FDA Medical Device Recalls (openFDA)
Incisive Surgical Inc: INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
- Recall number
- Z-0078-2019
- Recalling firm
- Incisive Surgical Inc
- Product
- INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
- Status
- Terminated
- Initiated
- 2018-08-29
- Posted
- not on file
- Terminated
- 2019-03-18
- Reason
- Possible compromise of the sterile barrier integrity
- Root cause
- Process control
- Action
- The firm initiated the recall by telephone and email on 08/209/2018. The email notice requested that immediate suspension of all distribution. The firm will arrange to recover the product.
- Quantity
- 1200 units
- Distribution
- Israel
- Lot, serial or model codes
- UDI 10867516000101 Lot Number 182801
- 510(k) numbers
- ["K120373"]
- PMA numbers
- not on file
- Product code
- GDW
- Firm FEI
- 3004028675
- Firm city
- Plymouth
- Firm state
- MN
- 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