Ethicon, Inc. Us Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12
Brand
Ethicon, Inc. Us
Lot Codes / Batch Numbers
Lot Number: QEBBTQ Exp. Date: April 30, 2022 GTIN: 10705031203532
Products Sold
Lot Number: QEBBTQ Exp. Date: April 30, 2022 GTIN: 10705031203532
Ethicon, Inc. Us is recalling Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approxi due to Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
Recommended Action
Per FDA guidance
Ethicon issued Urgent Medical Device Removal Letter on 1/4/21 via UPS second day. Receipt of the letter will be confirmed via UPS tracking. Letter states reason for recall, health risk, 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 866-853-2807 or Ethicon5582@stericycle.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 5. 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. 6. Customers are required to return unused impacted Dermabond Advanced" Topical Skin Adhesive 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 April 9, 2021. Any non-affected product and any product returned after the date specified will not receive replacement. 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 800-
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026