FDA Device recall Z-0838-2022
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
- FDA Device
- Class II
- ongoing
- Published 2022-04-06
On 2022-04-06 the FDA classified a Class II recall of Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 by Ansell Healthcare Products, citing transport company failed to stop at the border for required FDA inspection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0838-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-19 |
| Published | 2022-04-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ansell Healthcare Products |
| Distribution | AZ, CA, NV, TX, UT, WA |
Product
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Reason
Transport company failed to stop at the border for required FDA inspection.
Identifiers
| code_info | Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Ansell Healthcare Products
- NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
FDA Device · Class II · 2023-10-18 · Ansell Healthcare Products - GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
FDA Device · Class II · 2023-10-18 · Ansell Healthcare Products - MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical…
FDA Device · Class II · 2020-10-14 · Ansell Healthcare Products - Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd
FDA Device · Class II · 2016-12-28 · Ansell Healthcare Products - LifeStyles ZERO 10 uber-thin lubricated latex condoms
FDA Device · Class II · 2013-02-27 · Ansell Healthcare Products
All Ansell Healthcare Products recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0838-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.