The Recall Desk

Archive

August 2019 recalls

831 recalls were announced in August 2019.

What the numbers show

Critical
20
Severe
249
High
270
Moderate
249
Low
43

Of the 831 recalls this month scored against our rubric, 2% are Critical, 30% are Severe.

1–100 of 831

  • ModerateUSDA FSIS·089-2019·2019-08-31

    American Beef Packers Recalls Raw Beef Products Deemed Unfit for Human Consumption

    American Beef Packers is recalling approximately 24,428 pounds of raw beef products deemed unfit for human consumption after a carcass was erroneously released before test results were received.

    Product
    American Beef Packers, Inc. — American Beef Packers, Inc. Recalls Raw Beef Products Deemed Unfit for Human Consumption
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·19V640000·2019-08-30

    Lion Recalls 2018 Electric School Buses Due to Brake Connector Issue

    Lion Electric Company is recalling 2018 Lion C electric school buses because loose auxiliary brake pump connectors may cause loss of braking ability if the main pump fails.

    Product
    LION — LION LIONC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19C001000·2019-08-30

    WAYB Recalls Pico Child Seats Due to Headrest Frame Breakage Risk

    WAYB is recalling Pico child seats manufactured between February and August 2019 because the headrest frame can break and detach, increasing injury risk in a crash.

    Product
    CHILD SEAT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·088-2019·2019-08-30

    Heatherfield Foods Recalls Pork Sausage Due to Gluten Mislabeling

    Heatherfield Foods is recalling pork sausage products labeled as gluten-free that contain wheat. The recall affects retail locations in Hawaii.

    Product
    Heatherfield Foods LLC — Heatherfield Foods Inc. Recalls Pork Sausage Products Due to Misbranding
    Category
    Food
    Distribution
    1 state
  • HighCPSC·19196·2019-08-30

    RH Recalls Ultra-Soft Turkish Robes for Flammability Standard Violations

    RH is recalling about 5,400 Ultra-Soft Turkish robes because they fail federal flammability standards, posing a burn risk. Consumers should stop using them and request a refund.

    Product
    Ultra-Soft Turkish robes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19775·2019-08-30

    GreatCall Recalls Lively Mobile Plus Emergency Alert Devices

    GreatCall is recalling Lively Mobile Plus emergency alert devices because the call button may fail during an emergency. No injuries have been reported.

    Product
    Lively Mobile Plus Emergency Alert Devices
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19197·2019-08-30

    RH Recalls Children's Chairs and Stools Due to Lead Paint Violation

    RH is recalling about 3,200 children's chairs and stools sold in the U.S. and Canada because the paint contains lead levels exceeding federal bans.

    Product
    Children's chairs and stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V632000·2019-08-29

    Ford Recalls 2013-2016 Fusion, MKZ, Edge, and MKX for Steering Defect

    Ford is recalling 116,160 vehicles because road salt may corrode steering bolts, causing loss of power steering assist and increasing crash risk.

    Product
    LINCOLN — LINCOLN, FORD MKZ, EDGE, FUSION, MKX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V637000·2019-08-29

    Chrysler Recalls 2019-2020 Jeep Cherokee for Steering Rack Gear Defect

    Chrysler is recalling 2019-2020 Jeep Cherokee vehicles because the steering rack gear may break, potentially causing a loss of steering control and increasing crash risk.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19193·2019-08-29

    Rite Aid Recalls Folding Patio Chairs Due to Fall Hazard

    Rite Aid is recalling about 18,800 folding patio chairs because the frames can bend, causing users to fall and potentially get injured.

    Product
    Folding patio chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19195·2019-08-29

    Pearhead Recalls Ubbi Connecting Bath Toys Due To Choking Hazard

    Pearhead is recalling Ubbi Connecting Bath Toys because they can break and create sharp points, posing choking and laceration hazards to young children.

    Product
    Ubbi Connecting Bath Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V635000·2019-08-29

    2019 Ram 2500 and 3500 Trucks Recalled for Brake Caliper Defect

    FCA US is recalling 2019 Ram 2500 and 3500 trucks because incorrect assembly fluid in brake calipers may cause seals to swell, leading to dragging brakes and increased crash risk.

    Product
    RAM — RAM 3500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19192·2019-08-29

    Decathlon Recalls Rocky Screwgate Carabiners Due to Unlocking Risk

    Decathlon USA is recalling about 50 Rocky Screwgate carabiners because incorrect assembly can cause them to unlock while in use, posing a risk of serious injury or death.

    Product
    Rocky Screwgate carabiners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2070-2019·2019-08-28

    Elevation Foods Recalls Archer Farms Egg Salad Due to Listeria

    Elevation Foods is recalling Archer Farms egg salad because Listeria monocytogenes was found in the product. The recall covers 572 cases distributed to multiple states.

    Product
    Archer Farms egg salad packaged in 12oz plastic cup with lid, 6 cups per case, refrigerated
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-2090-2019·2019-08-28

    Dole Baby Spinach Recalled Due to Positive Salmonella Test

    Dole Fresh Vegetables is recalling specific lots of Dole Baby Spinach after a Michigan state test detected Salmonella.

    Product
    Dole Baby Spinach: 6 oz. (170 g) plastic bag, UPC 0-71430-00964-2, SKU 320; 10 oz. (283 g) clamshell, UPC 0-71430-00016-8, SKU 2337 Distributed by: Dole Fresh Vegetables, Inc., Monterey, CA 93940.
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-2076-2019·2019-08-28

    Kroger Private Selection Frozen Blackberries Recalled for Hepatitis A Risk

    The Kroger Co is recalling 16 oz packages of Private Selection Frozen Blackberries due to possible Hepatitis A contamination. The product was distributed to retail locations in 30 states.

    Product
    PRIVATE SELECTION FROZEN BLACKBERRIES, 16 oz
    Category
    Food
    Distribution
    30 states
  • CriticalFDA (Devices)·Z-2226-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems due to reports of burst balloons that caused difficulty retrieving the device during procedures.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
    Category
    Medical Device
    Distribution
    12 states
  • CriticalFDA (Food)·F-2075-2019·2019-08-28

    Kroger Frozen Triple Berry Medley Recalled for Possible Hepatitis A

    The Kroger Co is recalling Private Selection Frozen Triple Berry Medley due to possible Hepatitis A contamination. Consumers should check their freezers for the affected product.

    Product
    PRIVATE SELECTION FROZEN TRIPLE BERRY MEDLEY, 16 oz
    Category
    Food
    Distribution
    30 states
  • CriticalFDA (Food)·F-2074-2019·2019-08-28

    Kroger Frozen Triple Berry Medley Recalled for Possible Hepatitis A

    The Kroger Co is recalling Private Selection Frozen Triple Berry Medley due to possible Hepatitis A contamination. Consumers should discard the product.

    Product
    PRIVATE SELECTION FROZEN TRIPLE BERRY MEDLEY, 48 oz
    Category
    Food
    Distribution
    30 states
  • CriticalFDA (Food)·F-2077-2019·2019-08-28

    Kirkland Signature Three Berry Blend Recalled for Hepatitis A Risk

    Townsend Farms Inc. is recalling Kirkland Signature Three Berry Blend frozen berries due to potential Hepatitis A virus contamination.

    Product
    Kirkland Signature Three Berry Blend product, frozen, package in a plastic bag. Net wt. 4 lbs. UPC 0 96619 10105 4. The product label is read in parts: "*** KIRKLAND Signature *** Three Berry Blend *** Raspberries***Blueberries***Blackberries*** PRODUCT OF USA *** Distributed
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2227-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems because burst balloons can make it difficult to remove the device from patients.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2224-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling 362 units of the SAPIEN 3 Ultra Transcatheter Heart Valve System due to reports of burst balloons that complicate device retrieval.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
    Category
    Medical Device
    Distribution
    12 states
  • SevereCPSC·19774·2019-08-28

    Yamaha Recalls Golf Cars and Specialty Vehicles Due to Fire Hazard

    Yamaha is recalling about 16,000 golf cars and specialty vehicles because a USB power module can overheat and melt, posing a fire hazard.

    Product
    Yamaha golf cars, personal transportation and specialty vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·087-2019·2019-08-28

    Bakkavor Recalls Chicken Salad for Undeclared Pecans and Misbranding

    Bakkavor Foods USA is recalling 1,913 pounds of ready-to-eat chicken salad products due to undeclared pecans and misbranding. The products were shipped to retail grocery locations in Texas.

    Product
    Bakkavor US - San Antonio — Bakkavor Foods USA, Inc. Recalls Ready-To-Eat Chicken Salad Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2295-2019·2019-08-28

    Arcos Burn Navigator H2 Recalled for Battery Fire Risk

    Arcos, Inc. is recalling 28 Burn Navigator H2 units because their battery packs may heat up abnormally and ignite in rare instances.

    Product
    Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523
    Category
    Medical Device
    Distribution
    6 states
  • SevereNHTSA·19V628000·2019-08-28

    Jayco Eagle HT Fifth Wheel Trailers Recalled for Pin Box Bolt Defect

    Jayco is recalling 2019-2020 Eagle HT fifth wheel trailers because incorrect pin box bolts may allow the box to rotate in two places, increasing crash risk.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL EAGLE HT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2073-2019·2019-08-28

    Elevation Foods Recalls Fresket Thai Lobster Salad Due to Listeria Risk

    Elevation Foods is recalling Fresket Thai Lobster Salad because Listeria monocytogenes was found in egg salad produced on the same line and date.

    Product
    Fresket Thai Lobster Salad packaged in 5lb plastic container, 2 containers per case, refrigerated
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-2079-2019·2019-08-28

    Ruleau Bros Recalls Smoked Whitefish Pate for Undeclared Allergens

    Ruleau Bros, Inc. is recalling Smoked Whitefish Pate because it contains undeclared anchovy, egg, and soy.

    Product
    Door County Whitefish Smoked Whitefish Pate 8oz plastic tub UPC 8 55356 00402 4 Keep Refrigerated 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2225-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems due to reports of burst balloons that caused significant difficulty retrieving the device during procedures.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
    Category
    Medical Device
    Distribution
    12 states
  • SevereNHTSA·19V634000·2019-08-28

    2020 MINI Cooper and JCW Recalled for Missing Rear Crash Pads

    BMW is recalling 2020 MINI Cooper, Cooper S, and JCW vehicles because rear side trim panels may lack crash pads, increasing injury risk in side impacts.

    Product
    MINI — MINI JCW, COOPER, COOPER S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V631000·2019-08-28

    BMW Recalls 2020 X5 and X7 Models for Steering Rack Defect

    BMW is recalling 2020 X5 and X7 vehicles because steering rack pinion teeth may break, causing loss of steering control and increasing crash risk.

    Product
    BMW — BMW X7, X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E058000·2019-08-28

    ZF Recalls Steering Center Rods for 1996-2004 BMW 5 Series

    ZF North America is recalling aftermarket steering center rods for 1996-2004 BMW 5 Series vehicles due to a risk of detachment causing loss of steering control.

    Product
    BMW — BMW 5 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V625000·2019-08-28

    Jayco Recalls 2019 Embark Motorhomes Due to Steering Shaft Bolt Issue

    Jayco is recalling 2019 Embark motorhomes because insufficiently tightened steering shaft bolts may allow the steering column to come loose, increasing crash risk.

    Product
    JAYCO — JAYCO EMBARK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2099-2019·2019-08-28

    Makzemo LLC Recalls BALQEES SPICES Yemeni Spices Mix Due to Lead

    Makzemo LLC is recalling BALQEES SPICES Yemeni Spices Mix because the product contains high levels of lead. The recall affects 600 units distributed in New York and Michigan.

    Product
    BALQEES SPICES, Yemeni Spices Mix, NET WEIGHT: 230g (1/2 lb.) and 454 grams (1lb.) clear plastic container and 5 lbs. clear plastic bag. Distributed By: Makzemo LLC, 7304 5th Avenue # 112, Brooklyn, NY 11209, (718) 219-6630, Ingredients, Turmeric, Black Pepper, Cumin, Coriander,
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1843-2019·2019-08-28

    SCA Pharmaceuticals Recalls Ketamine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 922 syringes of Ketamine 50 mg/5 mL injection due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V633000·2019-08-28

    Ford Recalls 639,137 Vehicles for Defective Seat Back Recliner Mechanisms

    Ford is recalling 639,137 vehicles because a missing part in the seat back recliner mechanism may reduce strength and fail to restrain occupants in a crash.

    Product
    FORD — FORD, LINCOLN F-150, ESCAPE, F-550, EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·19189·2019-08-28

    Whirlpool Recalls Glass Cooktops with Touch Controls Due to Burn and Fire Hazards

    Whirlpool is recalling about 26,300 glass cooktops with touch controls because the surface elements can turn on by themselves, posing burn and fire hazards.

    Product
    Whirlpool, KitchenAid and JennAir brand glass cooktops with touch controls
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·19190·2019-08-28

    Kirkland's Recalls Chests of Drawers Due to Tip-Over and Entrapment Hazards

    Kirkland's is recalling about 3,000 chests of drawers because they are unstable if not anchored to the wall, posing tip-over and entrapment hazards.

    Product
    Black Wash Mirrored Chests and Six-Drawer Camille Chests
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V630000·2019-08-28

    Pierce Recalls 2019 Tanker Vehicles Due to Front Axle Lubrication Defect

    Pierce Manufacturing is recalling one 2019 Pierce Tanker vehicle because insufficient front axle lubrication may damage wheel end bearings, potentially causing wheel separation and loss of control.

    Product
    PIERCE — PIERCE TANKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2019·2019-08-28

    DeRoyal Enteral Safe Feeding Tubes Recalled for Connector Detachment

    DeRoyal Industries is recalling specific polyurethane feeding tubes because the connector may detach from the tube.

    Product
    DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8 FR x 24" Polyurethane d) REF 54-3680R, 8 FR x 36" Polyurethane Product Usage: Feeding tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2308-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling specific blood collection tubes because they can cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2304-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling specific blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2019·2019-08-28

    Siemens N Cuvette Segments Recalled for Falsely Elevated Albumin Results

    Siemens Healthcare Diagnostics is recalling N Cuvette Segments for the BN ProSpec System because they may produce falsely elevated albumin results.

    Product
    N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2352-2019·2019-08-28

    Siemens ACUSON NX3 Ultrasound Systems Recalled for Acoustic Output Power Defect

    Siemens is recalling 1,384 ACUSON NX3 diagnostic ultrasound systems worldwide because internal testing found transducers may exceed defined acoustic output power values.

    Product
    ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004297 The ACUSON NX2 diagnostic ultrasound imaging systems are intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2057-2019·2019-08-28

    Keto Farms Strawberry Gouda Snack Mix Recalled for Undeclared Coconut

    Keto Farms is recalling Strawberry Gouda snack mix because an inspection found undeclared coconut on the label.

    Product
    Keto Farms Keto Snack Mix - Strawberry Gouda; Fruit & Cheese Mix with Sprouted Pecans & Almonds; Net Wt. 95 g (3.34 oz.) Ingredients: Gouda Cheese (Pasteurized Milk, Cheese Culture, Salt, Enzymes), Sprouted Organic Pecans, Sprouted Transitional Almonds, Strawberries, MCT Oil
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2345-2019·2019-08-28

    Siemens MAGNETOM Prisma MRI Devices Recalled for Quench Venting Port Issue

    Siemens is recalling 17 MAGNETOM Prisma MRI devices due to a potential open port in the quench venting system when using the optional horizontal outlet.

    Product
    MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2306-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer PST Blood Collection Tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2081-2019·2019-08-28

    Rock Garden Fresh Basil Recalled for Potential Cyclospora Contamination

    Herbs Unlimited is recalling Rock Garden brand fresh basil due to potential Cyclospora contamination. The product was distributed to Publix and other distributors.

    Product
    Fresh basil with Rock Garden brand label. Basil was packed in 1 lb. plastic bags and in 0.75 oz. clear plastic clamshell containers.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2289-2019·2019-08-28

    Siemens IMMULITE 1000 Progesterone Test Recall for Low Results

    Siemens is recalling IMMULITE 1000 Progesterone tests because they may produce falsely low results, potentially leading to unnecessary progesterone supplementation.

    Product
    IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2019·2019-08-28

    Luminex Aries M1 Barcode Scanner Recall for Sample Mismatch Risk

    Luminex is recalling Aries M1 barcode scanners due to incorrect control boards that could cause patient sample mismatches or duplicate results.

    Product
    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2320-2019·2019-08-28

    Radiometer ABL90 FLEX Analyzer Recalled for Software Security Vulnerabilities

    Radiometer America Inc is recalling ABL90 FLEX Analyzers due to software security vulnerabilities that may cause device shutdowns or reboots, potentially delaying medical treatment.

    Product
    ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-2298-2019·2019-08-28

    BD Vacutainer Lithium Heparin Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2071-2019·2019-08-28

    Elevation Foods Recalls Fresket Egg Salad Due to Listeria Monocytogenes

    Elevation Foods is recalling Fresket egg salad because Listeria monocytogenes was found in the product. The recall covers specific cases distributed to multiple states.

    Product
    Fresket egg salad packaged in 32oz plastic cup with lid, 2 cups per case, refrigerated
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-2072-2019·2019-08-28

    Elevation Foods Recalls Fresket Tuna Salad Due to Listeria Risk

    Elevation Foods is recalling Fresket Tuna Salad because Listeria monocytogenes was found in egg salad produced on the same line.

    Product
    Fresket Tuna Salad packaged in 5lb plastic container, 2 containers per case, refrigerated
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2305-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling specific blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2019·2019-08-28

    BD Vacutainer Lithium Heparin Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2082-2019·2019-08-28

    Mariposa Farms Basil Recalled Due to Possible Cyclospora Link

    Mariposa Farms is recalling basil due to a possible link to a cyclospora illness outbreak. Consumers should check for Lot # 6985.

    Product
    Mariposa Farms Basil, Net Wt. 0.75 OZ, in plastic clamshell containers for retail sale. Mariposa Farms, Inc. Grinnell, IA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2350-2019·2019-08-28

    Siemens ACUSON NX2 Ultrasound Systems Recalled for Acoustic Output Power Defect

    Siemens is recalling ACUSON NX2 ultrasound systems because internal testing found transducers may exceed defined acoustic output power values.

    Product
    ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2019·2019-08-28

    TiSport Recalls TiLite Wheelchair Anti-Tip Tubes for Tipping Risk

    TiSport is recalling 1,452 TiLite wheelchairs because the anti-tip tubes may fail, allowing the chair to tip backwards.

    Product
    TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is part of a manual wheelchair to provide mobility to phys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2353-2019·2019-08-28

    Siemens ACUSON NX3 Ultrasound Systems Recalled for Acoustic Output Power Defect

    Siemens is recalling ACUSON NX3 Elite ultrasound systems because internal testing found transducers may exceed defined acoustic output power values.

    Product
    ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 The ACUSON NX2 diagnostic ultrasound imaging systems are int
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2058-2019·2019-08-28

    Keto Farms Recalls Snack Mix Due to Undeclared Coconut Allergen

    Keto Farms LLC is recalling specific varieties of Keto Snack Mix because the label failed to declare coconut, a major allergen. The recall covers 2,762 units distributed in the US, Canada, and several other countries.

    Product
    Keto Farms Keto Snack Mix - Tomato Pepperjack Fruit & Cheese Mix with Sprouted Pecans & Walnuts; Net Wt. 95 g (3.34 oz. Ingredients: Monterey Jack Cheese with Jalapeno Peppers, (Pasteurized Milk, Jalapeno Peppers, Cheese Culture, Salt, Enzymes), Sprouted Organic Walnuts, S
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2066-2019·2019-08-28

    Green Water Recalls Taspens Organics Tea and Herbal Tinctures for Salmonella

    Green Water, LLC is recalling Taspens Organics tea and herbal tinctures due to potential Salmonella contamination. The products were distributed nationwide.

