Medical Device Recalls

8,689 medical device recalls from federal enforcement feeds.

Showing 2,651–2,700 of 8,689

• Medical Device Recall · October 27, 2025

  Medline Industries, LP

  Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS

  Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

  Class II

• Medical Device Recall · October 25, 2025

  Fresenius Medical Care Holdings, Inc.

  5008X CAREsystem +CLiC +CDX;

  Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

  Class II

• Medical Device Recall · October 24, 2025

  Edan Diagnostics

  Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring

  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: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-t

  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: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can p

  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: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used

  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: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiolo

  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: 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: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information

  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: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applicatio

  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: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous

  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

  Siemens Medical Solutions USA, Inc

  MAMMOMAT Revelation;

  There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

  Class II

• Medical Device Recall · October 24, 2025

  Edan Diagnostics

  Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous

  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: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The moni

  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

  GE Medical Systems, LLC

  Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

  Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).

  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 24, 2025

  Edan Diagnostics

  Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological param

  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: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyz

  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: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The mon

  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

  Siemens Medical Solutions USA, Inc

  MAMMOMAT Inspiration;

  There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

  Class II

• Medical Device Recall · October 24, 2025

  Siemens Medical Solutions USA, Inc

  MAMMOMAT Fusion;

  There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

  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

  Nuclein LLC

  Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 Product Description: The DASH¿ Rapid PCR In

  Due to a software issue

  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 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, 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, 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, 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

  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, 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, 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, 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, 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 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, 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, 20 cm, Inline 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

  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 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 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

  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

  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

  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 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

  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