Recall Z-2356-2021— Ethicon Endo-Surgery Inc

Name: FDA recall Z-2356-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-20

Class II · Ongoing

Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2021-07-20. It names one FDA 510(k) clearance: K191555. Product: HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36. Reason: 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.

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-07-20
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K191555 — HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm lengthEthicon Endo-Surgery, LLC·cleared 2020-02-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.