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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

Ansell Healthcare Products LLC: GAMMEX Surgical Gloves Recalled for Incomplete Sterile Pouch Seals

Agency Publication Date: October 11, 2023
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Summary

Ansell Healthcare Products LLC is recalling approximately 1,889 units of GAMMEX and NOVAPLUS GAMMEX Non-Latex PI Green surgical gloves because some of the sterile pouches were not completely sealed. This defect means the gloves may no longer be sterile, which can lead to infections during medical procedures. These surgical gloves were distributed nationwide across 11 states and internationally to Canada.

Risk

A compromised seal on a sterile pouch allows bacteria and other contaminants to enter, potentially causing serious infections for patients or healthcare providers during surgery. While no specific injuries have been reported in this data, a non-sterile glove in a surgical environment poses a significant health risk.

What You Should Do

  1. Check your inventory for GAMMEX NON-LATEX PI GREEN surgical gloves with the following identifiers: Lot number 2203434204 and reference numbers 20685255 through 20685290.
  2. Check your inventory for NOVAPLUS GAMMEX NON-LATEX PI GREEN surgical gloves with the following identifiers: Lot number 2203434604 and reference numbers V20685255 through V20685290.
  3. Verify the UDI-DI on the packaging matches the affected codes, such as 00884792385206, 10014566400553, or others listed in the product details.
  4. Stop using any gloves from the affected lots immediately to prevent the risk of infection.
  5. Contact your healthcare provider or Ansell Healthcare Products LLC at their Reno, Nevada facility for further instructions on returning the product and obtaining a refund or replacement.
  6. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact the manufacturer regarding compromised sterile packaging.

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

Affected Products

Product: GAMMEX NON-LATEX PI GREEN Surgical gloves
Model / REF:
20685255
20685260
20685265
20685270
20685275
20685280
20685285
20685290
UPC Codes:
00884792385206
00884792385213
00884792385220
00884792385237
00884792385244
00884792385251
00884792385268
00884792385275
Lot Numbers:
2203434204
Product: NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves
Model / REF:
V20685255
V20685260
V20685265
V20685270
V20685275
V20685280
V20685285
V20685290
UPC Codes:
10014566400553
10014566400607
10014566400652
10014566400706
10014566400751
10014566400805
10014566400850
10014566400904
Lot Numbers:
2203434604

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93045
Status: Active
Manufacturer: Ansell Healthcare Products LLC
Sold By: Medical distributors; Hospitals; Surgical centers
Manufactured In: United States
Units Affected: 2 products (1511; 378)
Distributed To: Indiana, Ohio, New York, Virginia, Illinois, Tennessee, Georgia, South Carolina, Wisconsin, Florida

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.