FDA Medical Device Recalls (openFDA)
Cincinnati Sub-Zero Products: Warm Air Model 135 Warming Units.
- Recall number
- Z-0374-05
- Recalling firm
- Cincinnati Sub-Zero Products
- Product
- Warm Air Model 135 Warming Units.
- Status
- Terminated
- Initiated
- 2004-11-05
- Posted
- 2004-12-30
- Terminated
- 2008-10-29
- Reason
- Burning smell, burned microprocessor board. The firm is modifying the connectors and wiring gauge configuration of the device.
- Root cause
- Other
- Action
- The firm notified consignees by certified letter on November 5, 2004.
- Quantity
- 649 units.
- Distribution
- The product was distributed throughout the United States and to foreign countries including Saudi Arabia, Taiwan, Japan, and Canada.
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- ["K942599"]
- PMA numbers
- not on file
- Product code
- BTE
- Firm FEI
- 1516825
- 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