FDA Device recall Z-0926-2022
The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A…
- FDA Device
- Class II
- ongoing
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class II recall of The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A… by Philips North America, citing update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0926-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-07 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
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.
Identifiers
| code_info | All lots manufactured IFUs from 2008 to present. UDI for probe model 21075A (01)00884838000995, model 21076A (01)00884…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0926-2022%22
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