The Recall Desk

Archive

August 2016 recalls

766 recalls were announced in August 2016.

What the numbers show

Critical
77
Severe
169
High
248
Moderate
235
Low
37

Of the 766 recalls this month scored against our rubric, 10% are Critical, 22% are Severe.

Which agencies issued them

201–300 of 766

  • HighFDA (Devices)·Z-2574-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 63,320 units distributed worldwide.

    Product
    Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction vi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2016·2016-08-24

    Straumann Bone Level Implant Recalled for Misalignment with Transfer Piece

    Straumann Manufacturing, Inc. is recalling 33 Bone Level Implants due to misalignment with the Loxim transfer piece markings, which may result in incorrect implant positioning.

    Product
    Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2566-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the package may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2526-2016·2016-08-24

    Ab Sciex API 3200MD Software Recall for Incorrect Quantitative Results

    Ab Sciex is recalling MultiQuant MD software for API 3200MD systems due to potential incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compoun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2584-2016·2016-08-24

    Synthes Titanium Single Vector Distractor Body Recalled for Fastener Separation

    Synthes (USA) Products LLC is voluntarily recalling Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.

    Product
    TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2551-2016·2016-08-24

    Merge Unity Z3D Software Recalled for Calcium Score Inaccuracy

    Merge Healthcare is recalling Merge Unity Z3D software because it cannot accurately determine calcium scores for scans with slice thicknesses other than 3 mm.

    Product
    Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging sys
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2569-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall covers units distributed worldwide.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a sin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i is recalling 1,648,273 dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2587-2016·2016-08-24

    Nidek Optical Biometer AL-Scan Recalled for Inaccurate Axial Length Measurements

    Nidek Inc. is recalling 17 Optical Biometer AL-Scan devices because they measured axial lengths as much shorter than actual values.

    Product
    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature rad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2592-2016·2016-08-24

    Avid Medical Recalls Unlabeled Latex-Containing Telfa Dressing Kits

    Avid Medical is recalling 200 custom procedure trays that included latex-containing Telfa dressings without latex warnings. The products were distributed to Virginia and Massachusetts.

    Product
    MAMMOGRAPHY
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1916-2016·2016-08-24

    Kerry Inc. Recalls Jalapeño Breader Due to E. coli O121 Contamination Risk

    Kerry Inc. is recalling Golden Dipt Jalapeño Breader because it was made with flour potentially contaminated with E. coli O121.

    Product
    Golden Dipt¿ Jalape¿o Breader is in a white 10 pound bag with the UPC number 763089721548 and Item Number: G5620.690.
    Category
    Food
    Distribution
    9 states
  • HighNHTSA·16V618000·2016-08-24

    Ford Recalls 2015-2016 Transit Vehicles Due to Fuel System Clog Risk

    Ford is recalling 2015-2016 Transit vehicles with 3.2L diesel engines because metallic debris may clog the fuel system, potentially causing the engine to stall and increasing crash risk.

    Product
    FORD — FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1937-2016·2016-08-24

    Haitai Matdongsan Peanuts Crunch Snack Recalled for Unlabeled Soy

    H & E Trading Inc is recalling Haitai Matdongsan Peanuts Crunch Snack because it contains soy lecithin that was not listed on the label.

    Product
    Haitai Matdongsan Peanuts Crunch Snack, Net Wt. 11.49 oz. (325gr), Imported and Distributed by: Haitai, Inc, 7227 Telegraph Road, Montebello, CA 90640 - H & E Trading Inc, 514 Eugene Way, Wyckoff, NJ 07481, UPC 8 801019606786
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2542-2016·2016-08-24

    Toshiba Recalls Xario Ultrasound Systems Due to Overheating Software Error

    Toshiba American Medical Systems is recalling 93 Xario 100 and 200 Diagnostic Ultrasound Systems because a software error may cause the devices to become hot.

    Product
    Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2558-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Argon Modified Flat l Electrodes due to a potential sterile barrier breach.

    Product
    Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2577-2016·2016-08-24

    Medtronic Recalls Laparoscopic Electrode Due to Sterile Barrier Compromise Risk

    Medtronic is recalling 3,470 Valleylab Laparoscopic Flat L-Hook Electrodes because the package may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2540-2016·2016-08-24

    TYRX Absorbable Antibacterial Envelope Recalled for Unvalidated Manufacturing Processes

    TYRX Inc. is recalling 2,993 units of the TRYX Absorbable Antibacterial Envelope because key manufacturing processes were not adequately validated.

