Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79668

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

Open FDA event record

Event summary

Timeline bucket
March 07, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ethicon, 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

Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.

Z-1534-2018
Recall number
Z-1534-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
738 devices (246 boxes of 3)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products labeled for distribution outside the United States may have been distributed to customers in the United States.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled for distribution outside the United States may have been distributed to customers in the United States.

Code information

Lot 17-0102

Distribution pattern

The device was distributed to the following states: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TN, TX, WA, WI, and WV. The device was also distributed to Puerto Rico.

Field note

Send feedback

We'll only use this to respond to your feedback.