Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

FDA Device Recall #Z-0838-2022 — Class II — February 19, 2022

Recall Summary

Recall Number Z-0838-2022
Classification Class II — Moderate risk
Date Initiated February 19, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ansell Healthcare Products LLC
Location Reno, NV
Product Type Devices
Quantity 74 cases

Product Description

Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

Reason for Recall

Transport company failed to stop at the border for required FDA inspection.

Distribution Pattern

U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None

Lot / Code Information

Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604

Other Recalls from Ansell Healthcare Products LLC

Recall # Classification Product Date
Z-0097-2024 Class II NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical glo... Aug 3, 2023
Z-0096-2024 Class II GAMMEX NON-LATEX PI GREEN Surgical gloves, REF:... Aug 3, 2023
Z-0051-2021 Class II MICROFLEX Diamond Grip Examination Gloves, MF-3... Aug 19, 2020
Z-0893-2017 Class II Gammex Non-Latex Sensitive Neoprene Surgical ... Oct 24, 2016
Z-0838-2013 Class II LifeStyles ZERO 10 uber-thin lubricated latex c... Jan 14, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.