The Recall Desk

Archive

March 2018 recalls

766 recalls were announced in March 2018.

What the numbers show

Critical
16
Severe
113
High
287
Moderate
299
Low
51

Of the 766 recalls this month scored against our rubric, 2% are Critical, 15% are Severe.

1–100 of 766

  • CriticalUSDA FSIS·028-2018·2018-03-31

    PFP Enterprises Recalls Raw Beef Produced Without Federal Inspection

    PFP Enterprises is recalling approximately 7,146 pounds of raw beef products produced without federal inspection. Consumers are urged to discard or return the items.

    Product
    Patterson TMP Operating, LLC — PFP Enterprises LLC Recalls Raw Beef Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    9 states
  • HighNHTSA·18V209000·2018-03-30

    Van Hool Recalls Motorcoaches Due to Seat Belt Buckle Casing Failure

    Van Hool is recalling 2015-2018 motorcoaches because seat belt buckle casings may fail, exposing the buckles and reducing the likelihood of seat belt use.

    Product
    VAN HOOL — VAN HOOL CX45, TD925, TDX25, CX35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V206000·2018-03-29

    Spartan Gladiator Recall for Front Axle Spindle Failure Risk

    Spartan Motors is recalling 2004-2007 Gladiator emergency response vehicles because front axle spindles may crack and fail, potentially causing a wheel to separate.

    Product
    SPARTAN — SPARTAN GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V204000·2018-03-29

    Tesla Recalls Model S Vehicles Due to Steering Bolt Corrosion Risk

    Tesla is recalling 2012-2016 Model S vehicles because aluminum steering bolts may corrode and fracture, potentially causing a loss of power steering assist.

    Product
    TESLA — TESLA MODEL S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E017000·2018-03-29

    Timoney Front Suspension Recall Due to Axle Spindle Fatigue Cracks

    Timoney Technology is recalling Mark 1 and Gen 2 Independent Front Suspensions because inconsistent machining may cause axle spindle failure and wheel separation.

    Product
    SUSPENSION:FRONT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V208000·2018-03-29

    Mercedes-Benz Recalls 2018 Models for Driver Air Bag Inflator Defect

    Mercedes-Benz is recalling 2018 AMG GT, AMG GT C, GLC43 AMG, GLC300, and GLC350e vehicles because defective steel in the driver-side air bag inflator housing may cause rupture during deployment.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLC 350 E, GLC 300, AMG GLC43, AMG GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V199000·2018-03-29

    Navistar Recalls 2018-2019 International LT Trucks for Fuel Leak Risk

    Navistar is recalling 2018-2019 International LT trucks because a fender splash panel may rub against the fuel line, causing a leak that could lead to fire or crash.

    Product
    INTERNATIONAL — INTERNATIONAL LT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V203000·2018-03-29

    Alfa Romeo Stelvio Recall for Liftgate Wiring Water Leak

    FCA US LLC is recalling 2018 Alfa Romeo Stelvio vehicles because water leaks into liftgate wiring, causing corrosion that may allow the liftgate to open while driving.

    Product
    ALFA ROMEO — ALFA ROMEO STELVIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V205000·2018-03-29

    Alfa Romeo Stelvio Recall for Water-Induced Electrical Corrosion

    FCA US LLC is recalling 2018 Alfa Romeo Stelvio vehicles because water leaks into the body control module, causing electrical malfunctions that increase crash risk.

    Product
    ALFA ROMEO — ALFA ROMEO STELVIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V207000·2018-03-29

    Mercedes-Benz Recalls 2017-2018 Models Due to Front Seatback Locking Defect

    Mercedes-Benz is recalling specific 2017-2018 C-Class and E-Class vehicles because front seatbacks may not lock properly, increasing injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E 400, C 300, AMG C63S, AMG C43
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·027-2018·2018-03-29

    Target Recalls Frozen Meat and Poultry Due to Temperature Abuse

    Target is recalling frozen meat and poultry sold at a single Hawaii store due to temperature abuse during transport that may have allowed pathogen growth.

