Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-05-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIIntera 1.5T Master/Nova, Model Number: 781106;
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.
- 2025-05-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIIntera 1.5T Explorer/Nova Dual, Model Number: 781108;
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.
- 2025-05-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIIntera 1.5T, Model Numbers: 781195 and 781295;
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.
- 2025-05-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIIntera 1.0T Power/Pulsar, Model Number: 781103;
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.
- 2025-05-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIIntera 1.0T Omni/Stellar, Model Number: 781102;
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.
- 2025-05-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIIntera 0.5T Standard, Model Number: 781101;
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.
- 2025-05-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIEnterprise 1.5T, Model Number: 781145;
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.
- 2025-05-21FDA-DeviceKlinika Mdical GmbClass IIKliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
Potential for microbial contamination.
- 2025-05-21FDA-DeviceKlinika Mdical GmbClass IIKliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
Potential for microbial contamination.
- 2025-05-21FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
Three is the potential for the retractors to puncture through the sterile packaging.
- 2025-05-21FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion Sterile Weitlaner Retractor, Reorder: 67315
Three is the potential for the retractors to puncture through the sterile packaging.
- 2025-05-21FDA-DeviceContec Medical Systems Co., Ltd.Class IICMS8000 Patient Monitor
Patient monitor has nine identified cybersecurity vulnerabilities.
- 2025-05-21FDA-DeviceICU Medical, Inc.Class IILifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
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.
- 2025-05-21FDA-DeviceCook IncorporatedClass IITornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357)
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
- 2025-05-21FDA-DeviceAugmedics Ltd.Class IIAugmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
- 2025-05-21FDA-DeviceNumed IncClass IIBIB Balloon in Balloon Dilatation Catheter. Model Number: 420
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.
- 2025-05-21FDA-DeviceRichard Wolf GmbHClass IIPiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
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.
- 2025-05-21FDA-DeviceLeMaitre Vascular, Inc.Class IIPruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- 2025-05-21FDA-DeviceLeMaitre Vascular, Inc.Class IIPruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- 2025-05-21FDA-DeviceLeMaitre Vascular, Inc.Class IITufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- 2025-05-21FDA-DeviceAbbott Molecular, Inc.Class IIAlinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare
There were reports of an increase in reactive negative controls and false positive results.
- 2025-05-21FDA-DeviceAbbott Molecular, Inc.Class IIAlinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection
There were reports of an increase in reactive negative controls and false positive results.
- 2025-05-21FDA-DeviceFoundation Medicine, Inc.Class IIFoundationOne Companion Diagnostic (F1CDx)
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.
- 2025-05-21FDA-DeviceMeddev CorpClass IIBrand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contour Gold Eyelid Weight, 1.2 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.
Due to mislabeling of products
- 2025-05-21FDA-DeviceMeddev CorpClass IIBrand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight, 1.0 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.
Due to mislabeling of products
- 2025-05-21FDA-DeviceAVID Medical, Inc.Class IIHalyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
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.
- 2025-05-21FDA-DeviceAVID Medical, Inc.Class IIHalyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
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.
- 2025-05-21FDA-DeviceAVID Medical, Inc.Class IIHalyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
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.
- 2025-05-21FDA-DeviceNipro Renal Soultions USA, CorporationClass IMedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
Potential for the presence of visible foreign matter.
- 2025-05-21FDA-DeviceMedical Depot Inc.Class IiGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief