FDA Medical Device Recalls (openFDA)
Apple Medical Corporation: Fischer Cone Biopsy Excisor - Medium Model: 900-151
- Recall number
- Z-0615-06
- Recalling firm
- Apple Medical Corporation
- Product
- Fischer Cone Biopsy Excisor - Medium Model: 900-151
- Status
- Terminated
- Initiated
- 2006-03-10
- Posted
- 2006-04-06
- Terminated
- 2016-03-07
- Reason
- Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
- Root cause
- Other
- Action
- Apple Medical Corporation issued letters dated March 21, 2006 to direct accounts and distributors via US Mail. Distributors are requested to sub-recall. Product is to be returned to the firm and destroyed.
- Quantity
- 2,813.0 boxes
- Distribution
- Nationwide Foreign: Australia, Austria, Taiwan, England, FInland, Germany, Iceland, Israel, Italy, Portugal, Hong Kong, Spain, The Netherlands, Chile.
- Lot, serial or model codes
- Lot Numbers: D201704, A2002, D201705, D201703, D205001 D209315, D211317, D218412, D217007, D220314, D224801, D224801, D232202 D301327, D302105, D304805, C143E, C213G, D307906, D093H, D311206, D313506 E193A, D316304, D318111, H213A, I153B I153, J073A, J283A, K063M, L043A, L153O A024, A134E
- 510(k) numbers
- ["K961460"]
- PMA numbers
- not on file
- Product code
- HGI
- Firm FEI
- 1216677
- Firm city
- Marlborough
- 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