affected units by checking for Lot Number 11023060120 and UDI code (01)40080196029755(11)230615(10)11023060120.
  3. Immediately set aside any gowns matching these identifiers to ensure they are not used in surgical or clinical settings.
  4. Contact your healthcare provider or Medline Industries directly at 1-800-MEDLINE (1-800-633-5463) or via their website at www.medline.com for further instructions and potential product return or refund information.
  5. For additional questions or to report a problem, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), 100/pack
Model / REF:
REF SPT-2208CS
UPC Codes:
40080196029755
Lot Numbers:
11023060120

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93560
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Manufactured In: United States
Units Affected: 2,100 gowns
Distributed To: Maryland, Ohio, Tennessee, Texas, Wisconsin

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.