FDA Device recall Z-2355-2021
HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desir…
- FDA Device
- Class II
- ongoing
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class II recall of HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desir… by Ethicon Endo Surgery, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2355-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-07-20 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ethicon Endo Surgery |
| Distribution | US |
Product
HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20
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
Identifiers
| code_info | Lot Codes: U95126 U9571N U9526Z U95A80 U9543P U95T0X U9550G GTIN: 10705036015048 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2355-2021%22
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