The Recall Desk

Archive

May 2018 recalls

1,113 recalls were announced in May 2018.

What the numbers show

Critical
47
Severe
240
High
488
Moderate
304
Low
34

Of the 1,113 recalls this month scored against our rubric, 4% are Critical, 22% are Severe.

Which agencies issued them

301–400 of 1113

  • 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 moun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1461-2018·2018-05-16

    Maya Distribution Recalls Dragon Bali Kratom Powder and Capsules for Salmonella

    Maya Distribution, LLC is recalling Dragon Bali Kratom Powder and Capsules because samples collected by public health officials found the presence of Salmonella.

    Product
    Dragon Bali Kratom Powder: 60g Bottle. Dragon Bali Kratom Capsules in bottles:200 ct 500mg, 80 ct x 500, 40 ct x 500mg and 20 ct x 500 mg pouch.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-1431-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Products Due to Salmonella Contamination Risk

    Triangle Pharmanaturals LLC is recalling Lifted Kratom Red Maeng Da products due to potential Salmonella contamination. The recall covers powder and capsule bottles distributed across multiple states.

    Product
    Lifted Kratom Red Maeng Da 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 (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 in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0797-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Tasigna Capsules Due to Processing Controls

    Kroger Specialty Pharmacy is recalling Tasigna Capsules 150 mg due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.

    Product
    Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1716-2018·2018-05-16

    Datascope Recalls Custom Tubing Packs Due to Potential Seal Separation

    Datascope is recalling 22 units of BEQ-TOP 33700 ECC 3/8" PACK custom tubing kits because a seal defect may cause balloon collapse and reduced blood flow.

    Product
    BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
    Category
    Medical Device
    Distribution
    13 states
  • 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 (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-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 (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 (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-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 (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 (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 (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-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 dru
    Category
    Medical Device
    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-1414-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Capsules Due to Salmonella Risk

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

    Product
    Raw Form Organics Maeng Da Kratom Ivory White; 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-1435-2018·2018-05-16

    Triangle Pharmanaturals Recalls Kratom Capsules Due to Salmonella Risk

    Triangle Pharmanaturals LLC is recalling Live Well Kratom Red Maeng Da capsules in 150 and 300-count bottles due to potential Salmonella contamination.

    Product
    Live Well Kratom Red Maeng Da 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-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-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
  • 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-1707-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

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

    Product
    Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
    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-1713-2018·2018-05-16

    Datascope Recalls Better Bladder Device in Custom Tubing Kits

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

    Product
    BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1714-2018·2018-05-16

    Datascope recalls Better Bladder device due to seal separation risk

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

    Product
    BEQ-TOP 22701, Catalog No. 701050790
    Category
    Medical Device
    Distribution
    13 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-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-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-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-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-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 (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-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
  • SevereNHTSA·18V322000·2018-05-16

    McNeilus Recalls 2008-2018 Bridgemaster V Mixers Due to Tank Rupture Risk

    McNeilus is recalling 2008-2018 Bridgemaster V concrete mixers because a hydraulic tank may overpressurize and rupture, posing risks of injury and road hazards.

    Product
    MCNEILUS — MCNEILUS BRIDGEMASTER V MIXER
    Category
    Vehicle
    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
  • 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-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 (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 (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
  • 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
  • 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
  • HighFDA (Drugs)·D-0800-2018·2018-05-16

    Kroger Recalls Lupron Depot Due to Lack of Processing Controls

    Kroger Specialty Pharmacy is recalling Lupron Depot 22.5 mg 3 month Kits due to a lack of processing controls. The recall affects lots dispensed in MS, LA, AR, IL, and FL between December 2017 and February 2018.

    Product
    Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
    Category
    Drug
    Distribution
    5 states
  • HighFDA (Drugs)·D-0739-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Pulmicort Respules Due to Processing Controls

    Kroger Specialty Pharmacy is recalling Pulmicort Respules 0.5 mg/2mL due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.

