Olympus Corporation of the Americas medical device recall: ViziShot 2FLEX. Single Use Aspiration Needle. Model Number:…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97303
- Recall initiated
- Aug 6, 2025
- Classified by FDA
- Sep 5, 2025
- Posted in Enforcement Report
- Sep 17, 2025
- Recalling firm
- Olympus Corporation of the Americas
- Firm location
- Center Valley, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Potential for undetected, deformed a-traumatic tips.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Aug 6, 2025. FDA classified it 30 days later, on Sep 5, 2025. Distribution reported by FDA: Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore. Olympus Corporation of the Americas has 145 recalls in our records.
Recalled products (1)
Z-2484-2025 Class I Ongoing
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube.
Codes / lots: Model Number: NA-U403SX-4019. UDI-DI: 00821925043060. Lot numbers: All lots manufactured after 7/29/2022.
Quantity: 104,508 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97303
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.