CLASS II Device recall · Reported 23 Aug 2017 · FDA Enforcement Report

ThermaSure(TM), a Cenorin(TM) product recalled

Cenorin is recalling ThermaSure(TM), a Cenorin(TM) product, Series 130 Medical Device Dryer: (a), distributed nationwide in the US. The recall was initiated on 7 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(a) Serial Numbers: 350423, 350424, 351506, 351507, 351512, 351513, 351514, 351516, 351602, 351604, 351605, 351606, 351609, 351611, 351613, 351614, 351615, 351616, 351617, 351618, 351619, 351620, 351621, 351622, 351623, 351624 (b) Serial numbers: 361505, 361511, 361515, 361601, 361603, 361607, 361608, 361612

Quantity recalled34 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3032-2017
FDA event ID: 77637
Recalling firm: Cenorin, Kent, WA
Classification: Class II
Status: Terminated
Recall initiated: 7 Jun 2017
FDA classified: 14 Aug 2017
Reported: 23 Aug 2017
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

7 Jun 2017	Recall initiated by company
14 Aug 2017	Classified by FDA	+68 days
23 Aug 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.

Product as listed by the FDA

ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices

Where it was distributed

Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel

Nationwide

Questions about this recall

Why was it recalled?

Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.

Which lots are affected?

(a) Serial Numbers: 350423, 350424, 351506, 351507, 351512, 351513, 351514, 351516, 351602, 351604, 351605, 351606, 351609, 351611, 351613, 351614, 351615, 351616, 351617, 351618, 351619, 351620, 351621, 351622, 351623, 351624 (b) Serial numbers: 361505, 361511, 361515, 361601, 361603, 361607, 361608, 361612

Where was it sold?

Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 77637

This product is part of a recall event; the main page for the event is ThermaSure(TM), a Cenorin(TM) product recalled.

Reported	Class	Recall	Company	Reason	Where
23 Aug 2017	CLASS II	ThermaSure(TM), a Cenorin(TM) product recalled	Cenorin	Other	Nationwide
23 Aug 2017	CLASS II	ThermaSure(TM), a Cenorin(TM) product recalled	Cenorin	Other	Nationwide

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All 6

Reported	Class	Recall	Company	Reason	Where
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23 Aug 2017Device	CLASS II	ThermaSure(TM), a Cenorin(TM) product recalled	Cenorin	Other	Nationwide
16 Jul 2014Device	CLASS II	HLD System recalled by Cenorin	Cenorin	Temperature Abuse	Nationwide
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