Safety Alert: Class I: Potential for undetected, deformed a-traumatic tips.
healthClass IRecalled on Sep 17, 2025
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:
🔢 103,731 units
Sold At: Olympus Corporation of the Americas(Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.)
Recall #: FDA-DEVICE-Z-2484-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Model Number: NA-U403SX-4019. UDI-DI: 00821925043060. All lots distributed between August 4, 2022 and April 25, 2025
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Summary
Potential for undetected, deformed a-traumatic tips.
What to do next
- 1URGENT: Stop using this product immediately - serious health hazard
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Olympus Corporation of the Americas for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.