The Recall Desk

Archive

May 2018 recalls

1,113 recalls were announced in May 2018.

What the numbers show

Critical
47
Severe
301
High
429
Moderate
304
Low
32

Of the 1,113 recalls this month scored against our rubric, 4% are Critical, 27% are Severe.

301–400 of 1113

  • SevereFDA (Food)·F-1433-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Products Due to Salmonella Contamination Risk

    Triangle Pharmanaturals LLC is recalling Lifted Kratom Gold Bali products because they may be contaminated with Salmonella.

    Product
    Lifted Kratom Gold Bali in 45 gram powder, 150 capsule and 300 capsule plastic bottles. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Food)·F-1401-2018·2018-05-16

    FDA Recalls Energique Herbal Supplements for Unapproved Drug Claims

    Grato Holdings is recalling Energique herbal supplements because they are marketed as unapproved new drugs based on disease claims.

    Product
    Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1436-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Capsules Due to Salmonella Risk

    Triangle Pharmanaturals LLC is recalling Third Eye Kratom White capsules because all Kratom products from the company may be contaminated with Salmonella.

    Product
    Third Eye Kratom White in 300 capsule plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Food)·F-1468-2018·2018-05-16

    Greenbelt Microgreens Recalled for Potential Listeria Contamination

    Greenbelt Greenhouse Ltd is recalling Fresh Microgreen Mix due to potential Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.

    Product
    Fresh Microgreen Mix, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00041 4
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1730-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope is recalling 18 custom tubing kits because a seal defect may cause the Better Bladder balloon to collapse, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0731-2018·2018-05-16

    Vitalab Pharmacy Recalls Sterile Injectable Due to Sterility Concerns

    Vitalab Pharmacy, Inc. is recalling a sterile injectable drug product because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1559-2018·2018-05-16

    Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 8,124 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1472-2018·2018-05-16

    Greenbelt Sunflower Microgreens Recalled for Listeria Contamination Risk

    Greenbelt Greenhouse Ltd is recalling Sunflower Microgreens due to potential Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.

    Product
    Sunflower Microgreens, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00030 8
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1572-2018·2018-05-16

    Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 720 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1733-2018·2018-05-16

    Datascope recalls custom pediatric ECMO tubing kits due to seal defect

    Datascope is recalling two custom pediatric ECMO tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow.

    Product
    BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1711-2018·2018-05-16

    Datascope Better Bladder Device Recalled Due to Seal Separation Risk

    Datascope is recalling Better Bladder devices in custom tubing kits because seal separation may cause balloon collapse and reduced ECMO blood flow.

    Product
    BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1723-2018·2018-05-16

    Datascope Recalls Better Bladder Custom Tubing Kits Due to Seal Separation

    Datascope Corporation is recalling 10 units of the BEQ-T 25501 Better Bladder Pack, Custom Tubing Kit. A seal defect may allow air entry, causing balloon collapse and reduced blood flow in ECMO circuits.

    Product
    BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0801-2018·2018-05-16

    Coast Quality Pharmacy Recalls MAA Kits Due to Sterility Concerns

    Coast Quality Pharmacy LLC is recalling 52 vials of Macroaggregated albumin (MAA) kits due to a lack of assurance of sterility. The affected products were distributed to six states.

    Product
    Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1575-2018·2018-05-16

    Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 270 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1623-2018·2018-05-16

    Boston Scientific Recalls Posterior LITE Sutures Due to Breakage Risk

    Boston Scientific Corporation is recalling 1,541 units of the Posterior LITE w/ Capio SLIM device because the sutures may break or detach.

    Product
    Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1390-2018·2018-05-16

    Superior Foods Recalls Smoked Salmon Spread Due to Listeria Risk

    Superior Foods Company is voluntarily recalling specific lots of Smoked Salmon Spread produced on March 26, 2018, due to potential contamination with Listeria monocytogenes.

