FDA Medical Device Recalls (openFDA)
Medical Indicators, Inc.: 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.
- Recall number
- Z-2162-2013
- Recalling firm
- Medical Indicators, Inc.
- 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 Medical Indicators from 3M) and labeling in 806, TempaDOT thermometers are individually wrapped, single-use, disposable clinical thermometers for oral or axillary use.
- Status
- Terminated
- Initiated
- 2013-07-10
- Posted
- 2013-09-06
- Terminated
- 2014-01-16
- Reason
- TempaDot products may have been mislabeled.
- Root cause
- Labeling mix-ups
- Action
- The firm, Medical Indicators Inc.sent an "URGENT" Recall letter dated July 10, 2013 and Acknowledgement Form to all distributors/customers via email and Priority Mail with delivery confirmation. The letter described the product, problem and actions to be taken. The customers were instructed to check full & partial cases of the tempadot; open and inspect all 5122NS cases; pull out and quarantine any of the lots found in the 5122NS cases, pending return to medical indicators; if individual Tempadot 100-count boxes of 5122 and 5122NS are stored in different warehouse follow the instructions provided in the letter; if Tempadot 100-count boxes of 5122 were sold to a customer with the affected lots, contact the customer and have them return the product; and complete and return the Recall Return Response Acknowledgement and Receipt Form via mail to: 16 Thomas J Rhodes Industrial Drive, Hamilton NJ, 08619; fax: (609) 587-5636 or email to: www.medicalindicators.com or General Manager at: pbaker@medicalindicators.com. Contact information for any question(s) related to this recall may be addressed to General Manager of Medical Indicators, Inc. at 609-737-1600, extension 204 or email to: pbaker@medicalindicators.com, Mondays through Fridays from 8:00am to 5:00pm EST.
- Quantity
- 111,800 boxes (5,590 full boxes)
- Distribution
- Nationwide distribution: USA including states of: CA, GA, FL, IN, NY, NV OH, PA, TN,TX, VA, and WI.
- Lot, serial or model codes
- Lots 06068, 06083, 06112, 06126, 06129, 06138, 06153, 06219, and 06225
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FQZ
- Firm FEI
- 2246308
- Firm city
- Hamilton
- Firm state
- NJ
- 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