Reported Apr 20, 2022 · Ongoing

The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following…

Philips North America, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • The IFU
  • for the Autoclavable Temperature ProbesPart # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641
Lot codes and dates

6 of 6 products

Products covered by this recall
Model / numberBarcodesProduct as published
21075A00884838000995(01)00884838000995
21076A00884838001008(01)00884838001008
21078A00884838001015(01)00884838001015
98980316262100884838008045(01)00884838008045
98980316263100884838008052(01)00884838008052, and
98980316264100884838008069(01) 00884838008069
Amount recalled
478,931 units

Where it was sold

Why it was recalled

Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:43 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.