Medical Device Recalls
RSS ↗7,979 medical device recalls from federal enforcement feeds.
Showing 6,251–6,300 of 7,979
- Class I
Medical Device Recall · April 29, 2024
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-UTeleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
- Class II
Medical Device Recall · April 26, 2024
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R;The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH.
- Class II
Medical Device Recall · April 26, 2024
Centers For Disease Control and Prevention
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11The H5b component may fail to amplify, resulting in an inconclusive result.
- Class II
Medical Device Recall · April 26, 2024
Medtronic Navigation, Inc.-Littleton
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.
- Class II
Medical Device Recall · April 25, 2024
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx OnlyDue to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
- Class II
Medical Device Recall · April 25, 2024
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay
- Class II
Medical Device Recall · April 24, 2024
Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 1The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal.
- Class II
Medical Device Recall · April 24, 2024
smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4Packaging contained the incorrect size of femoral head from what was displayed on the label.
- Class II
Medical Device Recall · April 24, 2024
MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube displayWe have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC HDMI or MNA-4x0 ENC HDMI. In some instances, this connection may render the first HDMI channel inaccessible, making both the channel and the respective MNA ENC unit unusable. Additionally, readings from the module become unavailable when this issue arises. Similarly, when this Molex module is connected to the ETH0 slot of an MNA-620 ENC ANA, readings may also become inaccessible.
- Class II
Medical Device Recall · April 24, 2024
Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 1The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal.
- Class II
Medical Device Recall · April 24, 2024
Olympus Corporation of the Americas
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displaysA subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical current flowing to the earth is within standard limits
- Class II
Medical Device Recall · April 23, 2024
Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog:Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 23, 2024
Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog: 90185 Trevo XP ProVue Retriever 6 x 25, Catalog: 90186Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 23, 2024
Trevo Trak 21 Microcatheter, Catalog: 90338Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 23, 2024
FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 23, 2024
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.
- Class II
Medical Device Recall · April 23, 2024
Mckesson Medical-Surgical Inc. Corporate Office
Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal Catalog Number: 8881560125Quarantined product was inadvertently distributed
- Class II
Medical Device Recall · April 23, 2024
DAC 044 115cm, Catalog: 90760Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 23, 2024
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.Some applicator tips from these lots had open seals.
- Class II
Medical Device Recall · April 23, 2024
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab.
- Class II
Medical Device Recall · April 23, 2024
Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 23, 2024
Trevo ProVue, Catalog: 90184Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 23, 2024
Cascade IOMAX Cortical Module, REF: 190296-200There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.
- Class II
Medical Device Recall · April 23, 2024
Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310 SYNCHRO .010 WIRE SOFT STNeurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Class II
Medical Device Recall · April 22, 2024
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part NumWondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
- Class II
Medical Device Recall · April 22, 2024
ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/AAlcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
- Class II
Medical Device Recall · April 22, 2024
ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/AAlcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
- Class II
Medical Device Recall · April 22, 2024
Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, StWondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
- Class II
Medical Device Recall · April 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
- Class II
Medical Device Recall · April 22, 2024
Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMCWondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
- Class II
Medical Device Recall · April 22, 2024
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/AAlcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
- Class II
Medical Device Recall · April 22, 2024
GE Medical Systems Information Technologies Inc
Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spareCapacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.
- Class II
Medical Device Recall · April 22, 2024
Mirion Technologies (Capintec), Inc.
Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.Complaints of unexpected detachment of the collimator have been reported.
- Class II
Medical Device Recall · April 22, 2024
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rateDuring the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.
- Class II
Medical Device Recall · April 22, 2024
Mirion Technologies (Capintec), Inc.
Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.Complaints of unexpected detachment of the collimator have been reported.
- Class II
Medical Device Recall · April 22, 2024
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
- Class II
Medical Device Recall · April 22, 2024
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
- Class II
Medical Device Recall · April 22, 2024
ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/AAlcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
- Class II
Medical Device Recall · April 22, 2024
Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
- Class II
Medical Device Recall · April 22, 2024
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
- Class II
Medical Device Recall · April 22, 2024
Mirion Technologies (Capintec), Inc.
Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.Complaints of unexpected detachment of the collimator have been reported.
- Class II
Medical Device Recall · April 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
- Class II
Medical Device Recall · April 19, 2024
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.Event Catalog information does not save when copied and transferred from one unit to another.
- Class II
Medical Device Recall · April 18, 2024
MED-EL Elektromedizinische Gereate, Gmbh
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear ImplantA small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.
- Class II
Medical Device Recall · April 18, 2024
Boston Scientific Neuromodulation Corporation
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.
- Class II
Medical Device Recall · April 18, 2024
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentraWhen the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.
- Class II
Medical Device Recall · April 18, 2024
OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MMExactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Class II
Medical Device Recall · April 18, 2024
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MMExactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Class II
Medical Device Recall · April 18, 2024
The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014in. The guStryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.
- Class II
Medical Device Recall · April 18, 2024
Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.