Sensory Medical Inc recalls Cub 2 Enclosed Bed Canopy System

Recall date

March 14, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0918-2022

FDA classification

Class I

Brand / firm

Sensory Medical Inc

Sold / distributed

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

Why it was recalled

Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Cub 2 Enclosed Bed Canopy System