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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94825

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

Open FDA event record

Event summary

Timeline bucket
June 13, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Baxter Healthcare Corporation

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

Braun Thermoscan¿ PRO 6000 Ear Thermometer

Z-2339-2024
Recall number
Z-2339-2024
Initiated
June 13, 2024
Classification
Class II
Status
Ongoing
Quantity
265,647 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).

Code information

UDI: 00732094309003 (product code 06000-200) and 00732094309027 (product code 06000-300); All serial numbers.

Distribution pattern

Distributed to United States, Canada, Australia, Malaysia, New Zealand, Philippines, Austria, Belgium, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, and United Kingdom. UPDATED PER EMAIL DATED 7/24/2024: United States (including Puerto Rico and Guam), Canada, Australia, Brunei, Hong Kong, India, Korea, Malaysia, Maldives, Myanmar, New Zealand, Philippines, Singapore, Taiwan, Thailand, Vietnam, Afghanistan, Austria, Bahrain, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Luxemburg, Namibia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Yemen, Bahamas, Bolivia, Chile, Colombia, Ecuador, Guatemala, Mexico, and Panama.