    Product
    Target Corporation Recalls Frozen Ready-To-Eat and Non-Ready-To-Eat Meat and Poultry Products due to Possible Temperature Abuse During Transport at a Single Store on Oahu, Honolulu, HI
    Category
    Food
    Distribution
    1 state
  • HighCPSC·18733·2018-03-29

    Residential Elevators Recalls Traction Elevators Due to Impact Hazard

    Residential Elevators Inc. is recalling about 3,700 traction elevators installed in homes between January 2015 and April 2017 because the cab can rise unexpectedly to the top of the shaft, posing an impact hazard.

    Product
    Traction elevators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18132·2018-03-29

    Primo Recalls hTrio Beverage Dispensers Due to Burn Hazard

    Primo is recalling hTrio beverage dispensers because hot water may leak at high altitudes, posing a burn risk.

    Product
    Primo hTrio Multi-purpose beverage dispensers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18734·2018-03-29

    Octane Fitness Recalls XT-One Elliptical Cross Trainers Due to Fall Hazard

    Octane Fitness is recalling about 570 XT-One elliptical cross trainers because the incline lead screw can shear off, causing foot pedals to drop unexpectedly and creating a fall hazard.

    Product
    Octane Fitness XT-One elliptical cross trainers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1526-2018·2018-03-28

    FDA Recalls Kratom Capsules Due to Potential Salmonella Contamination

    Pdx Aromatics is recalling specific lots of Kraken Kratom, Phytoextractum, and Soul Speciosa Green Vein Kratom capsules due to potential Salmonella contamination.

    Product
    GREEN Kratom CAPSULES, sold under brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. The capsules are packaged in plastic heat sealed pouches. Each package sold in 28 grams (1 ounce), 56 grams (2 ounces), 112 grams (4 ounces). The varieties under each brand includ
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1523-2018·2018-03-28

    Red Vein Kratom Powder Recalled for Potential Salmonella Contamination

    Pdx Aromatics is recalling Red Vein Kratom Powder products sold under Kraken Kratom, Phytoextractum, and Soul Speciosa brands due to potential Salmonella contamination.

    Product
    RED Vein Kratom POWDER, sold under brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. The powder is packaged in plastic heat sealed pouches. Each package sold in 28 grams (1 ounce), 56 grams (2 ounces), and 112 grams (4 ounces). The varieties under each brand include:
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1525-2018·2018-03-28

    FDA Recalls Kratom Capsules Due to Potential Salmonella Contamination

    Pdx Aromatics is recalling White Vein Kratom capsules sold under three brands due to potential Salmonella contamination.

    Product
    WHITE VEIN Kratom CAPSULES, sold under brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. The capsules are packaged in plastic heat sealed pouches. Each package sold in 28 grams (1 ounce), 56 grams (2 ounces), 112 grams (4 ounces). The varieties under each brand i
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1528-2018·2018-03-28

    Pdx Aromatics Recalls Kratom Capsules Due to Salmonella Contamination

    Pdx Aromatics is recalling specific lots of RED Vein Kratom Capsules sold under three brands due to potential Salmonella contamination.

    Product
    RED Kratom CAPSULES, sold under brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. The capsules are packaged in plastic heat sealed pouches. Each package sold in 28 grams (1 ounce), 56 grams (2 ounces), 112 grams (4 ounces). The varieties under each brand include:
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1527-2018·2018-03-28

    Pdx Aromatics Recalls Kratom Powder Due to Salmonella Contamination

    Pdx Aromatics is recalling specific lots of Kraken Kratom, Phytoextractum, and Soul Speciosa GREEN VEIN Kratom POWDER due to potential Salmonella contamination.

    Product
    GREEN Kratom POWDER, sold under brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. The powder are packaged in plastic heat sealed pouches. Each package sold in 28 grams (1 ounce), 56 grams (2 ounces), 112 grams (4 ounces). The varieties under each brand include:
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1133-2018·2018-03-28

    Boston Scientific Recalls SpyScope DS Biliary Catheters Due to Sleeve Defect

    Boston Scientific is recalling 5,026 units of SpyScope DS Access and Delivery diagnostic biliary catheters because a sleeve may protrude, causing tissue damage or bleeding.

