FDA Device recall Z-2386-2025
mL26-8 Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of mL26-8 Transducer Probe by Philips Ultrasound, citing to provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2386-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-07-03 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
mL26-8 Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989606722361; UDI: (01)00884838108592(21)F08WYR, 010088483810859221F0GDHW, 010088483810859221F0GDJ0, (01)0088…Model No. 989606722361; UDI: (01)00884838108592(21)F08WYR, 010088483810859221F0GDHW, 010088483810859221F0GDJ0, (01)00884838108592(21)F0LCBL, (01)00884838108592(21)F0JX0Q, (01)00884838108592(21)F0GT0X, (01)00884838108592(21)F0KVCN, (01)00884838108592(21)F0LC9H, (01)00884838108592(21)F0H4DG, (01)00884838108592(21)F0J4J8, (01)00884838108592(21)F0HX31, (01)00884838108592(21)F0LQC4, (01)00884838108592(21)F0LQBV, (01)00884838108592(21)F0JX1C, (01)00884838108592(21)F0LC9M, (01)00884838108592(21)F0LC9X, (01)00884838108592(21)F0DM3Y, (01)00884838108592(21)F0KC82, (01)00884838108592(21)F0J4J6, (01)00884838108592(21)F0JZ0P, (01)00884838108592(21)F0D1BV, (01)00884838108592(21)F0H2LF, (01)00884838108592(21)F0H2L7, (01)00884838108592(21)F0HGKW, (01)00884838108592(21)F0LGP6, (01)00884838108592(21)F0C91D, (01)00884838108592(21)F0JQV1, (01)00884838108592(21)F0JR9G, (01)00884838108592(21)F0KGDW, (01)00884838108592(21)F0H9FK, (01)00884838108592(21)F0H9G5, (01)00884838108592(21)F0HYV9, (01)00884838108592( |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2386-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.