Exact FDA event identifier

Event 65905

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: July 10, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Medical Indicators, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2162-2013

Recall number: Z-2162-2013
Initiated: July 10, 2013
Classification: Class II
Status: Terminated
Recalling firm: Medical Indicators, Inc.
Quantity: 111,800 boxes (5,590 full boxes)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

TempaDot products may have been mislabeled.

Code information

Lots 06068, 06083, 06112, 06126, 06129, 06138, 06153, 06219, and 06225

Distribution pattern

Nationwide distribution: USA including states of: CA, GA, FL, IN, NY, NV OH, PA, TN,TX, VA, and WI.