    Product
    SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1124-2018·2018-03-28

    MedComp Recalls 12F Tesio Catheter Sets Due to Connection Failure Risk

    Medical Components, Inc. is recalling 12F Tesio Catheter Sets because connection failures may cause blood loss or air emboli.

    Product
    12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1125-2018·2018-03-28

    MedComp Two Part Adapter Recall for Potential Connection Failures

    Medical Components, Inc. is recalling 35 MedComp Two Part Adapter kits due to potential connection failures that could cause blood loss or air emboli.

    Product
    TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1100-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage

    Boston Scientific is recalling Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.

    Product
    Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1127-2018·2018-03-28

    MedComp Repair Kit Recalled for Potential Connection Failures and Blood Loss Risk

    Medical Components, Inc. is recalling 1,575 MedComp Repair Kits due to potential connection failures that could lead to blood loss or air emboli.

    Product
    REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1524-2018·2018-03-28

    Pdx Aromatics Recalls Kratom Powder Due to Salmonella Contamination Risk

    Pdx Aromatics is recalling specific lots of White Vein Kratom Powder sold under three brands due to potential Salmonella contamination.

    Product
    WHITE VEIN Kratom POWDER, sold under brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. The powder is packaged in plastic heat sealed pouches. Each package sold in 28 grams (1 ounce), 56 grams (2 ounces), 112 grams (4 ounces), and 225 grams. The varieties under each b
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·18V200000·2018-03-28

    Toyota Recalls 2018 Camry Vehicles Due to Engine Piston Defect

    Toyota is recalling 2018 Camry vehicles with 2.5L engines because oversized pistons may cause the engine to stall, increasing crash risk.

    Product
    TOYOTA — TOYOTA CAMRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V201000·2018-03-28

    LGS Recalls 2018 Pace, Look, and Cargo Express Cargo Trailers

    LGS Industries is recalling 2018 Pace, Look, and Cargo Express cargo trailers because a spindle weld on the axle may fail, potentially causing loss of vehicle control.

    Product
    PACE — PACE, CARGO EXPRESS, LOOK CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1122-2018·2018-03-28

    MedComp Recalls 12F Tesio Catheter Sets Due to Connection Failure Risk

    Medical Components, Inc. is recalling 385 12F Tesio Catheter Sets because connection failures may cause blood loss or air emboli.

    Product
    12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·18732·2018-03-28

    Shop LC Recalls Electric Blankets Due to Fire and Burn Hazards

    Shop LC is recalling electric heated throw blankets because the heating coils can overheat, posing fire and burn hazards.

    Product
    Electric heated micro plush flannel sherpa throw blankets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1118-2018·2018-03-28

    MedComp Recalls Catheter Repair Kits Due to Connection Failure Risk

    Medical Components, Inc. is recalling 93 Catheter Repair Kits because potential connection failures could lead to blood loss or air emboli.

    Product
    CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0939-2018·2018-03-28

    ASR Group Recalls Tank Truck Medium Invert Syrup Due to Metal

    ASR Group International Inc. is recalling approximately 50,000 wet pounds of Tank Truck Medium Invert Syrup because it may contain foreign metal material.

    Product
    Tank Truck Medium Invert Syrup (403777)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1000-2018·2018-03-28

    Guixens Food Group Recalls Dried Yellow Potatoes for Undeclared Sulfites

    Guixens Food Group, Inc. is recalling La Marinera Dried Yellow Potatoes because the product contains undeclared sulfites, a common allergen.

    Product
    La Marinera, Dried Yellow Potatoes-Papa seca amarilla, NET WEIGHT 10oz (283.5gr.), Imported/Distributed by: Guixens Food Group, Inc., Expiration date: July 2018
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1123-2018·2018-03-28

    MedComp Recalls 12F Modified Tesio Catheter Sets Due to Connection Failures

    Medical Components, Inc. is recalling 40 kits of 12F Modified Tesio Catheter Sets because connection failures could cause blood loss or air emboli.

    Product
    12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1119-2018·2018-03-28

    MedComp Repair Kit Recalled for Potential Connection Failures

    Medical Components, Inc. is recalling 5 MedComp Repair Kits due to potential connection failures that could cause blood loss or air emboli.

