The Recall Desk
SevereFDA (Devices)·Z-0918-2022·Announced 2022-04-20

Cub 2 Enclosed Bed Canopy System Recalled Due to Potential Misuse

Sensory Medical Inc recalled 225 units of the Cub 2 Enclosed Bed Canopy System for potential misuse risk. The firm is updating product warnings and precautions for devices distributed before December 16, 2021.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I medical device classification indicates serious potential for harm. The governing rule requires FDA Class I recalls to receive a minimum severity score of 4. Although no illnesses, injuries, or deaths have been reported and the specific misuse hazard remains unspecified in the source, the official Class I designation by FDA reflects serious risk.

Plain-English summary

Sensory Medical Inc is recalling approximately 225 units of the Cub 2 Enclosed Bed Canopy System due to potential misuse of the product. The recall affects devices manufactured and distributed prior to December 16, 2021.

In response to the identified risk, the firm is updating the warnings and precautions booklet that accompanies the device. These updated materials provide clarified guidance intended to prevent the potential misuse and mitigate associated risks.

The recalled devices were distributed nationwide across the United States and internationally to Canada. Patients, caregivers, and healthcare facilities using these devices should obtain and review the updated warnings and precautions materials from the manufacturer to ensure safe use.

The recalled product

Product
Cub 2 Enclosed Bed Canopy System
Manufacturer
Sensory Medical Inc
Category
Medical Device
Hazard
Affected units
225

Distribution

Distributed nationwide across the United States.

The notice also names 41 states specifically:

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