Medical Device Recalls
RSS ↗7,979 medical device recalls from federal enforcement feeds.
Showing 7,101–7,150 of 7,979
- Class II
Medical Device Recall · February 16, 2024
Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010ALow concentration of sodium pyruvate in the wash could compromise gamete development
- Class II
Medical Device Recall · February 16, 2024
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060DLow concentration of sodium pyruvate in the wash could compromise gamete development
- Class II
Medical Device Recall · February 16, 2024
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090There is a potential for sterile package breach.
- Class II
Medical Device Recall · February 15, 2024
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a patient condition which prompted the alarm to generate. Although unlikely, this could potentially result in a patient harm.
- Class II
Medical Device Recall · February 15, 2024
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- Class II
Medical Device Recall · February 15, 2024
Augustine Temperature Management, LLC
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
- Class II
Medical Device Recall · February 15, 2024
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- Class II
Medical Device Recall · February 15, 2024
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS KitDue to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
- Class II
Medical Device Recall · February 15, 2024
Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- Class II
Medical Device Recall · February 15, 2024
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- Class II
Medical Device Recall · February 15, 2024
SEASPINE ORTHOPEDICS CORPORATION
Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050;Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
- Class II
Medical Device Recall · February 15, 2024
Augustine Temperature Management, LLC
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
- Class II
Medical Device Recall · February 14, 2024
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVTUnder certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
- Class II
Medical Device Recall · February 14, 2024
HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-0Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy.
- Class II
Medical Device Recall · February 14, 2024
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVTUnder certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
- Class II
Medical Device Recall · February 14, 2024
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.
- Class II
Medical Device Recall · February 14, 2024
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
- Class I
Medical Device Recall · February 13, 2024
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECARTDeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
- Class II
Medical Device Recall · February 12, 2024
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060SEndotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
- Class II
Medical Device Recall · February 12, 2024
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070SEndotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
- Class I
Medical Device Recall · February 12, 2024
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU;Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.
- Class I
Medical Device Recall · February 12, 2024
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).
- Class II
Medical Device Recall · February 12, 2024
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic SystemThere is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.
- Class II
Medical Device Recall · February 9, 2024
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.
- Class II
Medical Device Recall · February 8, 2024
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot or any otherbdosimeter for medical applications from the product s user manual and software and to remove microStar readers from customers who use them only for medical applications.
- Class II
Medical Device Recall · February 8, 2024
Access Total T4, REF 33800, IVD, thyroxine reagent assay.Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.
- Class II
Medical Device Recall · February 8, 2024
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results.
- Class II
Medical Device Recall · February 8, 2024
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber.
- Class II
Medical Device Recall · February 8, 2024
Chromophare Surgical Light System , REF CH00000001Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
- Class II
Medical Device Recall · February 8, 2024
Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wireDue to a change in the safety clips for the heated eye masks, the wires to the safety clips may detach as a result of tugging and pulling and may cause a short in the heating element of the mask and could potentially cause burn injuries.
- Class II
Medical Device Recall · February 7, 2024
Medtronic DLP Vessel Cannula, Model Number REF 30000Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
- Class I
Medical Device Recall · February 7, 2024
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUSWhen a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.
- Class II
Medical Device Recall · February 7, 2024
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples andTorrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow them to alter settings, configurations, software, or data on the instrument
- Class II
Medical Device Recall · February 7, 2024
Siemens Healthcare Diagnostics, Inc.
DCA Systems HbA1c Reagent KitThe reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported and potentially lead to incorrect patient management of glucose control. A positive bias may be observed with eleven HbA1c affected lots. Positive bias was observed when the performance of these five HbA1c lots was compared to NGSP pooled patient target-value assigned samples and the maximum bias observed was 19%.
- Class I
Medical Device Recall · February 7, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUSWhen a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.
- Class II
Medical Device Recall · February 7, 2024
TENSIVE Conductive Adhesive Gel, REF 016-401600Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Number A0623009. They have received five complaints. These customers reported that the gel is too thick, is discolored (darker than usual), and in one instance, patients reported irritation after procedures using the gel.
- Class II
Medical Device Recall · February 7, 2024
natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Number A0623009. They have received five complaints. These customers reported that the gel is too thick, is discolored (darker than usual), and in one instance, patients reported irritation after procedures using the gel.
- Class II
Medical Device Recall · February 7, 2024
Access Substrate, REF 81906, For use with the Access Immunoassay SystemsOn 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, and 338538. Beckman Coulter has identified that Access Substrate bottles in the identified lots were released from manufacturing without labels. Missing label may cause some patient results reporting delay but will not cause any errorreous results. However, because labs are required to have redundancy such that delay would not significantly impact clinical management and because the defect is easily recognized by the user, the probability of harm is remote.
- Class II
Medical Device Recall · February 6, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
- Class II
Medical Device Recall · February 6, 2024
X3 TRIATHLON CS INSERT NO 7 9 MMPotential packaging breaches of inner blister and outer sterile blister.
- Class II
Medical Device Recall · February 6, 2024
NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MMPotential packaging breaches of inner blister and outer sterile blister.
- Class II
Medical Device Recall · February 6, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
- Class II
Medical Device Recall · February 6, 2024
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MMPotential packaging breaches of inner blister and outer sterile blister.
- Class II
Medical Device Recall · February 6, 2024
Waldemar Link GmbH & Co. KG (Mfg Site)
SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cementedDue to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
- Class II
Medical Device Recall · February 6, 2024
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MMPotential packaging breaches of inner blister and outer sterile blister.
- Class II
Medical Device Recall · February 6, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
- Class II
Medical Device Recall · February 6, 2024
X3 TRIATHLON CS INSERT NO 6 11 MMPotential packaging breaches of inner blister and outer sterile blister.
- Class II
Medical Device Recall · February 6, 2024
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MMPotential packaging breaches of inner blister and outer sterile blister.
- Class II
Medical Device Recall · February 6, 2024
Waldemar Link GmbH & Co. KG (Mfg Site)
SPII Model Lubinus, Long Stem Prosthesis XL Neck, cementedDue to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
- Class II
Medical Device Recall · February 6, 2024
Waldemar Link GmbH & Co. KG (Mfg Site)
SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cementedDue to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.