Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported October 30, 2019
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036
It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the l…
Xintec Corp recalled OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fib… - a low-severity action.
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fib… was recalled by Xintec Corp in October 30, 2019. Reason: It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from t…. Check the official notice for the remedy. Verify recall #Z-0162-2020 with the FDA Devices before acting.
The recall
Xintec Corp issued this low-severity FDA Devices recall-It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from t….
- Low
- severity level
- Class III
- classification
- October 30, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0162-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0162-2020) was formally reported on October 30, 2019, with the manufacturer initiating the action on October 29, 2017. It is classified under Low severity (Class III), with a current status of Terminated. Xintec Corp is listed as the recalling firm, operating out of Alameda, CA. Federal records list the affected scope as 45 lasers.
The documented reason for this recall is: It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in. Distribution data in the federal record shows the product reached: PA and VA. 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
45 lasers
Related Recalls
6
3 from same agency
Product description
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036
Reason for recall
It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0162-2020 |
| Date reported | October 30, 2019 |
| Date initiated | October 29, 2017 |
| Recalling firm | Xintec Corp |
| Firm location | Alameda, CA |
| Affected scope | 45 lasers |
| Distribution | PA and VA |
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-0162-2020) 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? ▼
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036. Recalled by Xintec Corp. Units affected: 45 lasers.
Why was this product recalled? ▼
It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2019. Severity: Low. Recall number: Z-0162-2020.
Where was the recalled product distributed? ▼
Distribution: PA and VA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0162-2020) 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.
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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 October 30, 2019. 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.