Philips S4-1 Ultrasound Transducer

Class I - Dangerous

🏥 Medical Devices Recalled: September 5, 2025 Philips Ultrasound Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
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, (01)00884838085183(21)B25VWD, (01)00884838085183(21)B2Y9PD, (01)00884838085183(21)B2Y9W3, (01)00884838085183(21)B1RCZK, (01)00884838086579(21)B2C76J, (01)00884838085183(21)B2D30D, (01)00884838085183(21)B2792J, (01)00884838085183(21)B2D36X, (01)00884838085183(21)B278QM, (01)00884838085183(21)B21Y7X, (01)00884838085183(21)B1ZJVN, (01)00884838085183(21)B1RCRC, (01)00884838074231(21)B1RCWC, (01)00884838074231(21)B1RCQL, (01)00884838074231(21)B1RCMH, 010088483808518321B2D2RX, (01)00884838086579(21)B2C768, (01)00884838085183(21)B2D2DX, (01)00884838085183(21)B21Y85, 010088483808518321B279D9, (01)00884838085183(21)B1RCW9, (01)00884838085183(21)B1RCNG, (01)00884838085183(21)B21XRB, (01)00884838085183(21)B1RD54; Serial No. B25VV3, B21XVK, B1ZJVG, B2D31R, B21XXK, B25VX0, B21Y07, B21Y6L, B21XYW, B1RCNL, B21Y64, B21YF6, B2D34Z, B1RCVN, B1W8DH, B21XTP, B21XXQ, B25VWD, B2Y9PD, B2Y9W3, B1RCZK, B2C76J, B2D30D, B2792J, B2D36X, B278QM, B21Y7X, B1ZJVN, B1RCRC, B1RCWC, B1RCQL, B1RCMH, B2D2RX, B2C768, B2D2DX, B21Y85, B279D9, B1RCW9, B1RCNG, B21XRB, B1RD54.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Philips Ultrasound, Inc
Reason for Recall:: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Philips S4-1 Ultrasound Transducer

Product Codes/Lot Numbers:

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, (01)00884838085183(21)B25VWD, (01)00884838085183(21)B2Y9PD, (01)00884838085183(21)B2Y9W3, (01)00884838085183(21)B1RCZK, (01)00884838086579(21)B2C76J, (01)00884838085183(21)B2D30D, (01)00884838085183(21)B2792J, (01)00884838085183(21)B2D36X, (01)00884838085183(21)B278QM, (01)00884838085183(21)B21Y7X, (01)00884838085183(21)B1ZJVN, (01)00884838085183(21)B1RCRC, (01)00884838074231(21)B1RCWC, (01)00884838074231(21)B1RCQL, (01)00884838074231(21)B1RCMH, 010088483808518321B2D2RX, (01)00884838086579(21)B2C768, (01)00884838085183(21)B2D2DX, (01)00884838085183(21)B21Y85, 010088483808518321B279D9, (01)00884838085183(21)B1RCW9, (01)00884838085183(21)B1RCNG, (01)00884838085183(21)B21XRB, (01)00884838085183(21)B1RD54; Serial No. B25VV3, B21XVK, B1ZJVG, B2D31R, B21XXK, B25VX0, B21Y07, B21Y6L, B21XYW, B1RCNL, B21Y64, B21YF6, B2D34Z, B1RCVN, B1W8DH, B21XTP, B21XXQ, B25VWD, B2Y9PD, B2Y9W3, B1RCZK, B2C76J, B2D30D, B2792J, B2D36X, B278QM, B21Y7X, B1ZJVN, B1RCRC, B1RCWC, B1RCQL, B1RCMH, B2D2RX, B2C768, B2D2DX, B21Y85, B279D9, B1RCW9, B1RCNG, B21XRB, B1RD54.