Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported April 20, 2022
Cub 2 Enclosed Bed Canopy System
Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.
Sensory Medical Inc recalled Cub 2 Enclosed Bed Canopy System - a critical-severity action.
Cub 2 Enclosed Bed Canopy System was recalled by Sensory Medical Inc in April 20, 2022. Reason: Due potential misuse of the product, firm is updating warnings and precautions booklet for products distribut…. Check the official notice for the remedy. Verify recall #Z-0918-2022 with the FDA Devices before acting.
The recall
Sensory Medical Inc issued this critical-severity FDA Devices recall-Due potential misuse of the product, firm is updating warnings and precautions booklet for products distribut….
- Critical
- severity level
- 225 units
- affected scope
- Class I
- classification
- April 20, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0918-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0918-2022) was formally reported on April 20, 2022, with the manufacturer initiating the action on March 14, 2022. It is classified under Critical severity (Class I), with a current status of Ongoing. Sensory Medical Inc is listed as the recalling firm, operating out of Lakewood, CO. Federal records list the affected scope as 225 devices.
The documented reason for this recall is: Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021. Distribution data in the federal record shows the product reached: 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; a…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
225 devices
Related Recalls
6
6 from same agency
Product description
Cub 2 Enclosed Bed Canopy System
Reason for recall
Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0918-2022 |
| Date reported | April 20, 2022 |
| Date initiated | March 14, 2022 |
| Recalling firm | Sensory Medical Inc |
| Firm location | Lakewood, CO |
| Affected scope | 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 Internation… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0918-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Cub 2 Enclosed Bed Canopy System. Recalled by Sensory Medical Inc. Units affected: 225 devices.
Why was this product recalled? ▼
Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2022. Severity: Critical. Recall number: Z-0918-2022.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0918-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 20, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.