FDA Medical Device Recalls (openFDA)
Watson Diagnostics Inc.: Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box.
- Recall number
- Z-0977-03
- Recalling firm
- Watson Diagnostics Inc.
- Product
- Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box.
- Status
- Terminated
- Initiated
- 2003-08-07
- Posted
- 2003-08-26
- Terminated
- 2007-12-14
- Reason
- Lights split, spilling contents when bent to activate.
- Root cause
- Other
- Action
- Users are instructed to cease use and return the product immediately in a letter issued 8/7/2003 return receipt requested.
- Quantity
- 662 boxes
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot numbers 24C06B, 24C06D, 24C06E, 24D04S.
- 510(k) numbers
- ["K963391"]
- PMA numbers
- not on file
- Product code
- MPU
- Firm FEI
- 2024830
- Firm city
- Corona
- Firm state
- CA
- 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