Exact FDA event identifier

Event 80074

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

Open FDA event record

Event summary

Timeline bucket: November 06, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Southmedic, 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

Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.

Z-1892-2018

Recall number: Z-1892-2018
Initiated: November 06, 2017
Classification: Class II
Status: Terminated
Recalling firm: Southmedic, Inc.
Quantity: 3,300 scalpels

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

non-sterile products labeled as sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scalpels lot contains non-sterile products labeled as sterile.

Code information

Part Number 73-0115 Lot Number 092517

Distribution pattern

US Distribution to the states of : IA, IL, NE, NY and TX