Medical Device Recalls

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7,979 medical device recalls from federal enforcement feeds.

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Showing 5,101–5,150 of 7,979

Medical Device Recall · August 29, 2024
Wilson-Cook Medical Inc.
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal
Specific lots of product have been manufactured with nonconforming raw materials.
Class II
Medical Device Recall · August 29, 2024
Tornier, Inc
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Class II
Medical Device Recall · August 29, 2024
CooperVision, Inc.
Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Class II
Medical Device Recall · August 29, 2024
Microcare Medical
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1, GVUS24-1, GVUS24-1
Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic detergent, which caused product bloating/leaking, and if used during medical/dental procedures could result in urinary tract, respiratory, bloodstream infections; workers handling contaminated product/instruments also at risk
Class II
Medical Device Recall · August 29, 2024
CooperVision, Inc.
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Class II
Medical Device Recall · August 28, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE OPEN HEART PACK, REF DYNJ66216C
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Class II
Medical Device Recall · August 28, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Class II
Medical Device Recall · August 28, 2024
Beckman Coulter, Inc.
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human
Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
Class II
Medical Device Recall · August 28, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Class II
Medical Device Recall · August 28, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE HEART CABG CDS, REF CDS983376R
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Class II
Medical Device Recall · August 28, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE KIT CV I II, REF DYNJ906071B
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Class II
Medical Device Recall · August 28, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE OPEN HEART, REF DYNJ904261B
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Class II
Medical Device Recall · August 28, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues, organs, and calculi during general and laparoscopic procedures. The tube inside the pouch, which detaches during the removal process, may stretch out from the pouch opening if it is not precisely fixed during the production process. Medline has identified that this product is utilized as a component within the Medline-branded convenience kits.
Class II
Medical Device Recall · August 27, 2024
Safeguard US Operating LLC
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Incorrect expiration date.
Class II
Medical Device Recall · August 27, 2024
Safeguard US Operating LLC
HAWK Warming Grid, Item Number: 59-300
Incorrect expiration date.
Class II
Medical Device Recall · August 27, 2024
Safeguard US Operating LLC
Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set. Convenience kits labeled
Incorrect expiration date.
Class II
Medical Device Recall · August 26, 2024
Nova Ortho-Med Inc
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit.
Class II
Medical Device Recall · August 26, 2024
Nova Ortho-Med Inc
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit.
Class II
Medical Device Recall · August 26, 2024
Qualigen Inc
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.
Class II
Medical Device Recall · August 26, 2024
Nova Ortho-Med Inc
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit.
Class II
Medical Device Recall · August 23, 2024
Young Dental Manufacturing I, LLC
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Class II
Medical Device Recall · August 23, 2024
WINGDERM ELECTRO-OPTICS LTD.
Diode Laser Hair Removal model: WLA-01
All model WLA-01 systems sold to US customers are found to have labeling non-compliances
Class II
Medical Device Recall · August 23, 2024
Olympus Corporation of the Americas
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
Class II
Medical Device Recall · August 23, 2024
WINGDERM ELECTRO-OPTICS LTD.
Non-ablative Fractional Laser Systems, Model: WFB-01
Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)
Class II
Medical Device Recall · August 23, 2024
Princeton Biomeditech Corp
Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004
This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced false negative test results from 2 patient urine samples as confirmed by quantitative hCG and ultrasound. During further root cause testing and investigation, an additional 6 devices were found to produce false negative test results from hCG positive samples.
Class II
Medical Device Recall · August 23, 2024
Stryker Spine
AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at
Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.
Class II
Medical Device Recall · August 22, 2024
Medtronic Navigation, Inc.
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures i
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
Class II
Medical Device Recall · August 22, 2024
Healgen Scientific Llc
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color
The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color fading on the total protein test pad. This could lead to a delay in the identification of potential kidney diseases, their evaluation, and/or other conditions associated with elevated protein levels in urine and subsequently a delay in patient treatment.
Class II
Medical Device Recall · August 22, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 Allura Xper FD20 OR Table 722029 Allura Xper FD20/10 7
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Class II
Medical Device Recall · August 22, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Class II
Medical Device Recall · August 22, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 72201
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Class II
Medical Device Recall · August 22, 2024
Kinova Inc
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.
Potential installation issue that could result in a fire hazard in the event of an interaction between a damaged Jaco arm and a wheelchair exhibiting electrical leakage.
Class I
Medical Device Recall · August 22, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost E
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Class II
Medical Device Recall · August 21, 2024
Medtronic Neuromodulation
Vanta Implantable Neurostimulator (INS), Model 977006
Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
Class II
Medical Device Recall · August 21, 2024
Percussionaire Corporation
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Class I
Medical Device Recall · August 21, 2024
Siemens Healthcare Diagnostics, Inc.
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
Class II
Medical Device Recall · August 21, 2024
XTANT Medical Holdings, Inc
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
Class II
Medical Device Recall · August 21, 2024
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.
Class II
Medical Device Recall · August 21, 2024
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
Class II
Medical Device Recall · August 21, 2024
Intuitive Surgical, Inc.
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure
Class II
Medical Device Recall · August 21, 2024
CHANGE HEALTHCARE CANADA COMPANY
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.
Class II
Medical Device Recall · August 21, 2024
Percussionaire Corporation
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Class I
Medical Device Recall · August 21, 2024
Olympus Corporation of the Americas
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
Class II
Medical Device Recall · August 21, 2024
CHANGE HEALTHCARE CANADA COMPANY
Horizon Cardiology Hemo. Version 12.2.
A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.
Class II
Medical Device Recall · August 20, 2024
Cypress Medical Products LLC
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Class II
Medical Device Recall · August 20, 2024
Ossur H / F
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing, possibly leading to reduced immobilization of the cervical spine.
Class II
Medical Device Recall · August 20, 2024
Cypress Medical Products LLC
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Class II
Medical Device Recall · August 20, 2024
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Class I
Medical Device Recall · August 20, 2024
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Class I
Medical Device Recall · August 20, 2024
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Class I