Medical Device Recalls

7,959 medical device recalls from federal enforcement feeds.

Showing 1,951–2,000 of 7,959

• Medical Device Recall · October 24, 2025

  Edan Diagnostics

  Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, includi

  As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

  Class II

• Medical Device Recall · October 24, 2025

  Edan Diagnostics

  Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vita

  As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

  Class II

• Medical Device Recall · October 24, 2025

  Edan Diagnostics

  Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are int

  As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

  Class II

• Medical Device Recall · October 23, 2025

  Becton Dickinson & Co.

  BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;

  The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.

  Class II

• Medical Device Recall · October 23, 2025

  Datascope Corp.

  Cardiosave Rescue

  The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

  Class III

• Medical Device Recall · October 23, 2025

  Datascope Corp.

  Cardiosave Hybrid

  The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

  Class III

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat, 5 mm, 45 cm Inline Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  BioFire Diagnostics, LLC

  BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

  Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat 5 mm, 10 cm, Inline Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 21, 2025

  Medtronic MiniMed, Inc.

  CareLink Clinic, REF: MMT-7350

  Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.

  Class II

• Medical Device Recall · October 21, 2025

  Accriva Diagnostics, Inc.

  VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of

  Due to an device without a premarket clearance being incorrectly package and distributed.

  Class III

• Medical Device Recall · October 20, 2025

  Medtronic Perfusion Systems

  Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

  Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.

  Class II

• Medical Device Recall · October 20, 2025

  Mindray DS USA, Inc. dba Mindray North America

  Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (

  Potential for anesthesia leakage.

  Class II

• Medical Device Recall · October 20, 2025

  Mindray DS USA, Inc. dba Mindray North America

  Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Sa

  Potential for anesthesia leakage.

  Class II

• Medical Device Recall · October 18, 2025

  Auris Health, Inc

  MONARCH Bronchoscope. Model Number: MBR-000211-B

  Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.

  Class II

• Medical Device Recall · October 17, 2025

  Mozarc Medical US LLC

  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;

  A potential issue with the seal integrity of header bag packaging.

  Class II

• Medical Device Recall · October 17, 2025

  Mozarc Medical US LLC

  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;

  A potential issue with the seal integrity of header bag packaging.

  Class II

• Medical Device Recall · October 17, 2025

  Mozarc Medical US LLC

  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;

  A potential issue with the seal integrity of header bag packaging.

  Class II

• Medical Device Recall · October 17, 2025

  Straumann USA LLC

  Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

  The possibility for this product that is intended for demonstration purposes only to be placed in patients.

  Class II

• Medical Device Recall · October 17, 2025

  Mozarc Medical US LLC

  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;

  A potential issue with the seal integrity of header bag packaging.

  Class II

• Medical Device Recall · October 17, 2025

  Mozarc Medical US LLC

  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;

  A potential issue with the seal integrity of header bag packaging.

  Class II

• Medical Device Recall · October 17, 2025

  INTELERAD MEDICAL SYSTEMS INCORPORATED

  IntelePACS - InteleConnect / TechPortal

  Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.

  Class II

• Medical Device Recall · October 17, 2025

  TECHNO-PATH MANUFACTURING LTD.

  Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of

  Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.

  Class II

• Medical Device Recall · October 17, 2025

  TECHNO-PATH MANUFACTURING LTD.

  Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determinat

  Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.

  Class II

• Medical Device Recall · October 17, 2025

  CareFusion 303, Inc.

  BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris

  If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.

  Class I

• Medical Device Recall · October 17, 2025

  Olympus Corporation of the Americas

  Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: Th

  Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.

  Class II

• Medical Device Recall · October 17, 2025

  Mozarc Medical US LLC

  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;

  A potential issue with the seal integrity of header bag packaging.

  Class II

• Medical Device Recall · October 16, 2025

  SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

  Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and co

  Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.

  Class II

• Medical Device Recall · October 16, 2025

  Canon Medical System, USA, INC.

  VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

  Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.

  Class II

• Medical Device Recall · October 14, 2025

  Beckman Coulter Ireland, Inc.

  BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU

  Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.

  Class II

• Medical Device Recall · October 14, 2025

  Olympus Corporation of the Americas

  Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system

  Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.

  Class II

• Medical Device Recall · October 14, 2025

  Becton Dickinson & Company

  BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;

  BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.

  Class II

• Medical Device Recall · October 13, 2025

  DERMASENSOR INC

  DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer

  Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.

  Class II

• Medical Device Recall · October 13, 2025

  Paragon 28, Inc.

  Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

  Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.

  Class II

• Medical Device Recall · October 13, 2025

  MRIMed Inc.

  MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light

  Due to battery component overheating while charging resulting in melting of internal components and causing smoke.

  Class II

• Medical Device Recall · October 13, 2025

  TMJ Solutions Inc

  TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

  Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.

  Class I

• Medical Device Recall · October 10, 2025

  Thoratec LLC

  CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 20

  Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.

  Class II

• Medical Device Recall · October 10, 2025

  Medline Industries, LP

  Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230

  Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

  Class I

• Medical Device Recall · October 10, 2025

  Medline Industries, LP

  Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE

  Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

  Class I

• Medical Device Recall · October 10, 2025

  Medline Industries, LP

  Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA655

  Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

  Class I