May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.5T Master/Nova, Model Number: 781106;
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.5T, Model Numbers: 781195 and 781295;
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.0T Power/Pulsar, Model Number: 781103;
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.0T Omni/Stellar, Model Number: 781102;
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 0.5T Standard, Model Number: 781101;
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Enterprise 1.5T, Model Number: 781145;
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
May 21, 2025Medical DevicesFDA
Klinika Mdical Gmb recalls KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F
Hazard: Potential for microbial contamination.
May 21, 2025Medical DevicesFDA
Klinika Mdical Gmb recalls KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device Kl
Hazard: Potential for microbial contamination.
May 21, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
Hazard: Three is the potential for the retractors to puncture through the sterile packaging.
May 21, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Sterile Weitlaner Retractor, Reorder: 67315
Hazard: Three is the potential for the retractors to puncture through the sterile packaging.
May 21, 2025Medical DevicesFDA
Contec Medical Systems Co., Ltd. recalls CMS8000 Patient Monitor
Hazard: Patient monitor has nine identified cybersecurity vulnerabilities.
May 21, 2025Medical DevicesFDA
ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Hazard: Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
May 21, 2025Medical DevicesFDA
Cook Incorporated recalls Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and
Hazard: Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
May 21, 2025Medical DevicesFDA
Augmedics Ltd. recalls Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guid
Hazard: The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
May 21, 2025Medical DevicesFDA
Numed Inc recalls BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Hazard: Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
May 21, 2025Medical DevicesFDA
Richard Wolf GmbH recalls PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables t
Hazard: The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.
May 21, 2025Medical DevicesFDA
LeMaitre Vascular, Inc. recalls Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
Hazard: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
May 21, 2025Medical DevicesFDA
LeMaitre Vascular, Inc. recalls Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
Hazard: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
May 21, 2025Medical DevicesFDA
LeMaitre Vascular, Inc. recalls TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1
Hazard: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
May 21, 2025Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain
Hazard: There were reports of an increase in reactive negative controls and false positive results.
May 21, 2025Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (
Hazard: There were reports of an increase in reactive negative controls and false positive results.
May 21, 2025Medical DevicesFDA
Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
Hazard: Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
May 21, 2025Medical DevicesFDA
Meddev Corp recalls Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contou
Hazard: Due to mislabeling of products
May 21, 2025Medical DevicesFDA
Meddev Corp recalls Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contou
Hazard: Due to mislabeling of products
May 21, 2025Medical DevicesFDA
AVID Medical, Inc. recalls Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
Hazard: An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
May 21, 2025Medical DevicesFDA
AVID Medical, Inc. recalls Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
Hazard: An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
May 21, 2025Medical DevicesFDA
AVID Medical, Inc. recalls Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
Hazard: An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
May 21, 2025Medical DevicesFDA
Nipro Renal Soultions USA, Corporation recalls MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in cor
Hazard: Potential for the presence of visible foreign matter.
May 21, 2025Medical DevicesFDA
Medical Depot Inc. recalls iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate t
Hazard: Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.