Open, ClassifiedPosted Sep 27, 2024·Initiated Aug 21, 2024
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Reason: Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Root cause: Device Design
Recalling firm: Percussionaire CorporationType: Set, Tubing And Support, Ventilator (W Harness)Distribution: US: Nationwide
OUS: Israel Japan Russia Switzerland Canada TurkeyRecall #Z-3208-2024
Open, ClassifiedPosted Sep 27, 2024·Initiated Aug 22, 2024
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 change of the pad and comparing with the corresponding blocks on a color chart.
The Healgen Series Reagent Strips for Urinalysis provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in Urine.
Reason: 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.
Root cause: Nonconforming Material/Component
Recalling firm: Healgen Scientific LlcType: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)Distribution: U.S. Nationwide distribution in the states of CA, GA and TX.Recall #Z-3303-2024
Open, ClassifiedPosted Sep 27, 2024·Initiated Aug 21, 2024
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Reason: 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.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: System, Test, Thyroid AutoantibodyDistribution: Worldwide distribution - US Nationwide.Recall #Z-3304-2024 Open, ClassifiedPosted Sep 27, 2024·Initiated Aug 21, 2024
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Reason: 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.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: System, Test, Thyroid AutoantibodyDistribution: Worldwide distribution - US Nationwide.Recall #Z-3305-2024 Open, ClassifiedPosted Sep 27, 2024·Initiated Jun 26, 2024
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
Reason: The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Root cause: Unknown/Undetermined by firm
Recalling firm: FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTDType: Over-The-Counter Covid-19 Antigen TestDistribution: International distribution to the countries of China and Hong Kong.Recall #Z-3306-2024
Open, ClassifiedPosted Sep 27, 2024·Initiated Jun 26, 2024
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
Reason: The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Root cause: Unknown/Undetermined by firm
Recalling firm: FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTDType: Over-The-Counter Covid-19 Antigen TestDistribution: International distribution to the countries of China and Hong Kong.Recall #Z-3307-2024
Open, ClassifiedPosted Sep 27, 2024·Initiated Jun 26, 2024
DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
Reason: The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Root cause: Unknown/Undetermined by firm
Recalling firm: FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTDType: Over-The-Counter Covid-19 Antigen TestDistribution: International distribution to the countries of China and Hong Kong.Recall #Z-3308-2024
Open, ClassifiedPosted Sep 27, 2024·Initiated Aug 29, 2024
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Reason: Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
Root cause: Under Investigation by firm
Recalling firm: Tornier, IncType: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedDistribution: US Nationwide distribution.Recall #Z-3309-2024
Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 30, 2024
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Reason: The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
Root cause: Software design
Recalling firm: Fresenius Kabi USA, LLCType: Pump, InfusionDistribution: US Nationwide.Recall #Z-3153-2024
Open, ClassifiedPosted Sep 26, 2024·Initiated Jul 24, 2024
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.
Reason: Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
Root cause: Mixed-up of materials/components
Recalling firm: TMJ Solutions IncType: Joint, Temporomandibular, ImplantDistribution: US Nationwide distribution in the state of MN.Recall #Z-3264-2024
Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516210
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3265-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516220
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3266-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516230
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3267-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516240
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3268-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516250
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3269-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516260
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3270-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516270
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3271-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516300
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3272-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516310
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3273-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516320
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3274-2024