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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87434

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

Open FDA event record

Event summary

Timeline bucket
January 19, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Stryker Sustainability Solutions

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

Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures.

Z-1327-2021
Recall number
Z-1327-2021
Initiated
January 19, 2021
Classification
Class II
Status
Ongoing
Quantity
102 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was distributed without receiving regulatory clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product was distributed without receiving regulatory clearance.

Code information

Catalog Number: HARH36 GTIN: 07613327346251 Lot Number: 12444050

Distribution pattern

Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.