GAMMEX recallZ-0838-2022 · Ansell Healthcare Products LLC · initiated Feb 19, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ansell Healthcare Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Transport company failed to stop at the border for required FDA inspection.
FDA root cause category: Other
What the company is doing
On 02/19/2022, the Recalling Firm initiated notification via email to its Distribution partners and requested that they reach out to their end user customers. The Recalling Firm informed its customers that between February 2nd to 10th, 2022, it shipped Non-Latex surgical gloves with LOT Number 2107481604 and Manufacturing Date 2021-08-05 to some of its distributor partners. As a part of their warehouse inventory rebalancing procedures within North America, the product was transferred from their Canadian warehouse to one of their USA warehouses. When importing into the US, the freight forwarder inadvertently bypassed a required FDA inspection. After arriving at the USA warehouse, product was shipped prematurely. Customers/Distributors are asked to: 1. Search their system/inventory to identify if affected products are currently in their possession. A visual guide is provided to assist with identifying the impacted product. 2. If impacted products are found in their system/inventory, they are to return the impacted products back to the Recalling Firm, and replacements were be provided free of charge. For questions or assistance in returning the products, contact Customer Service at 1-855-868-5540 or email [email protected].
Recall details
- Recall number
- Z-0838-2022
- Status
- Open, Classified
- Initiated by the company
- Feb 19, 2022
- Recalling firm
- Ansell Healthcare Products LLC
- Quantity
- 74 cases
- Product code
- KGO
- FDA submissions
- K111139
- Distribution
- U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None
Product description
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Code information (models, lots, serial numbers)
Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- GAMMEX 20685275Ansell Healthcare Product · Surgeon'S Gloves2 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page