Exact FDA event identifier

Event 94999

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

Open FDA event record

Event summary

Timeline bucket: June 17, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
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 Kit containing the Microtek decanter

Z-2685-2024

Recall number: Z-2685-2024
Initiated: June 17, 2024
Classification: Class II
Status: Ongoing
Recalling firm: ROi CPS LLC
Quantity: 78 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.

Code information

Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)

Distribution pattern

US Nationwide distribution in the state of MO.