Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88434

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 20, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ethicon Endo-Surgery 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

2 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 2

HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20

Z-2355-2021
Recall number
Z-2355-2021
Initiated
July 20, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Ethicon Endo-Surgery Inc
Quantity
7870 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns

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

An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns

Code information

Lot Codes: U95126 U9571N U9526Z U95A80 U9543P U95T0X U9550G GTIN: 10705036015048

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Austria, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates.

device · product 2 of 2

HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36

Z-2356-2021
Recall number
Z-2356-2021
Initiated
July 20, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Ethicon Endo-Surgery Inc
Quantity
68960 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns

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

An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns

Code information

Lot Codes: U94Y9V U95C2A U94Z98 U95427 U9516E U95599 U9503G U95856 U94Y9W U95L0A U9518D U95526 U9507E U9548R U95127 U95525 U9530P U95T2Z U95366 U95R4F U9521Z U95F2T U9554U U95F8W U9564G U95U6A U95524 U95E6F U9512D U95K4D U94Z49 U95F07 U95A9X U95F6N U9569W U95E1U U9571P U95E72 U9587D U95E29 U95815 U95T90 U95814 U95Z67 U95754 U95Y7G U95D4T U9523L U95566 U9530X U9543R GTIN: 10705036015055

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Austria, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates.