FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND PRINEO System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound durinQ application of the liquid adhesive
- Recall number
- Z-1147-2018
- Recalling firm
- Ethicon, Inc.
- Product
- DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND PRINEO System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound durinQ application of the liquid adhesive
- Status
- Terminated
- Initiated
- 2017-11-27
- Posted
- not on file
- Terminated
- 2019-04-30
- Reason
- Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off.
- Root cause
- Component change control
- Action
- Ethicon sent an URGENT MEDICAL DEVICE RECALL REMOVAL letter dated November 2017 to customers titled: "DERMABONDTM PRINEOTM SKIN CLOSURE SYSTEM (22 CM)". The letter identified the affected product, problem and action to be taken. The letter instructed customers to do not use or distribute any product which is subject to recall. Customers are asked to examine inventory, quarantine products that are subject to recall and contact the firm for return of product. Also, post the recall letter in a visible location at facility. If you have additional questions regarding this recall (removal) or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET.
- Quantity
- 20,090 eaches (10,545 units)
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- LEJ230 LEJ246 LEJ259 LEJ368 LGP375 LGP605 LGP606 LGP675 LGP814 LGR689 LGR710 LGR756 LHH468 LHH469 LHH560 LHH608 LHH686 LHH784 LHP498 LHP599 LHP602 LHP868
- 510(k) numbers
- ["K133864"]
- PMA numbers
- not on file
- Product code
- OMO
- Firm FEI
- 2210968
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28