FDA Medical Device Recalls (openFDA)
Remel Inc.: SWIN 2017 database, Model YSW4000
- Recall number
- Z-1939-2020
- Recalling firm
- Remel Inc.
- Product
- SWIN 2017 database, Model YSW4000
- Status
- Terminated
- Initiated
- 2019-01-04
- Posted
- not on file
- Terminated
- 2020-08-17
- Reason
- Potential for out of range microbial results
- Root cause
- Software design
- Action
- Technicians replaced YSW514-17 with YSW514-17A.
- Quantity
- 250
- Distribution
- ...
- Lot, serial or model codes
- ...
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LON
- Firm FEI
- 1000515493
- Firm city
- Oakwood Village
- 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