    Product
    Smoked Salmon Spread 5 lb. bulk units; Simply Superior Smoked Salmon Spread 5 oz units; and Morey s Smoked Salmon Spread 6 oz units; Deli Cups, Deli Tubs
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1558-2018·2018-05-16

    Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 42 AirLife Pediatric Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1469-2018·2018-05-16

    Greenbelt Microgreens Recalled for Potential Listeria Contamination

    Greenbelt Greenhouse Ltd is recalling Sweet & Crunchy Microgreen Mix due to potential Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.

    Product
    Sweet & Crunchy Microgreen Mix, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00006 3
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0792-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Bendeka Due to Lack of Processing Controls

    Kroger Specialty Pharmacy is recalling Bendeka 25 mg/mL 4 mL MDVPF due to a lack of processing controls. The affected product was dispensed in five states between December 2017 and February 2018.

    Product
    Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1699-2018·2018-05-16

    Siemens Recalls Syngo.plaza Software to Prevent Patient Misdiagnosis

    Siemens Medical Solutions is recalling Syngo.plaza software due to format errors in study dates and issues with legacy presentation states that could lead to patient misdiagnosis.

    Product
    Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1728-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope Corporation is recalling BEQ-TOP 22301 Custom Tubing Kits because seal separation may allow air to enter the housing, causing the balloon to collapse and reducing blood flow.

    Product
    BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0732-2018·2018-05-16

    Vitalab Pharmacy Recalls Sterile Injectable Drugs Due to Sterility Concerns

    Vitalab Pharmacy is recalling specific lots of sterile injectable drugs because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-1465-2018·2018-05-16

    Badger Botanicals Recalls Kratom Products Due to Potential Salmonella

    Badger Botanicals LLC is recalling specific Kratom products due to potential Salmonella contamination. The recall covers products manufactured between January 1, 2018, and April 12, 2018.

    Product
    Acadica Kratom: Green Hulu 2 Kratom, 250g bags
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1555-2018·2018-05-16

    Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 24 AirLife Pediatric Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1706-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling specific custom tubing kits because the Better Bladder device may allow air to enter, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0754-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Azithromycin Tablets Due to Processing Controls

    Kroger Specialty Pharmacy is recalling Azithromycin 250 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.

    Product
    Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1731-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling 11 custom tubing kits containing the Better Bladder device due to a seal defect that may cause balloon collapse and reduced blood flow.

    Product
    BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0729-2018·2018-05-16

    Vitalab Alprostadil Injectable Recalled for Sterility Assurance Concerns

    Vitalab Pharmacy is recalling Alprostadil 20 mcg/mL injectable vials because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1739-2018·2018-05-16

    Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues

    Zimmer Biomet is recalling 107 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.

    Product
    Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1712-2018·2018-05-16

    Datascope Better Bladder Device Recalled Due to Seal Separation Risk

    Datascope Corporation is recalling the Better Bladder device found in custom tubing kits. A seal defect may allow air entry, causing balloon collapse and reduced blood flow in ECMO circuits.

    Product
    BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
    Category
    Medical Device
    Distribution
    13 states
  • SevereNHTSA·18V318000·2018-05-16

    Porsche Recalls 2018 Macan Models Due to Control Unit Failure Risk

    Porsche is recalling 2018 Macan and Macan S vehicles because a control unit may fail, potentially impairing safety functions and drivability.

    Product
    PORSCHE — PORSCHE MACAN, MACAN S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1721-2018·2018-05-16

    Datascope Custom Tubing Kit Recall Due to Seal Separation

    Datascope is recalling 9 custom tubing kits because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing blood flow.

    Product
    BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1560-2018·2018-05-16

    Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 4,640 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1715-2018·2018-05-16

    Datascope recalls Better Bladder device due to seal separation risk

    Datascope is recalling the Better Bladder device because seal separation may cause balloon collapse and reduced blood flow in ECMO circuits.

