FDA Medical Device Recalls (openFDA)
Ethicon Endo-Surgery: Mammotome EX Holster
- Recall number
- Z-0440-05
- Recalling firm
- Ethicon Endo-Surgery
- Product
- Mammotome EX Holster
- Status
- Terminated
- Initiated
- 2004-12-10
- Posted
- 2005-01-27
- Terminated
- 2008-10-29
- Reason
- A capacitor of the wrong value was used. The capacitor used was 0.11 microfarad instead of 0.22 microfarad called for in the product specifications.
- Root cause
- Other
- Action
- The recalling firm notified hospitals and distributors of the product by letter, dated 12/10/04.
- Quantity
- 120 devices
- Distribution
- The product was distributed to consignees located in MI, TN, IL, NC, GA, IL, CA, FL, IN, WI, TX, AR, KS, IA, OK, NY, PA, MS, KY, ME, MO, MA, VA, NJ, LA, MN, SD, UT, CO, AL, and NH. There are no foreign consignees.
- Lot, serial or model codes
- HRDE39904, HRDE40502, HRDE40102, HRDE39920 HRDE40209, HRDE40204, HRDE39916, HRDE40220 HRDE39921, HRDE40114, HRDE40225, HRDE40508 HRDE40210, HRDE40222, HRDE39919, HRDE39906 HRDE40218, HRDE40724, HRDE40109, HRDE39903 HRDE40106, HRDE40118, HRDE40203, HRDE40113 HRDE40511, HRDE40206, HRDE39908, HRDE39910 HRDE40701, HRDE40513, HRDE40713, HRDE40720 HRDE40718, HRDE40710, HRDE40704, HRDE40716 HRDE40706, HRDE40520, HRDE40722, HRDE40708 HRDE40714 HRDE40522, HRDE40719, HRDE40705 HRDE40525, HRDE40527, HRDE40721, HRDE40703 HRDE40516, HRDE40725, HRDE40709, HRDE40702 HRDE40715, HRDE40518, HRDE40506, HRDE40519 HRDE40707, HRDE40712, HRDE40711, HRDE39922 HRDE40103, HRDE39901, HRDE40126, HRDE40120 HRDE39905, HRDE40723, HRDE40101, HRDE40205 HRDE40214, HRDE40526, HRDE40618, HRDE39902 HRDE40202, HRDE40122, HRDE40217, HRDE40221 HRDE40216, HRDE40624, HRDE39924, HRDE40717 HRDE40226, HRDE40503, HRDE40213, HRDE40107 HRDE40110, HRDE40524, HRDE40121, HRDE40514 HRDE39925, HRDE39909, HRDE39912, HRDE40505 HRDE40112, HRDE40212, HRDE40510, HRDE40208 HRDE40201, HRDE39907, HRDE39926, HRDE40124 HRDE40223, HRDE39923, HRDE40219, HRDE40111 HRDE40509, HRDE40515, HRDE40517, HRDE40108 HRDE39918, HRDE40521, HRDE40123, HRDE39914 HRDE39915, HRDE40501, HRDE40211 HRDE40224 HRDE40105, HRDE40207, HRDE39911, HRDE39911, HRDE 39913
- 510(k) numbers
- ["K033700"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 1527736
- Firm city
- Cincinnati
- Firm state
- OH
- 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