FDA Medical Device Recalls (openFDA)
Cenorin, LLC: ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices
- Recall number
- Z-3034-2017
- Recalling firm
- Cenorin, LLC
- Product
- ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices
- Status
- Terminated
- Initiated
- 2017-06-07
- Posted
- not on file
- Terminated
- 2018-05-02
- Reason
- Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
- Root cause
- Process control
- Action
- Cenorin initially contacted all domestic customers at the facility and distributor level via phone on June 7, 2017, which was followed by an Urgent Medical Device Recall letter dated July 20, 2017, to all affected customers. Cenorin sent initial notification to international distributors via email. Customers were asked to immediately examine their inventory for the affected product. If the product exhibits any symptoms of failure, immediately cease using it and contact Cenorin immediately at recall@cenorin.com or call Technical Support at 800-426-1042, ext 224.
- Quantity
- 18 units
- Distribution
- Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel
- Lot, serial or model codes
- (a) Serial Numbers: 191601, 191602, 191604, 191605, 19161, 191611, 191612, 191613, 191614, 191615, 191616 (b) Serial numbers: 101505, 101506, 101603, 101606, 101607, 101608, 101609
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JRJ
- Firm FEI
- 3004153171
- Firm city
- Kent
- Firm state
- WA
- 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