Recall archive / FDA device enforcement
The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following pr... — FDA record Z-0926-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 7, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641.
- Reason
- Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
- Classification
- Class II
- Recalling firm
- Philips North America, LLC
- Quantity
- 478,931 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0926-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All lots manufactured IFUs from 2008 to present. UDI for probe model 21075A (01)00884838000995, model 21076A (01)00884838001008, model 21078A (01)00884838001015, model 989803162621 (01)00884838008045, model 989803162631 (01)00884838008052, and model 989803162641 (01) 00884838008069 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution: US (nationwide) Including Puerto Rico and OUS (foreign) countries including: Afghanistan, Albania, Algeria, Angola, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Burundi, Cambodia, Canada, Chile, China, Columbia, Congo (Democratic Republic of the), Costa Rica, Cote D'lvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Japan, Jordan, Kazakhstan, Korea Republic of, Kuwait, Lao People's Democratic Republic, Latvia, Lebanon, Liberia, Libya, Lithuania, Luxembourg, Macao, Macedonia, Malaysia, Maldives, Mali, Malta, Mauritius, Mayotte, Mexico, Moldova, Mongolia, Montenegro, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, Netherlands Antilles, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saint Lucia, Saint Pierre and Miquelon, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Suriname, Swaziland, Sweden, Switzerland, Syrian and Republic, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen and Zambia.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 20, 2022
- Recall initiation date
- Feb 7, 2022
- Center classification date
- Apr 13, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.