    Product
    BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1563-2018·2018-05-16

    Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 2,340 AirLife Pediatric Resuscitation Devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1562-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 8,100 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0730-2018·2018-05-16

    Vitalab Pharmacy Recalls Sterile Injectable Drug Due to Sterility Concerns

    Vitalab Pharmacy is recalling 22 vials of a sterile injectable drug because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1725-2018·2018-05-16

    Datascope recalls NICU ECC Pack custom tubing kits due to seal defect

    Datascope is recalling specific NICU ECC Pack custom tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow in ECMO circuits.

    Product
    NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1720-2018·2018-05-16

    Datascope Recalls Custom Neonatal ECC Tubing Kits Due to Seal Defect

    Datascope is recalling seven custom neonatal ECMO tubing kits because a seal defect may allow air entry, potentially causing a drop in blood flow.

    Product
    BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1666-2018·2018-05-16

    Baxter Infusion Pump Recalled for Improper Testing Documentation

    Baxter Healthcare Corporation is recalling 444 Sigma Spectrum Infusion Pumps because service technicians omitted required release tests, which could lead to serious adverse health consequences.

    Product
    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1467-2018·2018-05-16

    Greenbelt Broccoli Microgreens Recalled for Potential Listeria Contamination

    Greenbelt Greenhouse Ltd is recalling 498 packages of Broccoli Microgreens due to potential Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.

    Product
    Broccoli Microgreens, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00016 2
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1574-2018·2018-05-16

    Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 498 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1413-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Capsules Due to Salmonella Risk

    Triangle Pharmanaturals LLC is recalling Raw Form Organics Maeng Da Kratom Emerald Green capsules because they may be contaminated with Salmonella.

    Product
    Raw Form Organics Maeng Da Kratom Emerald Green; 150 capsule and 300 capsule plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Food)·F-1416-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Products Due to Salmonella Contamination

    Triangle Pharmanaturals LLC is recalling Raw Form Organics Maeng Da Kratom Amethyst Gold capsules due to potential Salmonella contamination.

    Product
    Raw Form Organics Maeng Da Kratom Amethyst Gold in 150 capsule and 300 capsule plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Devices)·Z-1552-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 305,136 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0791-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Capecitabine Tablets Due to Processing Controls

    Kroger Specialty Pharmacy is recalling Capecitabine 500 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.

    Product
    Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1482-2018·2018-05-16

    Draeger Fabius GS Premium Anesthesia Machines Recalled for Ventilation Failure Risk

    Draeger Medical is recalling 27 Fabius GS Premium anesthesia machines because automatic ventilation may fail if motor position detection is disturbed.

    Product
    Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1722-2018·2018-05-16

    Datascope Better Bladder Custom Tubing Kit Recalled for Seal Separation

    Datascope Corporation is recalling Better Bladder custom tubing kits because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing ECMO blood flow.

    Product
    BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1579-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Replacement Kits Due to Mask Sticking

    Vyaire Medical is recalling 150 AirLife Resuscitation replacement kits because the mask component may stick to the elbow, preventing disconnection.

    Product
    AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1440-2018·2018-05-16

    Stonewall Kitchen Basil Pesto Aioli Recalled for Undeclared Eggs

    Stonewall Kitchen is recalling Basil Pesto Aioli because the product may contain undeclared eggs. The recall affects 732 units distributed in 20 states.

    Product
    STONEWALL KITCHEN Basil Pesto Aioli Net Weight Net 10.25 oz. UPC: 7 11381 03060 8. Product is incorrectly labeled as Basil Pesto, Net Weight 8 oz.
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Devices)·Z-1577-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking Issue

    Vyaire Medical is recalling 797 AirLife Resuscitation Broselow Hinkle Kits because the mask may stick to the elbow, preventing disconnection.

    Product
    AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1726-2018·2018-05-16

    Datascope Recalls BEQ-TOP 24500 Adult ECC Custom Tubing Kits

    Datascope is recalling four BEQ-TOP 24500 Adult ECC Custom Tubing Kits because a seal defect may allow air to enter the housing, potentially collapsing the balloon and reducing blood flow.

    Product
    BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1564-2018·2018-05-16

    Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 2,262 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1729-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope Corporation is recalling specific custom tubing kits because a seal defect may cause the balloon to collapse, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Food)·F-1399-2018·2018-05-16

    Ziegenfelder Cherry-Pineapple Pops Recalled for Listeria Contamination

    Ziegenfelder Company is recalling Budget $aver Monster Cherry-Pineapple Pops after Listeria monocytogenes was found in the Denver plant environment.

    Product
    Budget $aver Monster Cherry-Pineapple Pops Net Contents 36 FL OZ
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Devices)·Z-1567-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 17,172 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1553-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 54 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1570-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 180 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1550-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 1,260 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1784-2018·2018-05-16

    TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances

    TP Orthodontics is recalling 10 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.

    Product
    Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Food)·F-1466-2018·2018-05-16

    Greenbelt Arugula Microgreens Recalled for Listeria Contamination Risk

    Greenbelt Greenhouse Ltd is recalling Arugula Microgreens due to a potential for Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.

    Product
    Arugula Microgreens, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00012 4
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1573-2018·2018-05-16

    Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 900 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1569-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 2,982 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0795-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Perjeta Vials Due to Processing Controls

    Kroger Specialty Pharmacy is recalling Perjeta 420 mg/14 mL vials due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.

    Product
    Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1724-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling 18 custom tubing kits because a seal defect may allow air to enter the device, potentially causing a drop in ECMO blood flow.

    Product
    BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1717-2018·2018-05-16

    Datascope Recalls Better Bladder Devices in Custom Tubing Kits

    Datascope is recalling specific custom tubing kits because the Better Bladder device may fail, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1710-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling the Better Bladder device in custom tubing kits because seal separation may allow air to enter the housing, potentially causing a drop in ECMO circuit blood flow.

    Product
    BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752
    Category
    Medical Device
    Distribution
    13 states
  • SevereNHTSA·18V323000·2018-05-16

    BMW M5 Recall Engine Software Fuel Pump Stall Risk

    BMW of North America is recalling certain 2018 BMW M5 vehicles because engine control unit software may cause the fuel pump to stop, increasing crash risk.

    Product
    BMW — BMW M5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1400-2018·2018-05-16

    Peaceful Mountain Stomach Rescue Recalled as Unapproved New Drug

    Grato Holdings is recalling Peaceful Mountain Stomach Rescue dietary supplements because they are unapproved new drugs based on disease claims.

    Product
    Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1481-2018·2018-05-16

    Draeger Fabius MRI Anesthesia Machines Recalled for Ventilation Failure Risk

    Draeger Medical is recalling eight Fabius MRI anesthesia machines because automatic or manual ventilation may fail if the motor position is disturbed or the ventilator cover is damaged.

    Product
    Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1565-2018·2018-05-16

    Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 1,800 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1625-2018·2018-05-16

    Boston Scientific Recalls Pinnacle Posterior PFR Kits Due to Suture Breakage Risk

    Boston Scientific is recalling 24 units of Pinnacle Posterior PFR Kits because the Capio sutures may break or detach.

    Product
    PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1408-2018·2018-05-16

    Eastland Food Recalls Tamarind Candy Due to Elevated Lead Levels

    Eastland Food Corporation is recalling Asian Best Tamarind Candy due to lead levels exceeding FDA action limits.

    Product
    Asian Best, Tamarind Candy Hot Flavor Net Weight: 4 oz. Units Per Carton: 72 units
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1571-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 4,500 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0866-2018·2018-05-16

    AuroMedics Recalls Ampicillin and Sulbactam Injection Due to Particulate Matter

    AuroMedics Pharma LLC is recalling 54,720 vials of Ampicillin and Sulbactam for Injection due to confirmed reports of visible red rubber particles.

    Product
    AMPICILLIN AND SULBACTAM — AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0728-2018·2018-05-16

    Vitalab Methylcobalamin Injection Recalled Due to Sterility Concerns

    Vitalab Pharmacy is recalling 178 vials of Methylcobalamin for injection because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1547-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 5,400 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1551-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 30 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1471-2018·2018-05-16

    Greenbelt Pea Shoots Microgreens Recalled for Listeria Contamination Risk

    Greenbelt Greenhouse Ltd is recalling 546 packages of Pea Shoots Microgreens due to potential Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.

