FDA Device recall Z-0097-2024
NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
- FDA Device
- Class II
- ongoing
- Published 2023-10-18
On 2023-10-18 the FDA classified a Class II recall of NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290 by Ansell Healthcare Products, citing some surgical glove sterile pouches were not completely sealed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0097-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-03 |
| Published | 2023-10-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ansell Healthcare Products |
| Distribution | US |
Product
NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
Reason
Some surgical glove sterile pouches were not completely sealed.
Identifiers
| code_info | Lot: 2203434604, REF/UDI-DI: V20685255/10014566400553, V20685260/10014566400607, V20685265/10014566400652, V20685270/1…Lot: 2203434604, REF/UDI-DI: V20685255/10014566400553, V20685260/10014566400607, V20685265/10014566400652, V20685270/10014566400706, V20685275/10014566400751, V20685280/10014566400805, V20685285/10014566400850, V20685290/10014566400904. |
|---|
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
- GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
FDA Device · Class II · 2023-10-18 · Ansell Healthcare Products - Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
FDA Device · Class II · 2022-04-06 · 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-0097-2024%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.