    Product
    Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04
    Category
    Drug
    Distribution
    5 states
  • HighFDA (Devices)·Z-1672-2018·2018-05-16

    Siemens Recalls Dimension Vista MMB Reagent Cartridges Due to Biotin Interference

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridges because the instructions for use do not list the biotin concentration that causes interference.

    Product
    Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1667-2018·2018-05-16

    Baxter Sigma Spectrum Infusion Pump Recalled for Incomplete Testing Documentation

    Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because final release testing was improperly documented, omitting critical safety checks.

    Product
    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE 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 dru
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1749-2018·2018-05-16

    DePuy Mitek Recalls Latarjet EXPERIENCE Sharp Curved Ostetome

    DePuy Mitek is recalling 84 units of the Latarjet EXPERIENCE Sharp Curved Ostetome due to reports of the product loosening or coming unscrewed from the handle.

    Product
    LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1664-2018·2018-05-16

    Baxter Sigma Spectrum Infusion Pump Recall Due to Testing Documentation Errors

    Baxter is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted specific safety tests. The missing tests for air and occlusion detection could lead to serious health consequences.

    Product
    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL 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 drug
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0790-2018·2018-05-16

    Kroger Recalls Capecitabine Tablets Due to Lack of Processing Controls

    Kroger Specialty Pharmacy is recalling one lot of Capecitabine 150 mg tablets because the product lacks required processing controls. The recall affects units dispensed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.

    Product
    Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
    Category
    Drug
    Distribution
    5 states
  • 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 BREAD
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1756-2018·2018-05-16

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

    Cook Inc. is recalling 6,345 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, HPCT8.8-120-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 (Drugs)·D-0747-2018·2018-05-16

    Kroger Recalls Botox Due to Lack of Processing Controls

    Kroger Specialty Pharmacy is recalling Botox 100 Units Vials because of a lack of processing controls. The product was distributed in MS, LA, AR, IL, and FL.

    Product
    Botox 100 Units Vial NDC 00023-1145-01 90 days supply.
    Category
    Drug
    Distribution
    5 states
  • HighFDA (Devices)·Z-1798-2018·2018-05-16

    Inpeco Laboratory Automation Systems Recalled for Module Freezing Risk

    Inpeco S.A. is recalling 18 laboratory automation systems because a module may freeze without warning, potentially delaying patient test results.

    Product
    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (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
  • HighFDA (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 ad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1635-2018·2018-05-16

    Vygon U.S.A. Recalls Maximum Barrier Tray Due to Sterility Risk

    Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code AMS-9018CP) because potential friction holes may compromise product sterility.

    Product
    Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2018·2018-05-16

    Abbott ARCHITECT DHEA-S Reagent Recalled for False Infant Results

    Abbott is recalling ARCHITECT DHEA-S Reagent because it may produce falsely elevated results when used on samples from infants up to 60 days old.

    Product
    ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1727-2018·2018-05-16

    Datascope recalls custom tubing kits due to seal separation risk

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

    Product
    ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1622-2018·2018-05-16

    Boston Scientific Recalls Uphold LITE Pelvic Organ Prolapse Mesh Devices

    Boston Scientific is recalling Uphold LITE w/ Capio SLIM devices due to a potential for the Capio sutures to break or detach.

    Product
    Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·18V319000·2018-05-16

    Ford Recalls 2018 F-650 and F-750 Trucks for Parking Brake Defect

    Ford is recalling 151 2018 F-650 and F-750 trucks because improperly adjusted parking brake cables may cause unexpected vehicle movement, increasing crash risk.

    Product
    FORD — FORD F-650 SD, F-750 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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-1641-2018·2018-05-16

    Medtronic Prestige LP Cervical Disc Drill Guides Recalled for Breakage

    Medtronic is recalling specific drill guides for the Prestige LP Cervical Disc System because they may cause drill bits to break during use.

