CLASS II ONGOING Device recall · Reported 6 Apr 2022 · FDA Enforcement Report

Gammex Non-Latex PI Green Pi-kare Skin-friendly PI recalled

Ansell Healthcare Products is recalling Gammex Non-Latex PI Green Pi-kare Skin-friendly PI Technology polyisoprene surgical, distributed in Arizona, California, Nevada, Texas, Utah, Washington. The recall was initiated on 19 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604

Quantity recalled74 cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0838-2022
FDA event ID: 89691
Recalling firm: Ansell Healthcare Products, Reno, NV
Classification: Class II
Status: Ongoing
Recall initiated: 19 Feb 2022
FDA classified: 30 Mar 2022
Reported: 6 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Processing Deviation
Device type: Surgical Instruments

Timeline

19 Feb 2022	Recall initiated by company
30 Mar 2022	Classified by FDA	+39 days
6 Apr 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

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

Where it was distributed

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

Arizona California Nevada Texas Utah Washington

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ansell Healthcare Products

All 7

Reported	Class	Recall	Company	Reason	Where
18 Oct 2023Device	CLASS II	Gammex Non-latex PI Green Surgical gloves recalled	Ansell Healthcare Products	Sterility	Nationwide
18 Oct 2023Device	CLASS II	Novaplus Gammex Non-latex PI Green Surgical gloves recalled	Ansell Healthcare Products	Sterility	Nationwide
14 Oct 2020Device	CLASS II	Microflex Diamond Grip Examination Gloves, MF recalled	Ansell Healthcare Products	Other	Nationwide
28 Dec 2016Device	CLASS II	Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell recalled	Ansell Healthcare Products	Foreign Material	5 states
27 Feb 2013Device	CLASS II	LifeStyles ZERO 10 uber-thin lubricated latex condoms recalled	Ansell Healthcare Products	Device Malfunction	Nationwide

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