February 4, 2026Medical DevicesFDA
Aju Pharm Co., Ltd. recalls Fixone Hybrid Anchor
Hazard: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
February 4, 2026Medical DevicesFDA
Cerapedics, Inc. recalls PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010
Hazard: Incorrect expiration date
February 4, 2026Medical DevicesFDA
Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
Hazard: Due to a manufacturing issue and electrical grounding of systems.
February 4, 2026Medical DevicesFDA
SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Versio
Hazard: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
February 4, 2026Medical DevicesFDA
SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Ve
Hazard: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
February 4, 2026Medical DevicesFDA
SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Ve
Hazard: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
February 4, 2026Medical DevicesFDA
SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software V
Hazard: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
January 28, 2026Medical DevicesFDA
GVS TM, Inc recalls SQ40S Blood Transfusion Filter
Hazard: Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
January 28, 2026Medical DevicesFDA
Philips North America recalls Patient Information Center iX; Software Version Number: 4.5.0
Hazard: A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects ph
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Mon
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Mon
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Descript
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS i
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX ser
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monit
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Descriptio
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three w
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Moni
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product
Hazard: 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.
January 28, 2026Medical DevicesFDA
Edan Diagnostics recalls Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedsid
Hazard: 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.
January 28, 2026Medical DevicesFDA
Community Products, LLC recalls Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjus
Hazard: Potential for fraying on the body support strap.
January 28, 2026Medical DevicesFDA
Community Products, LLC recalls Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clien
Hazard: Potential for fraying on the body support strap.
January 28, 2026Medical DevicesFDA
Community Products, LLC recalls Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a s
Hazard: Potential for fraying on the body support strap.
January 28, 2026Medical DevicesFDA
Sysmex America, Inc. recalls TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running s
Hazard: Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
January 28, 2026Medical DevicesFDA
Beckman Coulter Ireland, Inc. recalls The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol f
Hazard: Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).