The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0452-2024·Announced 2023-12-13

Ceiling-mounted equipment dispensers recalled for weakened suspension arm

IHB Operations is recalling Freedom Boom ceiling-mounted equipment dispensers due to weakened connection points on the suspension arm that could cause equipment failure. The defect affects 1,497 units distributed across multiple US states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with a known structural defect (weakened suspension arm connection) posing significant risk of equipment failure. No injuries or property damage have been reported, meeting the criteria for High severity as a risk-of-harm product without reported incidents.

Plain-English summary

IHB Operations B.V. is recalling Freedom Boom ceiling-mounted utilities and equipment dispensing systems. The affected models include F110, F120, F130, F320, F330, F350, F410, and F420 equipped with 42A Lightweight Spring Arms.

The recalled units have a weakened connection point on the adjustable suspension arm. This defect could potentially cause damage or a break in the suspension system, compromising the device's structural integrity and ability to safely support and dispense equipment from the ceiling.

Approximately 1,497 units have been distributed across multiple US states including Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.

Users of the affected equipment should contact IHB Operations B.V. for guidance regarding inspection, repair, or replacement options.

The recalled product

Product
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.
Manufacturer
IHB OPERATIONS B.V.
Category
Medical Device — Equipment Dispensing System
Hazard
Affected units
1,497

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • 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).

Distribution

Distributed in 36 states:

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