Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 6, 2020
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Boston Scientific Corporation recalled MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for th… - a moderate-severity action.
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for th… was recalled by Boston Scientific Corporation in May 6, 2020. Reason: To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which wil…. Check the official notice for the remedy. Verify recall #Z-1798-2020 with the FDA Devices before acting.
The recall
Boston Scientific Corporation issued this moderate-severity FDA Devices recall-To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which wil….
- Moderate
- severity level
- 147K units
- affected scope
- Class II
- classification
- May 6, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1798-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1798-2020) was formally reported on May 6, 2020, with the manufacturer initiating the action on March 30, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Boston Scientific Corporation is listed as the recalling firm, operating out of Marlborough, MA. Federal records list the affected scope as 146,633, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related comp… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and Global distribution.. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
146,633
Related Recalls
6
3 from same agency
Product description
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
Reason for recall
To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1798-2020 |
| Date reported | May 6, 2020 |
| Date initiated | March 30, 2020 |
| Recalling firm | Boston Scientific Corporation |
| Firm location | Marlborough, MA |
| Affected scope | 146,633 |
| Distribution | Worldwide distribution - US Nationwide and Global distribution. |
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-1798-2020) 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? ▼
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.. Recalled by Boston Scientific Corporation. Units affected: 146,633.
Why was this product recalled? ▼
To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2020. Severity: Moderate. Recall number: Z-1798-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and Global distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1798-2020) 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.
Nearby Recalls in This Category
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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 6, 2020. 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.