Medical Device Recalls
RSS ↗7,979 medical device recalls from federal enforcement feeds.
Showing 7,201–7,250 of 7,979
- Class II
Medical Device Recall · January 26, 2024
FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System, Catalog No. 6844458A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System, Catalog No. 6844461A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 25, 2024
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cementDue to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
- Class II
Medical Device Recall · January 25, 2024
Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.
- Class II
Medical Device Recall · January 25, 2024
SW Bari Lift & Transfer, Model Number 38060000Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.
- Class II
Medical Device Recall · January 25, 2024
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cementDue to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
- Class II
Medical Device Recall · January 24, 2024
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullarProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.
- Class II
Medical Device Recall · January 24, 2024
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15SProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
impression coping, repositionable, short, screw-retained, PF 4.0The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
- Class II
Medical Device Recall · January 24, 2024
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231SProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric andProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144SProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defecProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
Siemens Healthcare Diagnostics, Inc.
Atellica IM Erythropoietin (EPO) Assay (100 Test)Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.
- Class II
Medical Device Recall · January 24, 2024
TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944SProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621SProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25SProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.Product failed sterility testing.
- Class I
Medical Device Recall · January 23, 2024
Fresenius Medical Care Holdings, Inc.
stay-safe /Safe Lock Catheter Ext. 12 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Class I
Medical Device Recall · January 23, 2024
Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Adapter 4 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Class I
Medical Device Recall · January 23, 2024
Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Catheter Ext. 12 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Class I
Medical Device Recall · January 23, 2024
Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Catheter Ext. 18 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Class I
Medical Device Recall · January 23, 2024
Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Catheter Ext. 6 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Class I
Medical Device Recall · January 22, 2024
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce inPotential for catheter disconnection from the patient line stopcock connectors.
- Class I
Medical Device Recall · January 22, 2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracrPotential for catheter disconnection from the patient line stopcock connectors.
- Class II
Medical Device Recall · January 22, 2024
Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
- Class I
Medical Device Recall · January 22, 2024
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressurePotential for catheter disconnection from the patient line stopcock connectors.
- Class II
Medical Device Recall · January 22, 2024
Waldemar Link GmbH & Co. KG (Mfg Site)
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item NumberMislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
- Class I
Medical Device Recall · January 22, 2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce inPotential for catheter disconnection from the patient line stopcock connectors.
- Class I
Medical Device Recall · January 22, 2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure aPotential for catheter disconnection from the patient line stopcock connectors.
- Class II
Medical Device Recall · January 22, 2024
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administratioKits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
- Class II
Medical Device Recall · January 22, 2024
Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOWInvacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components
- Class II
Medical Device Recall · January 22, 2024
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administration of an analgesic or anesthetic agent to the epiKits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
- Class II
Medical Device Recall · January 22, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System (New and Refurbished)Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
- Class II
Medical Device Recall · January 22, 2024
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HPotential interference with the anti-fall system.
- Class II
Medical Device Recall · January 22, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS XT7600 Integrated SystemPotential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
- Class II
Medical Device Recall · January 22, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System (New and Refurbished)Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
- Class II
Medical Device Recall · January 19, 2024
INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Class II
Medical Device Recall · January 19, 2024
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Class III
Medical Device Recall · January 19, 2024
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliancesCustomers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
- Class III
Medical Device Recall · January 19, 2024
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliancesCustomers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
- Class II
Medical Device Recall · January 19, 2024
Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Class III
Medical Device Recall · January 19, 2024
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliancesCustomers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
- Class II
Medical Device Recall · January 19, 2024
Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Class II
Medical Device Recall · January 19, 2024
Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.