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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80066

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

Open FDA event record

Event summary

Timeline bucket
May 03, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
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 ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are 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) and other open and endoscopic procedures.

Z-2048-2018
Recall number
Z-2048-2018
Initiated
May 03, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon Endo-Surgery Inc
Quantity
25657

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

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

The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

Code information

P9125C, P93T5J, P93T5K, P93V06, P93W4Y, P93Y4A, P93W8A, P9400F, P9409V, P94A93, P94A94, P94C8R, P94G1W, P91F4A, P91F86, P93M3W, P93W0A, P93Z4X, P93Z96, P94E6U, P94H32, P94H9V, P94J28

Distribution pattern

Worldwide distribution - US Nationwide. The devices were distributed to the following foreign countries: Algeria, Angola, Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, UK, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mayotte, Mexico, Mongolia, Montenegro, Morocco, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, UAE, Uruguay, Vietnam.

device · product 2 of 2

HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are 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) and other open and endoscopic procedures.

Z-2049-2018
Recall number
Z-2049-2018
Initiated
May 03, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon Endo-Surgery Inc
Quantity
146,326

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

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

The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

Code information

N93923, N9392K, N93978, P9123A, P9129W, P91301, P91394, P9139N, P9144R, P9149J, P9148K, P9168K, P9173R, P9174K, P91795, P91C51, P91C83, P91D30, P91K68, P91L0H, P91K69, P91L0J, P91L1Y, P91L6E, P91L6J, P9396A, P9396C, P9399T, P93A1L, P93M0K, P93M0L, P93N01, P93M5Y, P93N5A, P93N3X, P93N3Y, P93P09, P93P26, P93P7H, P93R10, P93R4F, P93R4G, P93R56, P93R6V, P93T0X, P93T9L, P93T9M, P93U17, P93U91, P93V0V, P93V0W, P93V5T, P93V02, P93V03, P93X4E, P93X65, P93X85, P93X98, P93X9E, P93Y47, P93Y48, P93Y8X, P93X2X, P93Z95, P93Z4T, P93Z5X, P94015, P9405H, P9409W, P9410Z, P9414T, P94A5K, P94A6A, P94C11, P94C47, P94C5R, P94C8T, P94D3J, P94D3K, P94D5G, P94D7Z, P94D9K, P94E1Z, P94E20, P94E3Z, P94E8W, P94F1M, P94F3A, P94F5T, P94F6C, P94F7L, P94G1G, P94G1H, P94G1J, P94H0J, P94H0K, P94H31, P94H4V, P94H8J, P9139V, P91749, P9179U, P91F2X, P91L1Z, P93L47, P93L76, P93M6T, P93M6P, P93N00, P93N7G, P93N7H, P93P2E, P93P7G, P93R0Z, P93R57, P93R6U, P93T20, P93T26, P93U0P, P93U5N, P93U90, P93V57, P93W9X, P93X2G, P93W9R, P93X2W, P94C10, P94D0M, P94D0P, P94J29

Distribution pattern

Worldwide distribution - US Nationwide. The devices were distributed to the following foreign countries: Algeria, Angola, Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, UK, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mayotte, Mexico, Mongolia, Montenegro, Morocco, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, UAE, Uruguay, Vietnam.