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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 2621–2640 of 39,430 recalls

Class IIOngoing

Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.

Philips North America Llc

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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 IIOngoing

Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317

Philips North America Llc

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

August 13, 2025 · DeviceView details →
Class IIOngoing

UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520

Beckman Coulter Inc.

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

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 IIOngoing

UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858

Beckman Coulter Inc.

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

August 13, 2025 · DeviceView details →
Class IIOngoing

Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.

Philips North America Llc

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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 IIOngoing

Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.

Philips North America Llc

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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 IIOngoing

Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.

Philips North America Llc

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

August 13, 2025 · DeviceView details →
Class IOngoing

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Max Mobility LLC

Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.

August 12, 2025 · DeviceView details →
Class IOngoing

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Max Mobility LLC

Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.

August 12, 2025 · DeviceView details →
Class IIOngoing

Artis Pheno. Image-Intensified Flouroscopic X-Ray System.

Siemens Medical Solutions USA, Inc

Limited system movements after startup .

August 12, 2025 · DeviceView details →
Class IICompleted

NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.

Applied Medical Technology Inc

The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.

August 12, 2025 · DeviceView details →
Class IOngoing

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Max Mobility LLC

Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.

August 12, 2025 · DeviceView details →
Class IICompleted

NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.

Applied Medical Technology Inc

The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.

August 12, 2025 · DeviceView details →
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