    Product
    REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1075-2018·2018-03-28

    Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope Recalled for Misdirected Energy

    Iridex Corporation is recalling the TruFocus LIO Premiere Laser Indirect Ophthalmoscope because laser energy was not directed as intended, causing focal cataracts and iris burns.

    Product
    Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and
    Category
    Medical Device
    Distribution
    0 states
  • SevereUSDA FSIS·026-2018·2018-03-28

    Tony Downs Recalls Chicken Products Due to Possible Plastic Contamination

    Tony Downs Foods is recalling approximately 96,384 pounds of canned chicken breast products that may contain hard plastic. The recall was initiated after two consumer complaints regarding foreign matter.

    Product
    Tony Downs Foods — Tony Downs Food Company, Inc. Recalls Chicken Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1104-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage

    Boston Scientific is recalling certain Malecot Nephrostomy Catheters because they are breaking at the mid-shaft bond during use.

    Product
    Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0981-2018·2018-03-28

    Oregon Food Bank Recalls Chia Seeds Contaminated With Rodent Droppings

    Oregon Food Bank is recalling 1 lb. packages of chia seeds due to contamination with rodent droppings. The product was distributed in Oregon and Washington.

    Product
    Chia Seeds packaged in poly film bags as both a twist type closure and a re-sealable pouch, net wt. 1 lb.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1137-2018·2018-03-28

    ESAOTE MyLab Ultrasound Systems Recalled for Probe Overheating Risk

    ESAOTE is recalling specific MyLab Ultrasound Systems because the probe head may overheat in certain settings.

    Product
    MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0194-2018·2018-03-28

    Monteris Medical Recalls NeuroBlate Systems Due to MRI Interaction

    Monteris Medical Corp is recalling 52 NeuroBlate systems used for MRI-guided neurosurgery due to an unanticipated interaction with 1.5 Tesla MRI systems.

    Product
    MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0996-2018·2018-03-28

    Avalon Packaging Recalls NXTGEN Kratom Due to Salmonella Risk

    Avalon Packaging is recalling NXTGEN Kratom dietary supplements due to the potential for Salmonella contamination. The affected product consists of 1,108 bottles of 70 capsules each.

    Product
    NXTGEN Botanicals, Maeng Da Kratom, Dietary Supplement, 70 Capsules, Made in the U.S.A
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·18V202000·2018-03-28

    REV Recalls Motorhomes Due to Potential Satellite Dish Detachment

    REV is recalling 2017-2018 motorhomes because satellite dish mounting screws may not be fastened correctly, posing a crash risk if the dish detaches.

    Product
    HOLIDAY RAMBLER — HOLIDAY RAMBLER, AMERICAN COACH, FLEETWOOD PRODIGY, AMERICAN EAGLE, NAVIGATOR, PULSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1144-2018·2018-03-28

    Merit Medical Recalls Custom Dialysis Kits with Incorrect Catheter Configuration

    Merit Medical Systems is recalling 44 custom dialysis kits because they contain 2-cuff catheters incorrectly configured and labeled as 1-cuff products.

    Product
    Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0933-2018·2018-03-28

    Weis Markets Recalls Penne With Asiago Sauce And Grilled Chicken Meal

    Weis Markets is recalling Penne W/Asiago Sauce And Grilled Chix Small Meal due to undeclared milk. The product was sold in seven states.

    Product
    Weis Sunbury, PA 17801; Penne W/Asiago Sauce And Grilled Chix Small Meal; multiple weight. SCALE UPC - 205377-00000
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1018-2018·2018-03-28

    Oregon Food Bank Recalls Roasted Pumpkin Seeds Due to Listeria

    Oregon Food Bank is recalling roasted pumpkin seeds because a Certificate of Analysis confirmed the presence of Listeria species.

    Product
    Roasted Pumpkin Seeds, packaged in 1 lbs. poly film bags with a twist type closure or in a re-sealable pouch, labeled as "distributed by Oregon Food Bank". Product was also distributed in packages labeled as Kale Joy brand.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0938-2018·2018-03-28

    ASR Group Recalls Sugar Syrup Due to Foreign Metal Material

    ASR Group International Inc. is recalling approximately 50,000 wet pounds of Tank Truck #2 Sugar Syrup because it may contain foreign metal material.

    Product
    Tank Truck #2 Sugar Syrup (403764)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1135-2018·2018-03-28

    Smiths Medical Medfusion Syringe Pumps Recalled for Syringe Misidentification

    Smiths Medical is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, preventing proper programming.

    Product
    Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2018·2018-03-28

    Centurion Medical Recalls Pediatric IV and IV Start Kits

    Centurion Medical Products Corporation is recalling Pediatric IV & IV Start Kits. The recall is classified as Class II by the FDA.

    Product
    PEDIATRIC IV & IV START KIT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1150-2018·2018-03-28

    Siemens AXIOM Artis angiographic x-ray systems recalled for coolant leaks

    Siemens is recalling 22 AXIOM Artis angiographic x-ray systems because leaking coolant couplings can damage the flat panel detector, potentially requiring treatment cancellation or patient transfer.

    Product
    AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patien
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1157-2018·2018-03-28

    Bovie J-Plasma Precise FLEX Recall for Incomplete Cable Seal

    Bovie Medical is recalling 12 units of the J-Plasma Precise FLEX due to a potential seal failure that could allow patient fluid backflow and cross-contamination.

    Product
    J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1139-2018·2018-03-28

    BD Vacutainer Tubes Recalled for Lead Test Inaccuracy

    Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.

    Product
    BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414); 6. 367844 (UDI: 50382903678445); 7. 367856 (UDI: 503829036
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-1136-2018·2018-03-28

    Smiths Medical Recalls Medfusion Syringe Pumps Due to Syringe Recognition Issues

    Smiths Medical is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, potentially preventing proper pump programming.

    Product
    Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0937-2018·2018-03-28

    ASR Group Recalls Sugar Syrup Due to Metal Foreign Material

    ASR Group International Inc. is recalling approximately 50,000 wet pounds of Tank Truck #1 Sugar Syrup because it may contain foreign metal material.

    Product
    Tank Truck #1 Sugar Syrup (403763)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1101-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage

    Boston Scientific is recalling Malecot Nephrostomy Catheter Sets because they are breaking at the mid-shaft bond during use.

    Product
    Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2018·2018-03-28

    Merit Medical Recalls Misconfigured Peritoneal Dialysis Catheters

    Merit Medical Systems is recalling 30 Flex-Neck Classic Peritoneal Dialysis Catheters because 2-cuff devices were incorrectly configured and labeled as 1-cuff products.

    Product
    Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1097-2018·2018-03-28

    Centurion Medical Products Recalls Wound Care Kits

    Centurion Medical Products Corporation is recalling Wound Care Kits due to a Class II medical device recall. The kits are intended to assist practitioners with IV placement and securement.

    Product
    WOUND CARE KIT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1132-2018·2018-03-28

    NxStage PureFlow B Solution Recalled for Missing Labeling Warnings

    NxStage Medical is recalling 1,243,400 units of PureFlow B Solution because the original labeling failed to warn against mixing dialysate formulations.

    Product
    NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2018·2018-03-28

    Beckman Coulter AutoMate Systems Recalled for Premature Belt Failure

    Beckman Coulter is recalling AutoMate 1200, 1250, 2500, and 2550 systems due to premature belt failure that poses a remote risk of cross-contamination.

    Product
    AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1138-2018·2018-03-28

    ESAOTE MyLab Ultrasound Systems Recalled for Probe Overheating Risk

    ESAOTE is recalling specific MyLab Ultrasound Systems because the probe head may overheat during use in certain settings.

    Product
    MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1134-2018·2018-03-28

    Medfusion Syringe Pumps Recalled for Syringe Misidentification Risk

    Smiths Medical ASD Inc. is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, potentially preventing proper pump programming.

    Product
    Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1153-2018·2018-03-28

    Bovie Medical Recalls J-Plasma Precise OPEN Devices Due to Seal Defect

    Bovie Medical is recalling 1,005 J-Plasma Precise OPEN units worldwide because a cable plug defect may cause an incomplete helium seal, risking cross-contamination.

    Product
    J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1156-2018·2018-03-28

    Bovie Medical Recalls J-Plasma Precise 360 Devices Due to Seal Defect

    Bovie Medical is recalling J-Plasma Precise 360 devices because a cable plug defect may allow patient fluid to backflow, creating a risk of cross-contamination.

    Product
    J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1151-2018·2018-03-28

    Beckman Coulter AutoMate 2500 Chemistry Analyzer Recall for Sensor Defect

    Beckman Coulter is recalling AutoMate 2550 and 1250 chemistry analyzers because a misaligned sensor may fail to detect missing pipette tips, posing a remote risk of cross-contamination.

    Product
    AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage

    Boston Scientific is recalling 422 units of Malecot Nephrostomy Catheters because they may break at the mid-shaft bond during use.

    Product
    Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collecting system while maintaining external access. The Stenting Malecot Nephrostomy C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1154-2018·2018-03-28

    Bovie Medical Recalls J-Plasma Precise Devices Due to Cross-Contamination Risk

    Bovie Medical is recalling J-Plasma Precise devices because a cable plug defect may allow patient fluid to backflow, creating a risk of cross-contamination.

    Product
    J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1130-2018·2018-03-28

    Situate Gauze Recalled for Potential Failure to Detect by Console

    Covidien LLC is voluntarily recalling Situate Gauze RF and X-Ray detectable products due to a manufacturing error that may prevent detection by the Situate console.

    Product
    Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device t
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0979-2018·2018-03-28

    Trader Joe's Peanut Butter Cookies Recalled Due to Mislabeling

    Food and Beverage Inc. is recalling Trader Joe's Peanut Butter Sutter's Formula Cookies because they were packed in Chocolate Chip Cookie bags, posing a peanut allergy risk.

    Product
    Name: Trader Joe s Chocolate Chip Cookies SKU 68075 Net Weight: 12 oz. (340g) Number of units per package: 16 cookies Package type: Kraft paper bag
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1091-2018·2018-03-28

    Centurion Medical Recalls Latex Free IV Start Sets

    Centurion Medical Products Corporation is recalling Latex Free IV Start Sets due to a Class II FDA recall. The products were distributed nationally.

    Product
    LATEX FREE IV START SET
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1102-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage

    Boston Scientific is recalling Re-Entry Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.

    Product
    Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography "
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2018·2018-03-28

    MedComp Catheter Repair Kit Recalled for Potential Connection Failures

    Medical Components, Inc. is recalling 315 Catheter Repair Kits due to potential connection failures that could cause blood loss or air emboli.

    Product
    CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0936-2018·2018-03-28

    Adams Reserve Fajita Grilling Rub Recalled for Undeclared Wheat

    Adams Extract & Spice LLC is recalling Adams Reserve Fajita Grilling Rub bottles due to undeclared wheat. The product was distributed in Texas.

    Product
    Adams Reserve, Fajita Grilling Rub 5.7 oz. Bottle Item Code: 04544, 12 bottles per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1120-2018·2018-03-28

    MedComp Recalls Tesio Catheter Sets Due to Connection Failure Risk

    Medical Components, Inc. is recalling 712 Tesio catheter sets because connection failures could cause blood loss or air emboli.

    Product
    12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2018·2018-03-28

    MedComp Recalls Tesio Catheter Sets Due to Connection Failure Risk

    Medical Components, Inc. is recalling 55 Tesio Catheter Sets because potential connection failures could lead to blood loss or air emboli.

    Product
    12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1146-2018·2018-03-28

    Vascular Insights Recalls ClariVein IC Infusion Catheters Due to Manufacturing Defect

    Vascular Insights is recalling 928 ClariVein IC infusion catheters because a manufacturing defect may cause the catheter shaft to delaminate.

    Product
    ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2018·2018-03-28

    Boston Scientific Recalls Re-Entry Malecot Nephrostomy Catheter Sets

    Boston Scientific is recalling specific Re-Entry Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.

    Product
    Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography "
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2018·2018-03-28

    Siemens Artis one Fluoroscopic X-Ray System Recalled for Table Defect

    Siemens is recalling 16 Artis one fluoroscopic x-ray systems because a missing or incorrect snap ring could cause the tabletop to slide to the floor.

