Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 3,251–3,300 of 8,689
- Class II
Medical Device Recall · August 18, 2025
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
- Class II
Medical Device Recall · August 18, 2025
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
- Class II
Medical Device Recall · August 18, 2025
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
- Class II
Medical Device Recall · August 18, 2025
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
- Class II
Medical Device Recall · August 15, 2025
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
- Class II
Medical Device Recall · August 15, 2025
Mindray DS USA, Inc. dba Mindray North America
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016,Potential for activation of an abnormal alarm pause.
- Class II
Medical Device Recall · August 15, 2025
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.Potential for barb non-engagement.
- Class II
Medical Device Recall · August 15, 2025
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEReverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
- Class II
Medical Device Recall · August 15, 2025
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 3Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
- Class II
Medical Device Recall · August 15, 2025
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
- Class II
Medical Device Recall · August 15, 2025
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
- Class II
Medical Device Recall · August 13, 2025
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 III
Medical Device Recall · August 13, 2025
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, 370000-2WThe device does not bear a unique device identifier.
- Class II
Medical Device Recall · August 13, 2025
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478Hematology 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 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
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
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
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.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Class III
Medical Device Recall · August 13, 2025
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2The device does not bear a unique device identifier.
- Class II
Medical Device Recall · August 13, 2025
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322Hematology 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 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
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: 728317The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Class III
Medical Device Recall · August 13, 2025
Penner Pacific Bathing Spa, Model Numbers 360020-1EPThe device does not bear a unique device identifier.
- Class II
Medical Device Recall · August 13, 2025
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
- Class III
Medical Device Recall · August 13, 2025
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-XThe device does not bear a unique device identifier.
- Class III
Medical Device Recall · August 13, 2025
Penner Pacific Bathing Spa, Model Numbers 860010-1LThe device does not bear a unique device identifier.
- Class II
Medical Device Recall · August 13, 2025
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Class III
Medical Device Recall · August 13, 2025
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XLThe device does not bear a unique device identifier.
- Class II
Medical Device Recall · August 13, 2025
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
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520Hematology 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
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Softwareit 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 III
Medical Device Recall · August 13, 2025
Penner Pacific Bathing Spa, Model Numbers 360020-1PThe device does not bear a unique device identifier.
- Class III
Medical Device Recall · August 13, 2025
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, 36The device does not bear a unique device identifier.
- Class II
Medical Device Recall · August 13, 2025
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
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Radiology Solutions software version 14.2.2Due to software issue, radiology reports may not be fully displayed when viewing.
- Class III
Medical Device Recall · August 13, 2025
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1The device does not bear a unique device identifier.
- Class III
Medical Device Recall · August 13, 2025
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-XThe device does not bear a unique device identifier.
- Class II
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
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 intestiThe 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 intestiThe 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 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 intestiThe 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 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 intestiThe nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
- Class I
Medical Device Recall · August 12, 2025
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/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
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 II
Medical Device Recall · August 11, 2025
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 mMerge 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
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 MouseTheir 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: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal MouTheir 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 MousTheir is the potential for weak staining which may result in false negative CD20 identification.