    Product
    Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1754-2018·2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage

    Cook Inc. is recalling 304 connecting tubes because the cap-adapter assembly may not tighten adequately, potentially causing fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-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-1791-2018·2018-05-16

    TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances

    TP Orthodontics is recalling five 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. 610-533Lused 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
  • HighFDA (Devices)·Z-1702-2018·2018-05-16

    Bard BrachySource Iodine-125 Radioactive Seeds Recalled for Dosage Mix-Up

    Bard Brachytherapy is recalling Iodine-125 radioactive seeds because incorrect dosage levels were mixed up and sent to two hospitals in California and Georgia.

    Product
    BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emis
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1398-2018·2018-05-16

    Ziegenfelder Recalls Sugar Free Twin Pops Due to Listeria Risk

    Ziegenfelder Company is recalling Sugar Free Twin Pops after Listeria monocytogenes was found in environmental samples at their Denver plant.

    Product
    Budget $aver Sugar Free Twin Pops Net Contents 28.2 FL OZ
    Category
    Food
    Distribution
    15 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-1695-2018·2018-05-16

    Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Change

    Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf life change was made without submitting data to demonstrate continued product efficacy.

    Product
    Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1737-2018·2018-05-16

    Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Error

    Zimmer Biomet is recalling 54 Gentle Threads Interference Screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, increasing infection risk.

    Product
    Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-1578-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 20 AirLife Resuscitation Broselow Hinkle Kits because the mask component may stick, making it difficult to disconnect from the device.

    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
  • HighFDA (Devices)·Z-1789-2018·2018-05-16

    TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances

    TP Orthodontics is recalling 7 Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.

    Product
    Jasper Vektor, Class II Correction Appliance, Part No. 610-530L 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
  • HighFDA (Devices)·Z-1732-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Seal Separation Risk

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

    Product
    BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (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
  • HighFDA (Devices)·Z-1786-2018·2018-05-16

    TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances

    TP Orthodontics is recalling 119 Jasper Vektor Class II Correction Appliances because the devices have broken in patients' mouths, posing a risk of injury.

    Product
    Jasper Vektor, Class II Correction Appliance, Part No. 610-533 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
  • HighFDA (Devices)·Z-1618-2018·2018-05-16

    Boston Scientific Recalls Capio CL Sutures Due to Breakage Risk

    Boston Scientific is recalling 1,258 Capio CL sutures because they may break or detach during transvaginal procedures.

    Product
    Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1794-2018·2018-05-16

    TP Orthodontics Recalls Jasper Vektor Class II Correction Appliance

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

    Product
    Jasper Vektor, Class II Correction Appliance, Part No. 610-536L 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
  • HighFDA (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 adequa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1638-2018·2018-05-16

    Vygon Recalls Maximum Barrier Tray Due to Potential Sterility Compromise

    Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code MCITX-1) because potential friction holes may affect the product's sterility.

    Product
    Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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
  • HighFDA (Devices)·Z-1556-2018·2018-05-16

    Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 180 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, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 adequat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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
  • 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-1639-2018·2018-05-16

    Vygon Recalls PICC Insertion Trays Due to Potential Sterility Issues

    Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the sterility of the product.

    Product
    PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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
  • HighFDA (Devices)·Z-1568-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 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, 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 breathe on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2018·2018-05-16

    DePuy Recalls Two Knee Implants Due to Thread Burrs

    DePuy Orthopaedics is recalling two ATTUNE Revision CRS Femoral LT knee implants because burrs may be present on the extraction hole threads.

    Product
    ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1776-2018·2018-05-16

    Transonic ADT1018 Hemodialysis Tubing Recalled Due to Sterility Concerns

    Transonic Systems Inc. is recalling ADT1018 Flow QC Clear Advantage Tubing because the sterility of the device cannot be assured, posing a potential risk of infection.

    Product
    Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements duri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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 bre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2018·2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Fluid Leakage

    Cook Inc. is recalling 220 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, HPCT8.8-60-M-FM-BNS 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 radiograp
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (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 the
    Category
    Medical Device
    Distribution
    Distributed nationwide

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