    Product
    Pea Shoots Microgreens, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00023 0
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1557-2018·2018-05-16

    Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 24 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1709-2018·2018-05-16

    Datascope recalls BEQ-TOP 5210 ECC Set custom tubing kits

    Datascope is recalling 18 custom tubing kits because a seal defect may cause balloon collapse, increasing resistance to flow in the venous line.

    Product
    BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1719-2018·2018-05-16

    Datascope recalls custom tubing kits with potential Better Bladder seal defect

    Datascope is recalling nine custom tubing kits because a seal defect in the Better Bladder device may allow air entry, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1576-2018·2018-05-16

    Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 1,140 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1429-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Capsules Due to Salmonella Risk

    Triangle Pharmanaturals LLC is recalling Naturally Kratom Bali Gold capsules because all Kratom products from the company may be contaminated with Salmonella.

    Product
    Naturally Kratom Bali Gold in 6 capsule bags. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-1753-2018·2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage or Air Aspiration

    Cook Inc. is recalling 886 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1621-2018·2018-05-16

    Boston Scientific Recalls Capio RP Sutures Due to Breakage Risk

    Boston Scientific is recalling 2,567 units of Capio RP sutures because they may break or detach during surgery.

    Product
    Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0784-2018·2018-05-16

    Kroger Recalls Sprycel Tablets Due to Lack of Processing Controls

    Kroger Specialty Pharmacy is recalling Sprycel 100 mg tablets because of a lack of processing controls. The affected product was distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.

    Product
    Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply
    Category
    Drug
    Distribution
    5 states
  • HighFDA (Devices)·Z-1619-2018·2018-05-16

    Boston Scientific Recalls Capio Open Access Box 4 Sutures

    Boston Scientific is recalling 21,051 units of Capio Open Access Box 4 sutures due to a potential for the sutures to break or detach during use.

    Product
    Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1636-2018·2018-05-16

    Vygon Maximum Barrier Insertion Tray Recalled for Potential Sterility Compromise

    Vygon U.S.A. is recalling Maximum Barrier Insertion Trays because potential friction holes may affect the product's sterility.

    Product
    Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2018·2018-05-16

    Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues

    Zimmer Biomet is recalling specific lots of Gentle Threads Interference Screws because they were overexposed to ethylene oxide sterilization, which may compromise the sterile barrier.

    Product
    Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2018·2018-05-16

    Microline Surgical Recalls ReNew Dolphin Nose Disposable Dissector Tips

    Microline Surgical is recalling specific lots of ReNew Dolphin Nose Disposable Dissector Tips due to a potentially compromised sterile barrier.

    Product
    ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1781-2018·2018-05-16

    Ninepoint Medical Recalls NvisionVLE Low-Profile Optical Probes

    Ninepoint Medical is recalling 152 NvisionVLE Low-Profile Optical Probes because the distal tips may detach from the probe shaft during use.

    Product
    NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1389-2018·2018-05-16

    Bob's Red Mill Whole Wheat Bread Mix Recalled for Undeclared Wheat

    Bob's Red Mill is recalling 100% Whole Wheat Bread Mix because the label fails to declare wheat, a major allergen.

    Product
    Bob's Red Mill 100% Whole Wheat Bread Mix, Item 1674C194, packaged in flexible packaging bag, 4 bags to a cardboard case, each bag weighs 19 oz. The UPC is 0 39978 00667 7. The label on the FRONT side of a package is read in parts: "***Bob's Red Mill ***100% WHOLE WHEAT…
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1661-2018·2018-05-16

    Siemens Tacrolimus Assay Recalled for Interference with Sulfasalazine and Sulfapyridine

    Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Tacrolimus Assay because it may produce inaccurate results when patients take sulfasalazine or sulfapyridine.

    Product
    Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states

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