FDAClass IISeptember 11, 2019

Norm-O-Temp recall

Norm-O-Temp model 111W

Why was Norm-O-Temp recalled?

The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial number Range: 091-N6669-192-N7901 UDI: 10613031861563, 10613031861570, 10613031861587, 10613031861617 Part # 86156, 86157,86158, 86161

Product
Norm-O-Temp model 111W
Recalling firm
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Quantity
1063
Distribution
Ship-To State AL AR AZ CA CO CT DC DE FL GA HI IL IN KS KY LA MA MD ME MI MN MO NC ND NE NH NJ NM NY OH OK PA RI SC TN TW TX UT VA WA WI WV WY Ship-To Country United States Taiwan Egypt United Arab Emirates Israel Pakistan Turkey Colombia Thailand Kuwait United Kingdom Mexico Netherlands Canada Ecuador South Korea Germany Georgia China Panama Japan Malaysia Hong Kong Austria Chile Mongolia Morocco Australia Indonesia Venezuela Singapore
Recall date
September 11, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls