FDA Medical Device Recalls (openFDA)
Natus Manufacturing Limited: Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items
- Recall number
- Z-0951-2017
- Recalling firm
- Natus Manufacturing Limited
- Product
- Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items
- Status
- Terminated
- Initiated
- 2016-10-15
- Posted
- not on file
- Terminated
- 2019-06-24
- Reason
- The fuse blows during initial power up or after a period of time. This results in a complete loss of power to the Cabinet and in some cases has resulted in the fuse cover for the power inlet melting slightly.
- Root cause
- Mixed-up of materials/components
- Action
- Natus Manufacturing Limited sent an "Urgent Field Safety Notice" letter dated April, 2016, via email. The letter described the problem and the product involved in the recall. Informed the consignees that a repair kit to correct the issue is available for repair of affected units. Requested consignees to complete the attached form and Faxto 847-949-6031 or e-mail it to Natus Quality Programs. In turn the firm will send the repair kit. For questions contact Technical Service at 888-496-2887. For questions regarding this recall call 888-496-2887.
- Quantity
- 31
- Distribution
- Worldwide Distribution - US including NJ, NC, TX, IL, VA, NY, FL, CA, MS, WA, IN, and MA. and Internationally to Canada and Costa Rica.
- Lot, serial or model codes
- Warmette Blanket Cabinet Serial Numbers: 10216709, 10216711, 10218559, 10219214, 10219337, 10219338, 10219339, 10219340, 10219387, 10219388, 10219869, 10219870, 10219871, 10219872, 10219873, 1028880. Warmette Dual Cabinet Serial Numbers: 10216713, 10216714, 10218500, 10218501, 10218522, 10218526, 10218528, 10218982, 10219257, 10219389, 10219390, 10220534, 10220536, 10220537, 10220538.
- 510(k) numbers
- ["K132110"]
- PMA numbers
- not on file
- Product code
- LGZ
- Firm FEI
- 3005581270
- Firm city
- GORT Galway
- Firm state
- not on file
- Firm country
- Ireland
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
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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