Cub 2 Bed Canopy (Sensory Medical) – Warning Update (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cub 2 Enclosed Bed Canopy System
Brand
Sensory Medical Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model/Product Code - Cub2 UDI Code: None Serial Numbers: All device manufactured/distributed prior to 12/16/2021.
Sensory Medical Inc is recalling Cub 2 Enclosed Bed Canopy System due to Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.
Recommended Action
Per FDA guidance
On 03/14/2022, the firm, CUBBY, initiated calling its customers to inform them of an "URGENT-VOLUNTARY MEDICAL DEVICE CORRECTION" associated with Cubby Beds distributed between 02/24/2020 thru 12/16/2021 and the potential for the risk of misuse and possible entrapment. Between 03/15-16/2022, the firm mailed an URGENT VOLUNTARY MEDICAL DEVICE CORRECTION" Letter along with the updated Warnings & Precautions Booklet and new Product/User manuals. The Customer Notification Letter instructed customers to: 1. Identify/Locate Affected Product. Check their records and make sure that it is in fact a unit impacted by this voluntary medical device correction. 2. Add/Secure the Warning & Precautions Booklet to the Cubby Bed. 3. Locate, Remove, Destroy, and Update/Replace the Old Cubby Bed Product/User Manuals. First, locate the old/outdated product/user manuals from wherever it has been placed/stored. Destroy and discard this outdated product/user manuals in such a fashion so that it cannot be used in the future. Next, locate the updated product/user manuals that were provided with this Voluntary Medical Device Correction. Place and/or store these product/user manuals in an area close to/near the bed so they are readily available for use as needed. Ensure that anyone who provides patient care understands the content of these product/user manuals and knows where to find/locate them when needed. 5. Ensure Completion of All Steps & Completion of the Hardcopy or Online Verification Form. Double check and verify that all the steps outlined within the Steps for Voluntary Medical Device Correction have been properly completed/addressed. Should you have any questions or concerns about this correspondence, please contact, John Sawyer, Vice-President, Quality Assurance and Regulatory Affairs at (855) 964-2664 or email at Hello@cubbybeds.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026