FDA Medical Device Recalls (openFDA)
OMNIlife science Inc.: OMNI K1 Broach Handle, Product Code HS-10054
- Recall number
- Z-0837-2019
- Recalling firm
- OMNIlife science Inc.
- Product
- OMNI K1 Broach Handle, Product Code HS-10054
- Status
- Terminated
- Initiated
- 2018-11-29
- Posted
- not on file
- Terminated
- 2020-04-16
- Reason
- There is a potential for the inner pin of the handle to become loose and fall out.
- Root cause
- Under Investigation by firm
- Action
- Customers were contacted via telephone on 11/29/18. Advisory Notice letters were also distributed to customers on 12/14/18.
- Quantity
- 7
- Distribution
- The products were distributed to the following US states: CA, GA, SC, and UT.
- Lot, serial or model codes
- Lot Number MM0118
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3008342029
- Firm city
- Raynham
- Firm state
- MA
- 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