FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
- Recall number
- Z-1879-2018
- Recalling firm
- CooperSurgical, Inc.
- Product
- Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
- Status
- Terminated
- Initiated
- 2018-03-12
- Posted
- not on file
- Terminated
- 2019-05-08
- Reason
- Products have been packaged with an incorrect product size.
- Root cause
- Under Investigation by firm
- Action
- On March 26, 2018 CooperSurgical mailed medical device recall notification letters to affected customers. Customers were instructed to: please discontinue use of any of the lots listed in the table above and complete the attached Acknowledgement and Receipt Form to schedule refund or exchange. If you have supplied or transferred any potentially affected product to another facility or organization, please let them know of the recall by providing a copy of this letter. If you have any further questions, please feel free to contact CooperSurgical at recall@coopersurgical.com.
- Quantity
- 500
- Distribution
- CA, SC, WI, MI, NH, MD, OH, NJ, Australia, France, Spain
- Lot, serial or model codes
- Lot number: 212074
- 510(k) numbers
- ["K061651"]
- PMA numbers
- not on file
- Product code
- HGI
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- 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