The IFU for the Autoclavable Temperature Probes: Part # 453564635891 — Class II medical device recall Z-0926-2022
Ongoing recall by Philips North America, LLC, reported 2022-04-20, distributed nationwide. Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
| Recall number | Z-0926-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2022-02-07 |
| Classified | 2022-04-13 |
| Reported by FDA | 2022-04-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, AW, BB, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, JO, JP, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PY, QA, RO, RS, SA, SE, SG, SK, SV, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 478,931 units |
| UPC / GTIN / UDI-DI | 00884838000995, 00884838001008, 00884838001015, 00884838008045, 00884838008052, 00884838008069 |
| Model numbers | 21075A, 21076A, 21078A, 453564635891, 989803162621, 989803162631, 989803162641 |
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 for recall
Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0926-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.