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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90548

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

Open FDA event record

Event summary

Timeline bucket
June 24, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Neotract 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

UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool

Z-1502-2022
Recall number
Z-1502-2022
Initiated
June 24, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Neotract Inc
Quantity
18,722 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is the potential that during implant deployment, the device may not properly deliver a implant.

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

There is the potential that during implant deployment, the device may not properly deliver a implant.

Code information

UDI/DI: 00814932020049 & 00814932020001; Lot #s: 73M2100393 73A2200670 73M2100394 73A2200671 73M2100395 73A2200672 73A2200012 73A2200673 73A2200013 73A2200674 73A2200014 73A2200832 73A2200221 73A2200841 73A2200222 73A2200859 73A2200223 73A2200905 73A2200224 73B2200116 73A2200225 73B2200466 73A2200226 73C2200567 73A2200473 New Lots added as of 08/01/2022: 73A2200834, 73C2200911, and 73C2201163

Distribution pattern

US: AK AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NY OH OK PA RI SC SD TN TX UT VA VT WI WV OUS: None

Field note

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