    Product
    TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2552-2016·2016-08-24

    Reshape Medical Recalls ReShape Integrated Dual Balloon System Due to Assembly Error

    Reshape Medical Inc. is recalling 56 units of the ReShape Integrated Dual Balloon System because a manufacturing assembly error may cause saline leakage during inflation.

    Product
    ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2541-2016·2016-08-24

    TYRX Neuro Absorbable Antibacterial Envelope Recalled for Manufacturing Validation Issues

    TYRX Inc. is recalling 194 units of the TRYX Neuro Absorbable Antibacterial Envelope because manufacturing processes were not adequately validated.

    Product
    TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2546-2016·2016-08-24

    Medtronic EnVeo Delivery Catheter System Recalled for Vascular Trauma Risk

    Medtronic is recalling 7,319 EnVeo Delivery Catheter Systems worldwide due to a potential for vascular trauma during use.

    Product
    Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2556-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item Code: E25306 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2016·2016-08-24

    Biomet 3i Recalls Drill Stop Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Drill Stop Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Drill Stop Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2570-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall covers lots 209358X through 60870083X distributed worldwide.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code: E2781R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2572-2016·2016-08-24

    Medtronic Recalls Laparoscopic Electrodes Due to Sterile Barrier Compromise

    Medtronic is recalling 1,440 Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E2782R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and sucti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2583-2016·2016-08-24

    Synthes Recalls Titanium Single Vector Distractor Bodies Due to Fastener Separation Risk

    Synthes (USA) Products LLC is voluntarily recalling 413 Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.

    Product
    TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2585-2016·2016-08-24

    Synthes Recalls Titanium Single Vector Distractor Proximal Foot Plates

    Synthes is voluntarily recalling Titanium Single Vector Distractor Proximal Foot Plates because the fastener may separate prematurely from the plate.

    Product
    TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular defici
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2016·2016-08-24

    Biomet 3i Recalls Twist Lock Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Twist Lock Coping Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16249·2016-08-24

    Safety 1st Step and Go Travel Systems Recalled for Fall Hazard

    Dorel Juvenile is recalling Safety 1st Step and Go Travel Systems because the stroller tray can disengage, posing a fall hazard to infants.

    Product
    Safety 1st Step and Go Travel Systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2582-2016·2016-08-24

    Synthes Recalls Titanium Single Vector Distractor Bodies Due to Fastener Separation Risk

    Synthes (USA) Products LLC is voluntarily recalling 182 units of Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.

    Product
    TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2016·2016-08-24

    Ab Sciex Mass Spectrometer Software Recall for Incorrect Quantitative Results

    Ab Sciex is recalling MultiQuant MD software for Triple Quad 4500MD systems because it may display incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031257 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in hum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2539-2016·2016-08-24

    TYRX Antibacterial Envelope Recalled for Unvalidated Manufacturing Processes

    TYRX Inc. is recalling 3,460 units of TRYX Antibacterial Envelopes because manufacturing processes were not adequately validated.

    Product
    TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2548-2016·2016-08-24

    Cepheid Recalls Xpert MRSA Diagnostic Kits Due to Performance Issues

    Cepheid is recalling specific lots of Xpert MRSA diagnostic kits because internal investigations found potential performance issues at lower positive sample concentrations.

    Product
    Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swab
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-2529-2016·2016-08-24

    Ab Sciex QTRAP 4500MD Mass Spectrometer Software Recall for Incorrect Results

    Ab Sciex is recalling 28 QTRAP 4500MD mass spectrometers because MultiQuant MD software may display incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human spe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1923-2016·2016-08-24

    Coconut milk recalled for thermal under-processing

    Procesadora de Frutos y Vegetales del Caribe is voluntarily recalling specific lots of 13.5 oz canned coconut milk because the product was thermally under-processed.

    Product
    Coconut milk , 13.5 fld oz, can, 214x406 3 pieces steel tins ,24 tins per case. Refrigerate after opening.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2586-2016·2016-08-24

    Synthes Titanium Single Vector Distractor Recalled for Fastener Separation Risk

    Synthes is recalling Titanium Single Vector Distractor Proximal Foot/Left devices because a fastener may separate prematurely from the plate.

    Product
    TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2581-2016·2016-08-24

    Synthes Recalls Titanium Single Vector Distractor Bodies Due to Fastener Separation Risk

    Synthes (USA) Products LLC is voluntarily recalling 90 units of Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.

    Product
    TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2553-2016·2016-08-24

    Stanmore METS SMILES Total Knee Replacement Recall for Fit Issues

    Stanmore Implants Worldwide Ltd. is recalling 3 units of METS SMILES Total Knee Replacements because the femoral plateau plates may not fit the intended mating component.

    Product
    METS SMILES Total Knee Replacement
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2563-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrodes Recalled for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall affects 6,381 units distributed worldwide.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a sing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2472-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Implant Twist Lock TM Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Implant Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2500-2016·2016-08-24

    Biomet 3i Recalls Titanium Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling 1,648,273 titanium dental implants because pouches may not have been sealed during packing.

    Product
    Certain Titanium Large Hexed Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2408-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling specific dental implant abutments because their packaging pouches may not have been sealed during packing.

    Product
    Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) Item: IWTH564 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2495-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Standard Abutment Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Standard Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2422-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 LDA Screw SBL 3mm(D) dental implants because pouches may not have been sealed during packing.

    Product
    LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2504-2016·2016-08-24

    Biomet 3i Recalls Conical 17 Degree Angled Abutment Dental Implants

    Biomet 3i, LLC is recalling Conical 17 degree Angled Abutment dental implants because pouches may not have been sealed during packing.

    Product
    Conical 17 degree Angled Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2474-2016·2016-08-24

    Biomet 3i Recalls Dental Implant Abutments Due to Sealing Defects

    Biomet 3i is recalling IOL Abutment and Screw dental implants because pouches may not have been sealed during packing.

    Product
    IOL Abutment and Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2449-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling 1.6 million Temporary Non-Hexed Cylinder Dental Implants because pouches may not have been sealed during packing.

    Product
    Temporary Non-Hexed Cylinder Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2544-2016·2016-08-24

    LeMaitre Vascular Recalls 1.5 mm HYDRO Valvulotome Due to Wire Detachment

    LeMaitre Vascular is recalling 380 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach, rendering the device inoperable.

    Product
    1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2477-2016·2016-08-24

    Biomet 3i Recalls IOL Pick-Up Impression Coping Due to Sealing Issues

    Biomet 3i is recalling IOL Pick-Up Impression Coping dental implant devices because pouches may not have been sealed during packing.

    Product
    IOL Pick-Up Impression Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2456-2016·2016-08-24

    Biomet 3i Recalls Conical Healing Caps Due to Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 Conical Healing Caps for dental implants because pouches may not have been sealed during packing.

    Product
    Conical Healing Cap Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2424-2016·2016-08-24

    Biomet 3i Recalls Dental Implant O-Ring Abutments Due to Sealing Defect

    Biomet 3i is recalling O-Ring Abutments for dental implants because pouches may not have been sealed during packing.

    Product
    O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2545-2016·2016-08-24

    LeMaitre Vascular Recalls 1.5 mm HYDRO LeMaitre Valvulotome Devices

    LeMaitre Vascular is recalling 50 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach, rendering the device inoperable.

    Product
    1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2441-2016·2016-08-24

    Biomet 3i Dental Implants Recalled for Unsealed Pouches

    Biomet 3i is recalling 1.6 million dental implant protection caps because pouches may not have been sealed during packing.

    Product
    Provide Protection Cap Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2481-2016·2016-08-24

    Biomet 3i Recalls Locator Abutment Impression Coping Dental Implants

    Biomet 3i, LLC is recalling Locator Abutment Impression Coping dental implants because pouches may not have been sealed during packing.

    Product
    Locator Abutment Impression Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2427-2016·2016-08-24

    Biomet 3i Recalls Locator Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Locator Extended Range Males dental implants because pouches may not have been sealed during packing.

    Product
    Locator Extended Range Males 4pk Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2508-2016·2016-08-24

    Biomet 3i Recalls Conical Abutment Pick-up Coping Dental Implants

    Biomet 3i, LLC is recalling Conical Abutment Pick-up Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Conical Abutment Pick-up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2448-2016·2016-08-24

    Biomet 3i Recalls Temporary Hexed Cylinder Dental Implants

    Biomet 3i, LLC is recalling Temporary Hexed Cylinder Dental implants because pouches may not have been sealed during packing.

    Product
    Temporary Hexed Cylinder Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2428-2016·2016-08-24

    Biomet 3i Recalls Locator Extra Light Angled Dental Implant Components

    Biomet 3i is recalling Locator Extra Light Angled Replacement Males because pouches may not have been sealed during packing.

    Product
    Locator Extra Light Angled Replacement Males 4pk Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2432-2016·2016-08-24

    Biomet 3i Recalls Locator Replacement Housing Kits Due to Sealing Defects

    Biomet 3i is recalling Locator Replacement Housing Kits because pouches may not have been sealed during packing. The recall affects 1,648,273 units distributed worldwide.

