Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
FDA Device Recall #Z-2112-2025 — Class II — June 30, 2025
Recall Summary
| Recall Number | Z-2112-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 30, 2025 |
| Status | Ongoing |
| Voluntary | FDA Mandated |
Recalling Firm
| Firm | Beyond Laser Systems, LLC |
| Location | Austin, TX |
| Product Type | Devices |
| Quantity | 12 |
Product Description
Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
Reason for Recall
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
N/A
Other Recalls from Beyond Laser Systems, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2111-2025 | Class II | Laser light show projectors manufactured by BLS... | Jun 30, 2025 |
| Z-2113-2025 | Class II | Laser light show projectors manufactured by BLS... | Jun 30, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.