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Unrated Medical device recall · FDA · Published February 19, 2022

Ansell Healthcare Recalls Surgical Gloves Due to FDA Inspection Failure

Ansell Healthcare recalls specific surgical gloves for failing to stop at border for FDA inspection. This may affect medical use safety.

🇺🇸 FDA recall #Z-0838-2022Medical deviceAnsell Healthcare ›
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Recalling firmAnsell Healthcare Products LLC2301 Robb Dr · Reno, NV 89523-1901
✎ GovInfoNow plain-language explainer

Ansell Healthcare is recalling certain surgical gloves because a transport company did not stop at the border for required FDA inspection. This could impact medical safety if the gloves are used without proper regulatory checks. Read more at govinfonow.com/recall/61126-ansell-healthcare-recalls-surgical-gloves-due-to-fda-inspection-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/61126-ansell-healthcare-recalls-surgical-gloves-due-to-fda-inspection-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0838-2022

Cite this page

“Ansell Healthcare Recalls Surgical Gloves Due to FDA Inspection Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61126-ansell-healthcare-recalls-surgical-gloves-due-to-fda-inspection-failure. Based on FDA recall #Z-0838-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0838-2022%22&limit=1).

The FDA announced on Feb. 19, 2022, that Ansell Healthcare Products LLC is recalling Gammex Non-Latex PI Green surgical gloves because a transport company failed to stop for required FDA inspection. The agency did not provide a remedy in this record.

How to tell if you have it

  • Brand: Ansell Healthcare
  • Product: Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
  • Model Number: 20685275
  • UDI Code: 00884792385244
  • Lot Number: 2107481604
  • Quantity: 74 cases
  • Sold in: U.S. states AZ, CA, NV, TX, UT and WA

The hazard

The recall was initiated because a transport company failed to stop at the border for required FDA inspection, according to the FDA record.

Context

GovInfoNow's records show Ansell Healthcare Products LLC has two other recalls on file since Aug. 19, 2020. On Aug. 3, 2023, the company recalled PI Green Surgical Gloves due to unsealed sterile pouches. Other recent recalls of similar products include Performance Pro Blue Nitrile Gloves Recall (Aug. 14, 2026), Becton Dickinson Spinal Tray Recall (April 27, 2026) and Medline Convenience Kits Recall (May 6, 2026).

How to tell if you have this one

Check for the model number 20685275, UDI code 00884792385244, and lot number 2107481604 on the gloves. These items were sold with the specific product description.

  • Brand
    Ansell Healthcare
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the model number 20685275, UDI code 00884792385244, and lot number 2107481604 on the gloves.

Where it went and when

Where it was distributed

Distributed in 6 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: yesUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Nevada, Texas, Utah, Washington.

Recall timeline

FDA published this recall 46 days after the firm started it.

1. Firm started the recall: Feb 19, 202212. FDA classified it Class II: Mar 30, 202223. Published in FDA’s Enforcement Report: Apr 6, 202232022
  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.

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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-0838-2022 (February 19, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0838-2022 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