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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89149

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

Open FDA event record

Event summary

Timeline bucket
November 30, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ROi CPS LLC

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

Regard, T AND A - Rogers, sterilized convenience kits

Z-0469-2022
Recall number
Z-0469-2022
Initiated
November 30, 2021
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
195 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Kits lacks rubber latex warning label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kits lacks rubber latex warning label.

Code information

1) Item Number 8800313004, Lot Number 89090D (UDI 10194717110804); Expiration 07/15/2023 2) Item Number 8800313005, Lot Number 89378 (UDI 10194717112730); Expiration 08/05/2023

Distribution pattern

US Nationwide distribution in the state of MO.