RecallRadar

FDA Device recall Z-0097-2024

NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290

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

AgencyFDA Device
Recall numberZ-0097-2024
ClassificationClass II
Statusongoing
Initiated2023-08-03
Published2023-10-18
Last updated2026-09-13 11:56 UTC
CompanyAnsell Healthcare Products
DistributionUS

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.

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.