Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 27, 2014
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.
Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Hyperion Medical recalled All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, incl… - a moderate-severity action.
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, incl… was recalled by Hyperion Medical in August 27, 2014. Reason: Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cl…. Check the official notice for the remedy. Verify recall #Z-2264-2014 with the FDA Devices before acting.
The recall
Hyperion Medical issued this moderate-severity FDA Devices recall-Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cl….
- Moderate
- severity level
- Class II
- classification
- August 27, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2264-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2264-2014) was formally reported on August 27, 2014, with the manufacturer initiating the action on November 20, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Hyperion Medical is listed as the recalling firm, operating out of Addison, TX. Federal records list the affected scope as 3,346 brochures. Quantity not applicable to web site..
The documented reason for this recall is: Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site and brochures had claims that it could … Distribution data in the federal record shows the product reached: US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.. 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
3,346 brochures. Quantity not applicable to web site.
Related Recalls
6
3 from same agency
Product description
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.
Reason for recall
Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site and brochures had claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, and a claim that the product could be used with a 15 mm hand piece.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2264-2014 |
| Date reported | August 27, 2014 |
| Date initiated | November 20, 2013 |
| Recalling firm | Hyperion Medical |
| Firm location | Addison, TX |
| Affected scope | 3,346 brochures. Quantity not applicable to web site. |
| Distribution | US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA. |
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-2264-2014) 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? ▼
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.. Recalled by Hyperion Medical. Units affected: 3,346 brochures. Quantity not applicable to web site..
Why was this product recalled? ▼
Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site and brochures had claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, and a claim that the product could be used with a 15 mm hand piece.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 27, 2014. Severity: Moderate. Recall number: Z-2264-2014.
Where was the recalled product distributed? ▼
Distribution: US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2264-2014) 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 August 27, 2014. 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.