CLASS II Device recall · Reported 18 Sep 2013 · FDA Enforcement Report
Tempa DOT Single-Use Clinical Thermometer Medical Indicators recalled
Medical Indicators is recalling Tempa DOT Single-Use Clinical Thermometer Medical Indicators, distributed nationwide in the US. The recall was initiated on 10 Jul 2013 and the FDA has classified it as Class II.
Check your package
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-2162-2013
- FDA event ID
- 65905
- Recalling firm
- Medical Indicators, Hamilton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jul 2013
- FDA classified
- 6 Sep 2013
- Reported
- 18 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Patient Monitors
Timeline
| 10 Jul 2013 | Recall initiated by company | |
| 6 Sep 2013 | Classified by FDA | +58 days |
| 18 Sep 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
TempaDot products may have been mislabeled.
Product as listed by the FDA
Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by Medical Indicators from 3M) and labeling in 806, TempaDOT thermometers are individually wrapped, single-use, disposable clinical thermometers for oral or axillary use.
Where it was distributed
Nationwide distribution: USA including states of: CA, GA, FL, IN, NY, NV OH, PA, TN,TX, VA, and WI.
Nationwide CaliforniaFloridaGeorgiaIndianaNevadaNew YorkPennsylvaniaTennesseeTexasVirginiaWisconsin
Stores named: Online Retailers
Questions about this recall
Is Tempa DOT Single-Use Clinical Thermometer Medical Indicators recalled?
Yes. Medical Indicators recalled Tempa DOT Single-Use Clinical Thermometer Medical Indicators on 10 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-2162-2013.
Why was it recalled?
TempaDot products may have been mislabeled.
Which lots are affected?
Lots 06068, 06083, 06112, 06126, 06129, 06138, 06153, 06219, and 06225
Where was it sold?
Nationwide distribution: USA including states of: CA, GA, FL, IN, NY, NV OH, PA, TN,TX, VA, and WI.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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