FDA Medical Device Recalls (openFDA)
Smith And Nephew, Inc. Endoscopy Division: Endocoupler, C-Mount 30 mm Focal Length Catalog Number: 7204823, 7204823S
- Recall number
- Z-0704-04
- Recalling firm
- Smith And Nephew, Inc. Endoscopy Division
- Product
- Endocoupler, C-Mount 30 mm Focal Length Catalog Number: 7204823, 7204823S
- Status
- Terminated
- Initiated
- 2004-02-19
- Posted
- 2004-07-20
- Terminated
- 2006-06-28
- Reason
- Endocouplers assembled with screws that cannot be effectively sterilized
- Root cause
- Other
- Action
- Smith & Nephew notified customers and sales rep. by letter dated 2/19/04. Sales reps will retrieve product and replace effected units in the field.
- Quantity
- 28 units
- Distribution
- AL, AZ, CA, CT, PA, MA, ME, MI, MO, NC, NH, NJ, NY, OH, UT , TN, TX, VT, WA Foreiing:Australia, Canada, China, Brazil, France, Germany, Greece, India, Italy, Japan.Korea, Netherlands, Norway, Portugal, South Africa, Spain, Turkey, UK
- Lot, serial or model codes
- Part No: 7204823 Serial #s: SR 8433 SR 8472 SR 8504 SR 8562 SR 8391 SR 8506 SR 8538 SR 8555 SR 8392 SR 8395 SR 8489 SR 8494 SR 8554 SR 8471 SR 8485 SR 8477 SR 8568 SR 8513 SR 8514 SR 8394 SR 8520 SR 8493 SR 8567 SR 8569 SR 8396 SR 8533 SR 8561 SR 8534 7204823S SR 8623 SR 8422 SR 8563 SR 8590 SR 8577 SR 8591 SR 8628 SR 8495 SR 8576 SR 8627 SR 8426 SR 8490 SR 8499 SR 8587 SR 8573 SR 8428 SR 8574 SR 8578 SR 8580 SR 8589 SR 8565 SR 8566 SR 8498 SR 8564 SR 8620
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FXM
- Firm FEI
- 3003604053
- Firm city
- Andover
- 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