Z-0918-2022Class I

Cub 2 Enclosed Bed Canopy System

Name: Z-0918-2022 Cub 2 Enclosed Bed Canopy System
Creator: Sensory Medical Inc
Published: 2022-03-14
License: https://open.fda.gov/license/

Sensory Medical Inc / initiated 2022-03-14 / Open, Classified / root cause: labeling and UDI

FDA source

Sensory Medical Inc began a recall of Cub 2 Enclosed Bed Canopy System on 2022-03-14. FDA classified it as Class I and gives the reason as "Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0918-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-03-14
Posted: 2022-04-14
Recalling firm: Sensory Medical Inc
Product: Cub 2 Enclosed Bed Canopy System
Product code: OYS Patient Bed With Canopy/Restraints
Reason for recall: Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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 First, locate the old/outdated product/user manuals from wherever it has been placed/stored. Destroy and discard this outdated product/user manuals in such a fashion so that it cannot be used in the future.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 [email protected].
Quantity in commerce: 225 devices
Distribution: U.S. Nationwide distribution to states including: AK, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA. MD, MI, MN, MO. MS. NC, ND, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, and WI; and O.U.S Internationally to: Canada
Product codes and lots: Model/Product Code - Cub2 UDI Code: None Serial Numbers: All device manufactured/distributed prior to 12/16/2021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0918-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0918-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-14

Product code OYS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)