    Product
    Locator Replacement Housing Kit Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2490-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Pick-up Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Pick-up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2576-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling 332 Valleylab Laparoscopic Flat L-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1457-2016·2016-08-24

    Actavis Recalls Glipizide 2.5 mg Extended-Release Tablets for Dissolution Failure

    Actavis Inc is recalling specific lots of Glipizide 2.5 mg Extended-Release tablets because they failed to meet dissolution specifications.

    Product
    Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2502-2016·2016-08-24

    Biomet 3i Recalls Twist Lock Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Twist Lock Straight Transfer Coping Dental Implants because pouches may not have been sealed during packing.

    Product
    Certain Twist Lock TM Straight Transfer Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2559-2016·2016-08-24

    Medtronic Recalls Laparoscopic Argon Sharp Needle Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling 210 units of Valleylab Laparoscopic Argon Sharp Needle Electrodes due to a potential sterile barrier breach.

    Product
    Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM Item Code: E258228 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2530-2016·2016-08-24

    Danville Materials Recalls Perioscopy Sheaths Due to Unsupported Shelf-Life Labeling

    Danville Materials is recalling Perioscopy Sheaths because validation data to support the 3-year shelf-life claim on the label is unavailable.

    Product
    Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details o
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2440-2016·2016-08-24

    Biomet 3i Recalls Dental Implant Impression Copings Due to Sealing Issues

    Biomet 3i, LLC is recalling 1,648,273 Provide Impression Coping dental implant devices because pouches may not have been sealed during packing.

    Product
    Provide Impression Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2469-2016·2016-08-24

    Biomet 3i Recalls Dental Implant Cover Screws Due to Sealing Issues

    Biomet 3i, LLC is recalling 1,648,273 dental implant cover screws because pouches may not have been sealed during packing.

    Product
    Implant Cover Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1461-2016·2016-08-24

    Zydus Recalls Venlafaxine Hydrochloride Capsules for Dissolution Failures

    Zydus Pharmaceuticals USA Inc. is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules because retained samples failed dissolution specifications.

    Product
    VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2489-2016·2016-08-24

    Biomet 3i Recalls Non-Hexed Dental Implants Due to Sealing Defects

    Biomet 3i is recalling approximately 1.6 million non-hexed dental implants because pouches may not have been sealed during packing.

    Product
    Certain Non-Hexed Implant Pick-up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2412-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Post Dental Implants Due to Sealing Issues

    Biomet 3i, LLC is recalling specific Gingihue Post dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2505-2016·2016-08-24

    Biomet 3i Recalls Conical 25 Degree Angled Abutments for Sealing Defects

    Biomet 3i, LLC is recalling Conical 25 degree Angled Abutment dental implants because pouches may not have been sealed during packing.

    Product
    Conical 25 degree Angled Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2521-2016·2016-08-24

    Biomet 3i Recalls Gingihue Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Gingihue 15-degree angled post dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue TM 15 degree Angled Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2507-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Conical Abutment Gold Standard ZR Dental implants because pouches may not have been sealed during packing.

    Product
    Conical Abutment Gold Standard ZR TM Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2518-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 EP Pick-Up Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Certain EP Pick-Up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2557-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Flexible Argon Blade Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item Code: E258028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2455-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Conical EP Twist Lock TM Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Conical EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2491-2016·2016-08-24

    Biomet 3i Recalls Preformance Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Preformance 15 degrees Pre-Angled Post Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Preformance 15 degrees Pre-Angled Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2409-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Dental Implants Due to Sealing Defects

    Biomet 3i is recalling specific Gingihue dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2452-2016·2016-08-24

    Biomet 3i Recalls Conical EP Healing Caps Due to Sealing Defects

    Biomet 3i, LLC is recalling Conical EP Healing Caps for dental implants because pouches may not have been sealed during packing.

    Product
    Conical EP Healing Cap Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2418-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling specific dental implant copings because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2413-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling specific Gingihue Post dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2016·2016-08-24

    Biomet 3i Recalls Straight Healing Abutments Due to Sealing Defects

    Biomet 3i is recalling specific dental implant abutments because pouches may not have been sealed during packing.

    Product
    Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2459-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling DAL-RO Housing, Female Assembly dental implants because pouches may not have been sealed during packing.

    Product
    DAL-RO Housing, Female Assembly Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2419-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling Gingihue 15 degrees Pre-Angled Post dental implants because pouches may not have been sealed during packing.

    Product
    Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2514-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 Conical 25 degree Angled Abutment Dental Implants because pouches may not have been sealed during packing.

    Product
    Certain Conical 25 degree Angled Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2426-2016·2016-08-24

    Biomet 3i Recalls Dental Implant O-Ring Abutments Due to Sealing Defect

    Biomet 3i is recalling specific lots of O-Ring Abutments for dental implants because pouches may not have been sealed during packing.

    Product
    O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide

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