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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 21–37 of 37 recalls

Class IIIOngoing

Philips Mini Multi TEE Ultrasound Transducer

Philips Ultrasound, Inc

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

September 5, 2025 · DeviceView details →
Class IIIOngoing

Philips OMNI III TEE Ultrasound Transducer

Philips Ultrasound, Inc

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

September 5, 2025 · DeviceView details →
Class III
Ongoing

Philips 3D6-2 Ultrasound Transducer

Philips Ultrasound, Inc

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

September 5, 2025 · DeviceView details →
Class IIIOngoing

Philips X7-2 Ultrasound Transducer

Philips Ultrasound, Inc

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

September 5, 2025 · DeviceView details →
Class IIIOngoing

Philips C9-4 Ultrasound Transducer

Philips Ultrasound, Inc

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

September 5, 2025 · DeviceView details →
Class IIIOngoing

Philips L12-5 Ultrasound Transducer

Philips Ultrasound, Inc

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

September 5, 2025 · DeviceView details →
Class IIIOngoing

Penner Pacific Bathing Spa, Model Numbers 360020-1P

Penner Patient Care, Inc.

The device does not bear a unique device identifier.

August 13, 2025 · DeviceView details →
Class IIIOngoing

Penner Pacific Bathing Spa, Model Numbers 360020-1EP

Penner Patient Care, Inc.

The device does not bear a unique device identifier.

August 13, 2025 · DeviceView details →
Class IIIOngoing

Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT

Penner Patient Care, Inc.

The device does not bear a unique device identifier.

August 13, 2025 · DeviceView details →
Class IIIOngoing

Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1

Penner Patient Care, Inc.

The device does not bear a unique device identifier.

August 13, 2025 · DeviceView details →
Class IIIOngoing

Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB

Penner Patient Care, Inc.

The device does not bear a unique device identifier.

August 13, 2025 · DeviceView details →
Class IIIOngoing

Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X

Penner Patient Care, Inc.

The device does not bear a unique device identifier.

August 13, 2025 · DeviceView details →
Class IIIOngoing

Penner Pacific Bathing Spa, Model Numbers 860010-1L

Penner Patient Care, Inc.

The device does not bear a unique device identifier.

August 13, 2025 · DeviceView details →
Class IIIOngoing

Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL

Penner Patient Care, Inc.

The device does not bear a unique device identifier.

August 13, 2025 · DeviceView details →
Class IIIOngoing

Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X

Penner Patient Care, Inc.

The device does not bear a unique device identifier.

August 13, 2025 · DeviceView details →
Class IIIOngoing

Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2

Penner Patient Care, Inc.

The device does not bear a unique device identifier.

August 13, 2025 · DeviceView details →
Class IIIOngoing

FloPatch FP120, REF: FP120-FOT01-005

Flosonics Medical (R/A 1929803 ONTARIO CORP.)

Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.

August 7, 2025 · DeviceView details →
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