Ethicon Endo-Surgery Inc HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Ethicon Endo-Surgery Inc
Lot Codes / Batch Numbers
Lot Codes: U95126 U9571N U9526Z U95A80 U9543P U95T0X U9550G GTIN: 10705036015048
Products Sold
Lot Codes: U95126 U9571N U9526Z U95A80 U9543P U95T0X U9550G GTIN: 10705036015048
Ethicon Endo-Surgery Inc is recalling HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding contr due to An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may resu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Ethicon issued Urgent Medical Device Removal letter to Operating Room Supervisors, Materials Management Personnel, and Chief of Surgery, on July 20, 2021. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email it to Stericycle at 877-884-7828 or Ethicon7616@stericycle.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 5. Customers are required to return unused affected HARMONIC HD 1000i Shears subject to this recall that are in their inventory immediately. To receive replacement reimbursement, customers must return product subject to this recall no later than October 31, 2021. Any non-affected product and any product returned after the date specified will not receive replacement. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records. 7. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling 888-3
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
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