CLASS II Device recall · Reported 28 Mar 2018 · FDA Enforcement Report
Dermabond" Prineo" Skin Closure System recalled by Ethicon
Ethicon is recalling Dermabond" Prineo" Skin Closure System, distributed nationwide in the US. The recall was initiated on 27 Nov 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1147-2018
- FDA event ID
- 79355
- Recalling firm
- Ethicon, Somerville, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Nov 2017
- FDA classified
- 20 Mar 2018
- Reported
- 28 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 27 Nov 2017 | Recall initiated by company | |
| 20 Mar 2018 | Classified by FDA | +113 days |
| 28 Mar 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Dermabond" Prineo" Skin Closure System recalled?
Yes. Ethicon recalled Dermabond" Prineo" Skin Closure System on 27 Nov 2017. The recall is Class II and its status is Terminated. Recall number Z-1147-2018.
Why was it recalled?
Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off.
Which lots are affected?
LEJ230 LEJ246 LEJ259 LEJ368 LGP375 LGP605 LGP606 LGP675 LGP814 LGR689 LGR710 LGR756 LHH468 LHH469 LHH560 LHH608 LHH686 LHH784 LHP498 LHP599 LHP602 LHP868
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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