Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A ...
FDA Device Recall #Z-0452-2024 — Class II — July 19, 2023
Recall Summary
| Recall Number | Z-0452-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 19, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | IHB OPERATIONS B.V. |
| Location | Zwolle |
| Product Type | Devices |
| Quantity | 1,497 |
Product Description
Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.
Reason for Recall
Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.
Distribution Pattern
US: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MB, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, WI, WV.
Lot / Code Information
UDI-DI: 10841736115951 (F110 SERIES), UDI-DI: 10841736115968 (F120 SERIES), UDI-DI: 10841736115975 (F130 SERIES), UDI-DI: 10841736116491 (F320 SERIES), UDI-DI: 10841736116545 (F330 SERIES), UDI-DI: 10841736116576 (F350 SERIES), UDI-DI: 10841736116590 (F410 SERIES), UDI-DI: 10841736116651 (F420 SERIES).
Other Recalls from IHB OPERATIONS B.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1663-2025 | Class II | Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount | Mar 27, 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.