Elevated risk U.S. Food and Drug Administration

Olympus ViziShot 2 Flex Ebus -Tbna needles recall: Device & Drug Safety - Defect

Recall published 10 months ago

Device & Drug Safety - Defect

The hazard: Potency, impurity or stability failure

The recall concerns the strength or purity of the medicine rather than contamination of it, which changes what you should do about a dose you have already taken.

What the notice says: The device heat-shrink material that seals the needle can degrade during clinical use and may result in difficulty in extracting or expelling samples, fluid leakage, impaired needle deployment or retraction, or breakage of device components.

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
January 16, 2026
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Olympus
Product type
Medical devices

Products covered by this recall

ViziShot 2 FLEX (19G) EBUS -TBNA needles

What the company announced

CENTER VALLEY, Pa., (January 16, 2026) — Olympus Corporation has announced the expansion of a previous global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) after receiving and investigating complaints of device components ejecting or detaching during procedures. The complaints included adverse event reports of patient injury and one death. This expanded action includes all lots of the ViziShot 2 FLEX needles and supersedes the August 2025 notice in which only certain lots of the device were being recalled.

Potential consequences of a detached component of the ViziShot 2 FLEX include the risk of unintended device components within the tracheobronchial tree that may require bronchoscopic extraction or surgical removal.

Since the August 2025 notice, internal investigations of complaints identified additional contributing factors to hypotube component ejection including device heat-shrink material degradation and use errors, which affect all lots of the ViziShot 2 FLEX device. The device heat-shrink material that seals the needle can degrade during clinical use and may result in difficulty in extracting or expelling samples, fluid leakage, impaired needle deployment or retraction, or breakage of device components.

Users are directed to cease use immediately and quarantine all ViziShot 2 FLEX devices. Customers have been instructed to return the affected devices to Olympus by following the instructions provided in the removal action communication. Patient safety is our top priority.

The ViziShot 2 FLEX is designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration and fine needle biopsy of submucosal and extramural lesions of the tracheobronchial tree.

Other EBUS-TBNA needles are not affected by this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch program online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda .

For information on how to identify affected product, U.S. customers can contact the Olympus Technical Assistance Center (TAC) at 1-800-848-9024, Option 1, Monday-Friday between 7:00 AM and 8:00 PM ET. U.S. customers can report a problem with the device to TAC by phone, or by email at [email protected] .

For information on how to identify affected product, U.S. customers can contact the Olympus Technical Assistance Center (TAC) at 1-800-848-9024, Option 1, Monday-Friday between 7:00 AM and 8:00 PM ET. U.S. customers can report a problem with the device to TAC by phone, or by email at [email protected] .

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

What to do about Potency

Olympus — The recall concerns the strength or purity of the medicine rather than contamination of it, which changes what you should do about a dose you have already taken.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.
  3. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.
  4. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Olympus Corporation — Consumers: Olympus Technical Assistance Center (TAC), 1-800-848-9024, Option 1, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Olympus medical devices recalled?

Device & Drug Safety - Defect The device heat-shrink material that seals the needle can degrade during clinical use and may result in difficulty in extracting or expelling samples, fluid leakage, impaired needle deployment or retraction, or breakage of device components.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

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