Medical Indicators Recalls Tempa DOT Single-Use Clinical Thermometers
Medical Indicators, Inc. is recalling Tempa DOT single-use clinical thermometers due to potential mislabeling. The recall affects 111,800 boxes distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to mislabeling, which fits the rubric for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Medical Indicators, Inc. is recalling Tempa DOT Single-Use Clinical Thermometers because the products may have been mislabeled. The recalled items are individually wrapped, single-use, disposable clinical thermometers intended for oral or axillary use.
The recall involves 111,800 boxes (5,590 full boxes) of the product. The affected lots are 06068, 06083, 06112, 06126, 06129, 06138, 06153, 06219, and 06225. These thermometers were distributed nationwide in the United States, including in California, Georgia, Florida, Indiana, New York, Nevada, Ohio, Pennsylvania, Tennessee, Texas, Virginia, and Wisconsin.
Consumers and healthcare providers should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to the supplier or disposed of according to local regulations. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- 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…
- Manufacturer
- Medical Indicators, Inc.
- Category
- Medical Device — Thermometers
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lots 06068
- 06083
- 06112
- 06126
- 06129
- 06138
- 06153
- 06219
- and 06225
Distribution
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