CLASS II Device recall · Reported 17 Oct 2018 · FDA Enforcement Report
Insorb Subcuticular Skin Stapler recalled by Incisive Surgical
Incisive Surgical is recalling Insorb Subcuticular Skin Stapler. The recall was initiated on 29 Aug 2018 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-0078-2019
- FDA event ID
- 81008
- Recalling firm
- Incisive Surgical, Plymouth, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Aug 2018
- FDA classified
- 5 Oct 2018
- Reported
- 17 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 29 Aug 2018 | Recall initiated by company | |
| 5 Oct 2018 | Classified by FDA | +37 days |
| 17 Oct 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possible compromise of the sterile barrier integrity
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
Where it was distributed
Israel
Questions about this recall
Is Insorb Subcuticular Skin Stapler recalled?
Yes. Incisive Surgical recalled Insorb Subcuticular Skin Stapler on 29 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-0078-2019.
Why was it recalled?
Possible compromise of the sterile barrier integrity
Which lots are affected?
UDI 10867516000101 Lot Number 182801
Where was it sold?
Israel
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.
More recalls from Incisive Surgical
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Insorb Subcuticular Skin Stapler recalled by Incisive Surgical | Incisive Surgical | Other | Nationwide |
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| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |