Skip to content
Lower risk Medical device recall · FDA · Published August 3, 2023

Ansell Healthcare Recalls Surgical Gloves Due to Unsealed Sterile Pouches

Ansell Healthcare recalls specific batches of non-latex surgical gloves for potential unsealed sterile pouches. Consumers should check product details to determine if affected and contact for remedy.

🇺🇸 FDA recall #Z-0097-2024Medical deviceAnsell Healthcare ›
Take action

Contact the company

Recalling firmAnsell Healthcare Products LLC2301 Robb Dr · Reno, NV 89523-1901
✎ GovInfoNow plain-language explainer

What happened, in plain English

Ansell Healthcare is recalling certain batches of non-latex surgical gloves because some sterile pouches weren't fully sealed. This could lead to contamination or infection if the gloves are exposed to air or moisture. Read more at govinfonow.com/recall/57542-ansell-healthcare-recalls-surgical-gloves-due-to-unsealed-sterile-pouches.

Source Summary by GovInfoNow · govinfonow.com/recall/57542-ansell-healthcare-recalls-surgical-gloves-due-to-unsealed-sterile-pouches · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0097-2024

Cite this page

“Ansell Healthcare Recalls Surgical Gloves Due to Unsealed Sterile Pouches.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57542-ansell-healthcare-recalls-surgical-gloves-due-to-unsealed-sterile-pouches. Based on FDA recall #Z-0097-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0097-2024%22&limit=1).

Why it’s dangerous

The sterile pouches weren't completely sealed, which could allow air or moisture to enter. This might cause contamination or infection if the gloves are exposed to the environment.

Who’s affected

Healthcare workers and others using these gloves for medical procedures may be affected. The risk is low as the issue involves pouch sealing, not direct harm from the gloves themselves.

How to tell if you have this one

Check for the product reference numbers V20685255 through V20685290 on the packaging. The lot numbers listed include 2203434604 and other specific identifiers.

  • Brand
    Ansell Healthcare
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA.
Recall numberProduct, codes & lotsQuantity
Z-0096-2024GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290; Lot: 2203434204, REF/UDI-DI: 20685255/00884792385206, 20685260/00884792385213, 20685265/00884792385220, 20685270/00884792385237, 20685275/00884792385244, 20685280 00884792385251, 20685285 00884792385268, 20685290 00884792385275.1511
Z-0097-2024NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290; Lot: 2203434604, REF/UDI-DI: V20685255/10014566400553, V20685260/10014566400607, V20685265/10014566400652, V20685270/10014566400706, V20685275/10014566400751, V20685280/10014566400805, V20685285/10014566400850, V20685290/10014566400904.378
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the product reference numbers V20685255 through V20685290 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 10 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Georgia, Illinois, Indiana, New York, Ohio, South Carolina, Tennessee, Virginia, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Aug 3, 202312. FDA classified it Class II: Oct 11, 202323. Published in FDA’s Enforcement Report: Oct 18, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0097-2024 (August 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0097-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA