Class I — Sensory Medical Inc
| Recalling firm | Sensory Medical Inc |
|---|---|
| Registered facility | SENSORY MEDICAL INC (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021. |
| Product | Cub 2 Enclosed Bed Canopy System |
| Quantity | 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 |
| Initiated | 2022-03-14 |
| Classified | 2022-04-14 |
| Recall number | Z-0918-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Sensory Medical Inc (Z-0918-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89707/
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