    Product
    Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one include car
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Drugs)·D-0604-2018·2018-03-28

    Fresenius Recalls DELFLEX Peritoneal Dialysis Solution Due to Bag Leakage

    Fresenius Medical Care is recalling specific lots of DELFLEX Peritoneal Dialysis Solution because bag leakage may compromise sterility.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Food)·F-0935-2018·2018-03-28

    Weis Dried Beef Party Rye Dip Recalled for Undeclared Allergens

    Weis Markets is recalling Dried Beef Party Rye Dip because the label failed to list egg and milk, which are present in the ingredients.

    Product
    Dried Beef Party Rye Dip; Ingredients: Hellman's Mayonaise, Sour Cream, Dried Beef (Cured with Water, Salt, Sugar, Sodium Nitrate, Sodium Nitrite), Parsley, Onion, Dill Weed; SELL BY date up to 3/11/18
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1095-2018·2018-03-28

    Centurion Medical Recalls Neonatal IV Start Kits Due to Quality Concerns

    Centurion Medical Products Corporation is recalling specific lots of Neonatal IV Start Kits. The recall is a Class II action, indicating a potential risk of temporary or medically reversible health consequences.

    Product
    NEONATAL IV START KIT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1155-2018·2018-03-28

    Bovie Medical Recalls J-Plasma Handpieces Due to Incomplete Cable Seal

    Bovie Medical is recalling 5,416 J-Plasma handpieces worldwide because an incomplete cable seal could allow patient fluid backflow, creating a cross-contamination risk.

    Product
    J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1094-2018·2018-03-28

    Centurion Infant IV Securement Kit Recalled by FDA

    Centurion Medical Products Corporation is recalling Infant IV Securement Kits due to a Class II FDA recall. The kits are used to assist with IV placement and securement.

    Product
    INFANT IV SECUREMENT KIT
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1167-2018·2018-03-28

    Implant Direct Recalls Swish Tapered Implants Due to Packaging Error

    Implant Direct Sybron Manufacturing is recalling 1,117 Swish Tapered Implants because the packaged extender may be positioned upside down in the plastic retainer.

    Product
    SwishTapered Implant Intended for use in support for fixed bridgework.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1140-2018·2018-03-28

    BD Vacutainer Tubes Recalled for Lead Test Inaccuracy

    Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.

    Product
    BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-1163-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Safety Checklists

    Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required procedural notes and insertion checklists.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1152-2018·2018-03-28

    Arrow International Recalls ARROWg+ard Blue PLUS Catheters Due to Missing Lid Information

    Arrow International Inc is recalling 420 ARROWg+ard Blue PLUS catheters because certain lots may be missing lot numbers, expiration dates, and UDI information on the lid.

    Product
    ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against cat
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1166-2018·2018-03-28

    Arrow International Recalls Central Venous Catheter Kits Missing Safety Checklists

    Arrow International is recalling 18,124 central venous catheter kits because they lack required safety checklists and procedure notes.

    Product
    ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1080-2018·2018-03-28

    Centurion Medical Products Recalls General Purpose Instrument Trays

    Centurion Medical Products is recalling General Purpose Instrument Trays because a PVP Prep Pad in the kit does not meet required iodine levels for shelf life.

    Product
    GENERAL PURPOSE INSTRUMENT TRAY
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1145-2018·2018-03-28

    Merit Medical Recalls Misconfigured Infant Peritoneal Dialysis Catheter Kits

    Merit Medical Systems is recalling 8 dialysis kits containing misconfigured infant catheters. The 1-cuff catheters were incorrectly labeled as 2-cuff products.

    Product
    Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1149-2018·2018-03-28

    Medica Wash Kit Recalled for Inconsistent Lipase Test Results

    Medica Corporation is recalling Wash Kit REF 10680 because an ineffective wash solution causes inconsistent lipase test results.

    Product
    Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1087-2018·2018-03-28

    Centurion Minor Dressing Change Tray Recalled for Iodine Assay Failure

    Centurion Medical Products is recalling Minor Dressing Change Trays because a PVP Prep Pad component failed to meet required iodine assay levels for shelf life.

    Product
    MINOR DRESSING CHANGE TRAY
    Category
    Medical Device
    Distribution
    0 states

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