Severity
Low
LowClass IIIOngoing
FDA Devices recall · Reported May 31, 2023
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during nee…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Olympus Corporation of the Americas recalled ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for u… - a low-severity action.
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for u… was recalled by Olympus Corporation of the Americas in May 31, 2023. Reason: Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and …. Check the official notice for the remedy. Verify recall #Z-1615-2023 with the FDA Devices before acting.
The recall
Olympus Corporation of the Americas issued this low-severity FDA Devices recall-Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and ….
- Low
- severity level
- Class III
- classification
- May 31, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1615-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1615-2023) was formally reported on May 31, 2023, with the manufacturer initiating the action on March 31, 2023. It is classified under Low severity (Class III), with a current status of Ongoing. Olympus Corporation of the Americas is listed as the recalling firm, operating out of Center Valley, PA. Federal records list the affected scope as 2058 (Boxes; 5 per Box).
The documented reason for this recall is: Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction. Distribution data in the federal record shows the product reached: Natiowide Foreign: Canada, Germany. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2058 (Boxes; 5 per Box)
Related Recalls
6
3 from same agency
Product description
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
Reason for recall
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-1615-2023 |
| Date reported | May 31, 2023 |
| Date initiated | March 31, 2023 |
| Recalling firm | Olympus Corporation of the Americas |
| Firm location | Center Valley, PA |
| Affected scope | 2058 (Boxes; 5 per Box) |
| Distribution | Natiowide Foreign: Canada, Germany |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1615-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A. Recalled by Olympus Corporation of the Americas. Units affected: 2058 (Boxes; 5 per Box).
Why was this product recalled? ▼
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2023. Severity: Low. Recall number: Z-1615-2023.
Where was the recalled product distributed? ▼
Distribution: Natiowide Foreign: Canada, Germany.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1615-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 31, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.