Medical Device Recalls

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8,689 medical device recalls from federal enforcement feeds.

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Showing 4,701–4,750 of 8,689

Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog Number: 770708042
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708122 Product Descripti
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708061
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Class II
Medical Device Recall · January 21, 2025
Physio-Control, Inc.
LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor REF 119
Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715101
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for Fixation of fractures of the distal tibia
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation of fractures of the distal tibia Model/Catalog Number: 77070802
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal tibia. Model/Catalog Number: 770715102
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 770708062
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708041
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715061
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770708102 Product Description
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone fragments to facilitate healing. Model/Catalog Number: 77070808
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Class II
Medical Device Recall · January 20, 2025
Microbiologics Inc
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
Class II
Medical Device Recall · January 20, 2025
Microbiologics Inc
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
Class II
Medical Device Recall · January 17, 2025
KCI USA, INC.
3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Ship
Due to increase in complaints related to leak alarms
Class II
Medical Device Recall · January 17, 2025
Zhejiang Luyao Electronics Technology Co., Ltd.
Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massager used on the leg. The Air Compression Leg Mass
Regulatory documentation error and misleading color packaging claim.
Class II
Medical Device Recall · January 17, 2025
KCI USA, INC.
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena
Due to increase in complaints related to leak alarms
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Serv
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Servic
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B,
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1,
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
Scientia Vascular, Inc.
Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during inte
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Class II
Medical Device Recall · January 16, 2025
Spectrum Medical Inc
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version:
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Servi
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 15, 2025
Philips North America Llc
IntelliVue Patient Monitor MX500. Model Number: 866064
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Class II
Medical Device Recall · January 15, 2025
Hologic, Inc
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Class II
Medical Device Recall · January 15, 2025
DeRoyal Industries Inc
DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care.
Class II
Medical Device Recall · January 15, 2025
Philips North America Llc
IntelliVue Patient Monitor MX550. Model Number: 866066
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Class II
Medical Device Recall · January 15, 2025
Olympus Corporation of the Americas
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush;
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Class I
Medical Device Recall · January 15, 2025
Philips North America Llc
IntelliBridge EC10 Module. Model Number: 865115
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Class II
Medical Device Recall · January 15, 2025
TERRAGENE S.A.
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Class II
Medical Device Recall · January 15, 2025
Philips North America Llc
IntelliVue Patient Monitor MX450. Model Number: 866062
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Class II
Medical Device Recall · January 15, 2025
Elekta, Inc.
MOSAIQ Oncology Information System
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Class II
Medical Device Recall · January 15, 2025
Getinge Usa Sales Inc
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
Class I
Medical Device Recall · January 15, 2025
Philips North America Llc
IntelliVue Patient Monitor MX400. Model Number: 866060
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Class II
Medical Device Recall · January 14, 2025
Draeger Medical Systems, Inc.
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinica
Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.
Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; Catalog numbers: 722038
Possibility of the patient falling from the table related to the mattress used on the patient table.
Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
Possibility of the patient falling from the table related to the mattress used on the patient table.
Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
Possibility of the patient falling from the table related to the mattress used on the patient table.
Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/10; Catalog numbers: 722029
Possibility of the patient falling from the table related to the mattress used on the patient table.
Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15; Catalog numbers: 722058
Possibility of the patient falling from the table related to the mattress used on the patient table.
Class I