FDA Medical devices recall ·
S4-1 Transducer Probe recall
- Recall number
- Z-2391-2025
- Date
- (initiated July 3, 2025)
- Company / brand
- Philips Ultrasound, Inc
1 Echo Dr, Reedsville, PA, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 171,322 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
S4-1 Transducer Probe
Why was it recalled?
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. 989605389271, 989605389272, 989605364993; UDI: (01)00884838061415(21)B30VBN, (01)00884838061415(21)F0954W, (01)00884838061415(21)B3WCRT, (01)00884838061415(21)B1WDKX, (01)00884838061415(21)B1WDNQ, (01)00884838064584(21)B13HXX, (01)00884838064584(21)B1MQDX, (01)00884838064584(21)B23LRM, (01)00884838064584(21)B23LRT, (01)00884838061415(21)B1X9Z3, (01)00884838064584(21)B12QQ8, (01)00884838061415(21)B27XB2, (01)00884838061415(21)B307TT, 010088483806141521F01WFB, (01)00884838061415(21)B30THD, (01)00884838061415(21)B1TKB3, (01)00884838061415(21)F08XDL, (01)00884838061415(21)F0B7L5, (01)00884838061415(21)F048QQ, (01)00884838061415(21)F0665R; Serial No. B30VBN, B1GPT4, B1NW75, F0954W, B3WCRT, B1WDKX, B1WDNQ, B13HXX, B1MQDX, B23LRM, B23LRT, B1X9Z3, B12QQ8, B27XB2, B307TT, F01WFB, B1KXRP, B30THD, B1TKB3, F08XDL, F0B7L5, F048QQ, F0665R.
Distribution
US Nationwide distribution.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-2391-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.