Z-0953-2021Class II

Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated...

Name: Z-0953-2021 Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated...
Creator: Ethicon, Inc.
Published: 2021-01-04
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2021-01-04 / Terminated / root cause: packaging

FDA source

Ethicon, Inc. began a recall of Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions... on 2021-01-04. FDA classified it as Class II and gives the reason as "Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0953-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-04
Posted: 2021-02-04
Terminated: 2023-11-29
Recalling firm: Ethicon, Inc
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
Product code: MPN Tissue Adhesive For The Topical Approximation Of Skin
Reason for recall: Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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 [email protected] 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-
Quantity in commerce: 23,580 eaches
Distribution: US Nationwide
Product codes and lots: Lot Number: QEBBTQ Exp. Date: April 30, 2022 GTIN: 10705031203532

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0953-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0953-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-10	2021-02-04

Product code MPN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)