Z-0926-2022Class II

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

Name: Z-0926-2022 The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the...
Creator: Philips North America, LLC
Published: 2022-02-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2022-02-07 / Open, Classified / root cause: design

FDA source

Philips North America, LLC began a recall of The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A... on 2022-02-07. FDA classified it as Class II and gives the reason as "Update to instructions for use regarding the cleaning and disinfection process for the reusable probes". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0926-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-07
Posted: 2022-04-13
Recalling firm: Philips North America LLC
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.
Product code: FFL Dislodger, Stone, Basket, Ureteral, Metal
Reason for recall: Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Philips, issued "URGENT Medical Device Recall" Customer notification letters on 07 Feb 2022 via certified mail. Actions planned by the firm: An IFU addendum (part# 453564978601) was created that provides updated instructions for cleaning, disinfection, and sterilization. This addendum is to be downloaded www.philips.com/ifu and kept with the main IFU (part# 453564635891). Customer should take the following actions to prevent risk to patients or users: Prepare and soak in an enzymatic solution (detergent) to remove any debris prior to disinfection or sterilization. To reduce risk of cross-infection always clean all probes before applying to a different patient. Esophageal/Rectal Probes must be cleaned and sterilized between patient use. Skin probes can be cleaned and disinfected or cleaned and sterilized between patient use. Contact Philips Customer Services with questions. US customers: 1 (800) 722-9377, Worldwide customers: Contact local Philips representative.
Quantity in commerce: 478,931 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0926-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0926-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-13

Product code FFL

K962070Class IIYsi 400 Series Atuoclavable Reusable Temperature ProbeYellow Springs Instrument Co., Inc. / cleared 1996-07-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)