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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89707

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 14, 2022
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Sensory Medical Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Cub 2 Enclosed Bed Canopy System

Z-0918-2022
Recall number
Z-0918-2022
Initiated
March 14, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Sensory Medical Inc
Quantity
225 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model/Product Code - Cub2 UDI Code: None Serial Numbers: All device manufactured/distributed prior to 12/16/2021.

Distribution pattern

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