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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85486

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

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Event summary

Timeline bucket
April 10, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Uromedica 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

ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.

Z-1808-2020
Recall number
Z-1808-2020
Initiated
April 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Uromedica Inc.
Quantity
11 tool sets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.

Code information

Model 750041, Lot # UM00650

Distribution pattern

Nationwide distribution to the following states: CA, GA, FL, MI, and VA.