The Recall Desk
HighFDA (Devices)·Z-1625-2026·Announced 2026-04-01

[pending] Philips S4-1 Ultrasound Transducer

Pending LLM rewrite. Source: FDA_DEVICE Z-1625-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

The recalled product

Product
Philips S4-1 Ultrasound Transducer
Manufacturer
Philips Ultrasound, Inc
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model No. 989605458221
  • 989605458222
  • 989605477101
  • UDI: (01)00884838085183(21)B25VV3
  • (01)00884838085183(21)B21XVK
  • (01)00884838085183(21)B1ZJVG
  • (01)00884838085183(21)B2D31R
  • (01)00884838085183(21)B21XXK
  • (01)00884838085183(21)B25VX0
  • (01)00884838085183(21)B21Y07
  • (01)00884838085183(21)B21Y6L
  • (01)00884838085183(21)B21XYW
  • (01)00884838085183(21)B1RCNL
  • (01)00884838074231(21)B21Y64
  • (01)00884838074231(21)B21YF6
  • (01)00884838085183(21)B2D34Z
  • (01)00884838085183(21)B1RCVN
  • (01)00884838085183(21)B1W8DH
  • (01)00884838085183(21)B21XTP
  • (01)00884838085183(21)B21XXQ

Distribution

Distributed nationwide across the United States.

Related recalls

Same category