Surgical Gloves Recalled Due to Missed FDA Border Inspection
Ansell is recalling Gammex Non-Latex PI Green surgical gloves (size 7 1/2) because the product was not submitted for required FDA inspection at the border. Distribution included Arizona, California, Nevada, Texas, Utah, and Washington.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II but no product defects, illnesses, or injuries have been reported. The issue is procedural—failure to undergo required FDA border inspection—making this a voluntary precautionary recall due to regulatory non-compliance.
Plain-English summary
Ansell Healthcare Products LLC is recalling Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves, size 7 1/2. The recall affects 74 cases with Lot Number 2107481604 and Model Number 20685275.
The recall was issued because the product shipment was not submitted for required FDA inspection at the border. A transport company failed to stop at the border for the mandatory inspection process, resulting in the product being distributed without verification of FDA compliance.
The affected product was distributed in the United States to Arizona, California, Nevada, Texas, Utah, and Washington.
Patients and healthcare facilities that received this product should contact Ansell Healthcare Products LLC or the FDA for guidance on appropriate action. Any adverse events related to this product should be reported to the FDA.
The recalled product
- Product
- Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
- Manufacturer
- Ansell Healthcare Products LLC
- Category
- Medical Device — Surgical Gloves
- Hazard
- regulatory-non-compliance
- inspection-failure
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 (1)
- Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604
Distribution
Distributed in 6 states:
- AZ
- CA
- NV
- TX
- UT
- WA
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