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Stop using now Medical device recall · FDA · Published August 3, 2021

Olympus Arc Endocuff Vision: Packaging Seal Defect Risk of Patient Infection

Olympus recalls Arc Endocuff Vision devices with packaging seal defects that may allow bacterial contamination and patient infection. Affected models include specific sizes and lot numbers.

🇺🇸 FDA recall #Z-2423-2021Medical deviceOlympus ›
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Contact the company

Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy, PO Box 610 · Center Valley, PA 18034-0610
✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling Arc Endocuff Vision endoscopic accessories due to a packaging seal defect that could lead to patient infections. This is a serious safety issue requiring immediate attention from users. Read more at govinfonow.com/recall/62088-olympus-arc-endocuff-vision-packaging-seal-defect-risk-of-patient.

Source Summary by GovInfoNow · govinfonow.com/recall/62088-olympus-arc-endocuff-vision-packaging-seal-defect-risk-of-patient · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2423-2021

Cite this page

“Olympus Arc Endocuff Vision: Packaging Seal Defect Risk of Patient Infection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62088-olympus-arc-endocuff-vision-packaging-seal-defect-risk-of-patient. Based on FDA recall #Z-2423-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2423-2021%22&limit=1).

Why it’s dangerous

The packaging seal defect can breach the sterile barrier, allowing bacteria to enter the device. This increases the risk of patient infections during medical procedures.

Who’s affected

Users of Arc Endocuff Vision devices for endoscopic procedures are affected. Patients and medical professionals using the recalled models are at risk of infection.

How to tell if you have this one

Check for the model numbers ARV110 (M Blue), ARV120 (L Green), ARV130 (S Purple), or ARV140 (XL Orange) with specific lot numbers listed in the recall notice.

  • Brand
    Olympus
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Now

    Immediately stop using the recalled Arc Endocuff Vision devices as they pose a risk of patient infection.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

1. Firm started the recall: Aug 3, 202112. FDA classified it Class II: Sep 3, 202123. Published in FDA’s Enforcement Report: Sep 15, 202134. FDA terminated the recall: Jan 10, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

How can I check if my device is recalled?

Check the model number and lot number on your device against the list provided in the recall notice.

What should I do if I have a recalled device?

Immediately stop using the device and contact Olympus Corporation of the Americas for further instructions.

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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-2423-2021 (August 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2423-2021 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