FDA Medical Device Recalls (openFDA)
Ansell Healthcare Products LLC: Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
- Recall number
- Z-0838-2022
- Recalling firm
- Ansell Healthcare Products LLC
- Product
- Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
- Status
- Open, Classified
- Initiated
- 2022-02-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- Transport company failed to stop at the border for required FDA inspection.
- Root cause
- Other
- Action
- 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 customersolutionsus@ansell.com.
- Quantity
- 74 cases
- Distribution
- U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None
- Lot, serial or model codes
- Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604
- 510(k) numbers
- ["K111139"]
- PMA numbers
- not on file
- Product code
- KGO
- Firm FEI
- 3011209798
- Firm city
- Reno
- Firm state
- NV
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28