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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80999

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

Open FDA event record

Event summary

Timeline bucket
September 17, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sterilmed, 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

Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324

Z-0090-2019
Recall number
Z-0090-2019
Initiated
September 17, 2018
Classification
Class II
Status
Terminated
Recalling firm
Sterilmed, Inc.
Quantity
218 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet endotoxin requirements per product specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.

Code information

All lots with expiration dates prior to 2019-06-08 of the following: (a) Product Code STJ408309, GTIN 10888551044912 (b) Product Code STJ408310, GTIN 10888551044929 (c) Product Code STJ408324, GTIN 10888551044950

Distribution pattern

U.S. Nationwide distribution in the states of CA, CO, MN, and WA.