Medical Device Recalls

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7,959 medical device recalls from federal enforcement feeds.

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Showing 2,551–2,600 of 7,959

Medical Device Recall · August 13, 2025
Beckman Coulter Inc.
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Class II
Medical Device Recall · August 13, 2025
Philips North America Llc
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II
Medical Device Recall · August 13, 2025
Philips North America Llc
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.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II
Medical Device Recall · August 13, 2025
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
The device does not bear a unique device identifier.
Class III
Medical Device Recall · August 13, 2025
Philips North America Llc
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II
Medical Device Recall · August 13, 2025
Beta Bionics, Inc.
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.
Class II
Medical Device Recall · August 13, 2025
Philips North America Llc
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II
Medical Device Recall · August 13, 2025
Penner Patient Care, Inc.
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, 36
The device does not bear a unique device identifier.
Class III
Medical Device Recall · August 13, 2025
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Radiology Solutions software version 14.2.2
Due to software issue, radiology reports may not be fully displayed when viewing.
Class II
Medical Device Recall · August 13, 2025
Philips North America Llc
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II
Medical Device Recall · August 13, 2025
Philips North America Llc
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II
Medical Device Recall · August 13, 2025
Philips North America Llc
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II
Medical Device Recall · August 13, 2025
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
The device does not bear a unique device identifier.
Class III
Medical Device Recall · August 13, 2025
Philips North America Llc
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
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Class II
Medical Device Recall · August 13, 2025
Penner Patient Care, Inc.
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
The device does not bear a unique device identifier.
Class III
Medical Device Recall · August 13, 2025
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
The device does not bear a unique device identifier.
Class III
Medical Device Recall · August 13, 2025
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
The device does not bear a unique device identifier.
Class III
Medical Device Recall · August 12, 2025
Applied Medical Technology Inc
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intesti
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Class II
Medical Device Recall · August 12, 2025
Max Mobility LLC
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
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.
Class I
Medical Device Recall · August 12, 2025
Siemens Medical Solutions USA, Inc
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Limited system movements after startup .
Class II
Medical Device Recall · August 12, 2025
Max Mobility LLC
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
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.
Class I
Medical Device Recall · August 12, 2025
Max Mobility LLC
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
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.
Class I
Medical Device Recall · August 12, 2025
Applied Medical Technology Inc
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intesti
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Class II
Medical Device Recall · August 12, 2025
Applied Medical Technology Inc
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 intesti
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Class II
Medical Device Recall · August 12, 2025
Applied Medical Technology Inc
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 intesti
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Class II
Medical Device Recall · August 11, 2025
Merge Healthcare, Inc.
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that m
Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client (Pressure Sensor Defective) during non-invasive blood pressure (NIBP) measurements, specifically when the initial inflation pressure is set in the high-pressure range (>240 mmHg). The ARGUS PB-3000 is a vital signs monitoring instrument intended to be integrated into the Merge Hemo System. No other components of the Merge Hemo System are affected.
Class II
Medical Device Recall · August 11, 2025
Agilent Technologies Denmark ApS
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mou
Their is the potential for weak staining which may result in false negative CD20 identification.
Class II
Medical Device Recall · August 11, 2025
Siemens Healthcare Diagnostics, Inc.
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Class II
Medical Device Recall · August 11, 2025
Agilent Technologies Denmark ApS
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse
Their is the potential for weak staining which may result in false negative CD20 identification.
Class II
Medical Device Recall · August 11, 2025
Agilent Technologies Denmark ApS
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mous
Their is the potential for weak staining which may result in false negative CD20 identification.
Class II
Medical Device Recall · August 8, 2025
RAYSEARCH LABORATORIES AB
RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Versi
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class II
Medical Device Recall · August 8, 2025
Baxter Healthcare Corporation
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
Class II
Medical Device Recall · August 8, 2025
RAYSEARCH LABORATORIES AB
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Servic
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class II
Medical Device Recall · August 8, 2025
Philips Medical Systems Nederland B.V.
IntelliSpace Cardiovascular, Software 8.0.0.4.
Software issue that results in the display of outdated information.
Class II
Medical Device Recall · August 8, 2025
RAYSEARCH LABORATORIES AB
RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Rad
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class II
Medical Device Recall · August 8, 2025
RAYSEARCH LABORATORIES AB
RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software V
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class II
Medical Device Recall · August 8, 2025
Greiner Bio-One North America, Inc.
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.
Class II
Medical Device Recall · August 8, 2025
Schiller, Ag
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.
Class II
Medical Device Recall · August 8, 2025
Medline Industries, LP
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Convenience kits labeled as sterile have not gone through the sterilization process.
Class I
Medical Device Recall · August 8, 2025
RAYSEARCH LABORATORIES AB
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2,
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class II
Medical Device Recall · August 8, 2025
RAYSEARCH LABORATORIES AB
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class II
Medical Device Recall · August 8, 2025
RAYSEARCH LABORATORIES AB
RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software V
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class II
Medical Device Recall · August 8, 2025
RAYSEARCH LABORATORIES AB
RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Serv
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class II
Medical Device Recall · August 8, 2025
Medline Industries, LP
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
Convenience kits labeled as sterile have not gone through the sterilization process.
Class I
Medical Device Recall · August 8, 2025
RAYSEARCH LABORATORIES AB
RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Servic
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class II
Medical Device Recall · August 7, 2025
Flosonics Medical (R/A 1929803 ONTARIO CORP.)
FloPatch FP120, REF: FP120-FOT01-005
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.
Class III
Medical Device Recall · August 6, 2025
Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
The catheters may not retain their shape.
Class I
Medical Device Recall · August 6, 2025
ICU Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Class II
Medical Device Recall · August 6, 2025
Maquet Cardiovascular, LLC
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting ki
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.
Class II
Medical Device Recall · August 6, 2025
Cepheid
Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be us
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Class II