GAMMEX NON-LATEX PI GREEN Surgical Gloves with Unsealed Sterile Pouches
Ansell is recalling GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Approximately 1,511 units were distributed nationwide across multiple states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving surgical gloves with improper sterile packaging. While no illnesses or injuries have been reported, unsealed sterile pouches create a risk of contamination for surgical applications. Per the rubric, this qualifies as 'risk-of-harm products where injury has not yet been reported,' resulting in a High score.
Plain-English summary
Ansell Healthcare Products LLC is recalling GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. The affected gloves have reference numbers 20685255 through 20685290.
Approximately 1,511 units were distributed nationwide, including to Indiana, Ohio, New York, Virginia, Illinois, Tennessee, Georgia, South Carolina, Wisconsin, and Florida, as well as Canada. The affected lot is 2203434204.
Healthcare facilities should verify the lot numbers and reference numbers of their GAMMEX NON-LATEX PI GREEN gloves. If your facility has received gloves from the affected lot and reference numbers, contact Ansell Healthcare Products LLC to arrange for replacement or return of the product.
Surgical glove sterile pouches must remain sealed to maintain sterility during storage and use. Unsealed pouches may compromise the sterile protection that these gloves are intended to provide.
The recalled product
- Product
- GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
- Manufacturer
- Ansell Healthcare Products LLC
- Hazard
- improper-sealing
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot: 2203434204
- REF/UDI-DI: 20685255/00884792385206
- 20685260/00884792385213
- 20685265/00884792385220
- 20685270/00884792385237
- 20685275/00884792385244
- 20685280 00884792385251
- 20685285 00884792385268
- 20685290 00884792385275.
Distribution
Distributed nationwide across the United States.
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