    Product
    Taspens Organics, Organic Tea: Mothers Milk, 2 ounce.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2303-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling specific blood collection tubes because they may cause falsely elevated carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V627000·2019-08-28

    Toyota and Pontiac Recall Vehicles for Front Passenger Air Bag Defect

    Toyota and GM are recalling specific Corolla, Corolla Matrix, and Pontiac Vibe vehicles because the front passenger air bag may not inflate properly in high temperatures.

    Product
    PONTIAC — PONTIAC, TOYOTA VIBE, COROLLA, COROLLA MATRIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2307-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer PST Gel and Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2349-2019·2019-08-28

    Thoratec Heartmate 3 Sealed Outflow Graft Recall for Leak Risk

    Thoratec Corp. is recalling 149 Heartmate 3 Sealed Outflow Graft units because the C-Ring may not seat properly, causing leaks during implantation.

    Product
    Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2019·2019-08-28

    BD Vacutainer Lithium Heparin Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2019·2019-08-28

    Siemens IMMULITE 2000 Progesterone Test Recalled for Potential Low Results

    Siemens is recalling IMMULITE 2000 Progesterone tests because some samples may produce falsely low results, potentially leading to unnecessary medication.

    Product
    IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2078-2019·2019-08-28

    Hannaford Quiche Recalled for Missing Allergen Labeling

    Meninno Brothers Gourmet Foods is recalling Hannaford brand quiche because the label lacks an ingredient or allergen statement.

    Product
    Hannaford brand 20 oz. traditional quiche w/tomatoes, cheese and basil in flexible plastic with round top and bottom.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2061-2019·2019-08-28

    Green Water Recalls Multiple Herbal Tinctures and Teas Due to Salmonella Risk

    Green Water, LLC is recalling several herbal tinctures and teas due to potential Salmonella contamination. The products were distributed nationwide.

    Product
    Taspen s Organics, Breathe Easy Herbal Tincture, Net wt 1 ounce, 2 ounce, 4 ounce
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2083-2019·2019-08-28

    SIGA Fresh Basil Recalled for Potential Cyclospora Contamination

    SIGA Logistics is recalling 1 lb bags of fresh basil due to potential Cyclospora contamination. The product was distributed in several US states.

    Product
    SIGA Fresh Basil, 1 lb bag, 10 plastic bags (1 lb bag) per carton
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2301-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling specific blood collection tubes because they may cause falsely elevated carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2064-2019·2019-08-28

    Green Water Recalls Multiple Herbal Tinctures and Teas Due to Salmonella Risk

    Green Water, LLC is recalling several herbal tinctures and teas due to potential Salmonella contamination. The products were distributed nationwide.

    Product
    Taspen s Organics,Mojo Magic Herbal Tincture, Net wt 1 ounce, 2 ounce, 4 ounce
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2309-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they can cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2319-2019·2019-08-28

    Qiagen QIAsymphony SP Software 5.0.3 Recalled for Barcode Assignment Error

    Qiagen is recalling QIAsymphony SP software version 5.0.3 because it incorrectly assigns 2D barcode eluate IDs to samples, which could lead to incorrect patient reporting.

    Product
    QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2060-2019·2019-08-28

    Green Water Recalls Multiple Herbal Tinctures and Teas Due to Salmonella Risk

    Green Water, LLC is recalling specific lots of Taspen's Organics herbal tinctures and teas due to potential Salmonella contamination. The products were distributed nationwide.

    Product
    Taspen s Organics, Bedroom Bliss Herbal Tincture, Net wt 1 ounce, 2 ounce, 4 ounce
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2068-2019·2019-08-28

    Nosh Organic Fruit and Protein Soft Oat Bars Recalled for Mold Contamination

    First Start Holdings is recalling Nosh Organic Fruit & Protein Soft Oat Bars due to potential mold contamination. The product was distributed nationwide through three US distributors and the company's website.

    Product
    Nosh Organic Fruit & Protein Soft Oat Bar; Apple, Sweet Potato & Cinnamon. 6 - 0.74 oz. (21 g) bars per box. Net Wt. 4.44 oz. 126g) Ingredients: Organic Whole Grain Rolled Oats, Organic, Tapioca Syrup, Organic Sunflower Seed Protein, Organic Sunflower Oil, Organic Date Paste,
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2299-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2063-2019·2019-08-28

    Green Water Recalls Multiple Herbal Tinctures and Teas Due to Salmonella Risk

    Green Water, LLC is recalling several herbal tinctures and teas due to potential Salmonella contamination. The products were distributed nationwide.

    Product
    Taspen s Organics,Happy Momma Herbal Tincture, Net wt 1 ounce, 2 ounce, 4 ounce
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2062-2019·2019-08-28

    Green Water Recalls Multiple Herbal Tinctures and Teas for Salmonella Risk

    Green Water, LLC is recalling several herbal tinctures and teas due to potential Salmonella contamination. The products were distributed nationwide.

    Product
    Taspen s Organics,Digest Ease Herbal Tincture, Net wt 1 ounce, 2 ounce, 4 ounce
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2348-2019·2019-08-28

    Thoratec HeartMate 3 LVAS Implant Kit Recalled for Outflow Graft Leaks

    Thoratec Corp. is recalling HeartMate 3 LVAS Implant Kits because an insufficiently seated C-Ring can cause the outflow graft to leak during implantation, rendering the device nonfunctional.

    Product
    Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2296-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2343-2019·2019-08-28

    Siemens MAGNETOM Skyra MRI Devices Recalled for Quench Venting System Defect

    Siemens is recalling 44 MAGNETOM Skyra MRI devices due to a potential open port in the quench venting system when using an optional horizontal outlet.

    Product
    MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Food)·F-2059-2019·2019-08-28

    Keto Farms Recalls Raspberry Gouda Snack Mix for Undeclared Coconut

    Keto Farms LLC is recalling its Raspberry Gouda Fruit & Cheese Mix because an inspection found that coconut, a declared allergen, was missing from the label.

    Product
    Keto Farms Keto Snack Mix - Raspberry Gouda Fruit & Cheese Mix with Sprouted Almonds & Walnuts; Net Wt. 95 g (3.34 oz. Ingredients: Gouda Cheese (Pasteurized Milk, Cheese Culture, Salt, Enzymes), Sprouted Organic Walnuts, Sprouted Transitional Almonds, Raspberries, MCTOil,
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2330-2019·2019-08-28

    BD MAX Enteric Bacterial Panel Extraction Tube Sealing Defect Recall

    Becton Dickinson is recalling BD MAX Enteric Bacterial Panel kits because foil bags containing extraction tubes may not have been sealed properly.

    Product
    Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Drugs)·D-1826-2019·2019-08-28

    Medtech Recalls Clear Eyes Assorted Displays Due to Quality Control Concerns

    Medtech Products is recalling Clear Eyes Assorted IRC Displays due to concerns about quality assurance controls in the manufacturing facility.

    Product
    Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochlorid
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1835-2019·2019-08-28

    Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues

    Medtech Products, Inc. is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls in the manufacturing facility.

    Product
    Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1823-2019·2019-08-28

    Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues

    Medtech Products is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls in the manufacturing facility.

    Product
    Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Dist. by Lil' Drug Store Products Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402; Medtech Products Inc., Tarrytown, NY 10591, UPC 7 92554
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2323-2019·2019-08-28

    BD Max ExK DNA 1 USA Extraction Tube Sealing Defect Recall

    Becton Dickinson is recalling 115 units of BD Max ExK DNA 1 USA kits because foil bags containing extraction tubes may not be sealed properly.

    Product
    Kit BD Max ExK DNA 1 USA; Catalog # 442817
    Category
    Medical Device
    Distribution
    38 states

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