The Recall Desk

Archive

June 2019 recalls

686 recalls were announced in June 2019.

What the numbers show

Critical
12
Severe
191
High
347
Moderate
123
Low
13

Of the 686 recalls this month scored against our rubric, 2% are Critical, 28% are Severe.

401–500 of 686

  • HighNHTSA·19V439000·2019-06-11

    Ford Transit Recall: Modified Glass Roof Hatches May Shatter

    LA West is recalling 2018-2019 Ford Transit vehicles with modified glass roof hatches that may shatter due to stress, posing an injury risk.

    Product
    FORD — FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V428000·2019-06-11

    Unicell Recalls ASA Voyager Monitors on Commercial Vehicles

    Unicell is recalling 325 commercial vehicles equipped with ASA Electronics Voyager monitors that may display reversed back-up camera images, increasing crash risk.

    Product
    CHEVROLET — CHEVROLET, RAM, ISUZU EXPRESS, PROMASTER, NPR, 155
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V438000·2019-06-11

    2019 Jeep Renegade Recall for Air Bag Calibration Defect

    Chrysler is recalling 2019 Jeep Renegade vehicles with the Upland trim package because the occupant restraint controller may be miscalibrated, increasing injury risk in crashes.

    Product
    JEEP — JEEP RENEGADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V441000·2019-06-11

    Godwin Recalls 2017 Dump Bodies Due to Brake Light Wiring Defect

    Godwin is recalling 2017 dump bodies equipped with Whelen brake lights that may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    GODWIN — GODWIN DUMP BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19752·2019-06-11

    Amazon Recalls AmazonBasics Ceramic Space Heaters Due to Fire and Burn Hazards

    Amazon is recalling AmazonBasics 1500 Watt Ceramic Space Heaters because they can overheat, posing fire and burn hazards. Consumers should stop using the heaters and contact Amazon for a full refund.

    Product
    AmazonBasics 1500 Watt Ceramic Space Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V432000·2019-06-10

    Ford Recalls Econoline Vehicles Due to Transmission Weld Failure Risk

    Ford is recalling 2009-2016 Econoline vehicles with specific transmissions and emergency packages due to a weld defect that may cause sudden loss of drive power.

    Product
    FORD — FORD ECONOLINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V433000·2019-06-10

    Ford Recalls 2013 F-150s for Transmission Downshifting Risk

    Ford is recalling 2013 F-150 trucks with 5.0L or 6.2L engines previously repaired under recall 19V-075 because the transmission may unexpectedly downshift into first gear, increasing crash risk.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·067-2019·2019-06-09

    Taylor Farms Recalls Bacon Quiche for Undeclared Egg Allergen

    Taylor Farms Illinois is recalling 51 pounds of Jarlsberg and bacon quiche because the label failed to list eggs, a known allergen.

    Product
    Taylor Farms Illinois, Inc — Taylor Farms Illinois, Inc. Recalls Bacon Quiche Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    8 states
  • SevereNHTSA·19V431000·2019-06-08

    Farber Specialty Vehicles Recalls 2018 XCR Models Due to Brake Bolt Issue

    Farber Specialty Vehicles is recalling 2018 XCR specialty vehicles because brake caliper mounting bolts may not be sufficiently tightened, which can reduce brake effectiveness and increase crash risk.

    Product
    FCCC — FCCC XCR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V425000·2019-06-07

    Mazda Recalls 2019 Mazda3 Vehicles Due to Loose Lug Nuts

    Mazda is recalling 2019 Mazda3 vehicles because lug nuts may loosen, potentially causing a wheel to detach and increasing crash risk.

    Product
    MAZDA — MAZDA MAZDA3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·066-2019·2019-06-07

    Tyson Recalls Chicken Fritters Due to Possible Hard Plastic Contamination

    Tyson Foods is recalling approximately 190,757 pounds of ready-to-eat chicken fritters that may contain hard plastic. The products were shipped to institutional foodservice locations nationwide.

    Product
    Tyson Foods, Inc. — Tyson Foods, Inc. Recalls Ready-To-Eat Chicken Fritter Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·19V429000·2019-06-07

    Mickey Truck Bodies Recalls 2017-2018 Ford F-750 Vehicles

    Mickey Truck Bodies is recalling 2017-2018 Ford F-750 vehicles because back-up camera monitors may revert to factory settings, causing the image to reverse and increasing crash risk.

    Product
    FORD — FORD F-750
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V426000·2019-06-07

    Newmar Recalls Motorhomes Due to Rear Light Malfunction Risk

    Newmar is recalling specific 2016-2019 motorhomes because a damaged power module may cause rear lights to fail, increasing crash risk.

    Product
    NEWMAR — NEWMAR MOUNTAIN AIRE, DUTCH STAR, ESSEX, VENTANA LE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V430000·2019-06-07

    Morgan Olson P31 Recalled for Reversed Backup Camera Image

    Morgan Olson is recalling 2018 P31 vehicles because backup camera monitors may revert to factory settings, causing the image to reverse and increasing crash risk.

    Product
    MORGAN OLSON — MORGAN OLSON P31
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·065-2019·2019-06-06

    Table 87 Frozen Recalls Pork Pizza Produced Without Federal Inspection

    Table 87 Frozen, LLC is recalling approximately 649 pounds of frozen prosciutto pizzas produced without federal inspection. No adverse reactions have been reported.

    Product
    Table 87 Frozen, LLC — Table 87 Frozen, LLC Recalls Pork Pizza Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V424000·2019-06-06

    Acura Recalls 2016-2019 ILX Vehicles for Driveshaft Separation Risk

    Acura is recalling 2016-2019 ILX vehicles because excessive grease may prevent a set-ring from engaging, allowing the driveshaft to separate and increase crash risk.

    Product
    ACURA — ACURA ILX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V422000·2019-06-06

    2020 International HV Trucks Recalled for Wheel Bearing Lubrication Defect

    Navistar is recalling 2020 International HV Severe Service Diesel Trucks because insufficient steer axle hub lubrication may cause wheel bearing damage and potential wheel separation.

    Product
    INTERNATIONAL — INTERNATIONAL HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V419000·2019-06-06

    Diamond Coach VIP 2800 Recalled for Reversed Backup Camera Image

    Diamond Coach is recalling one 2017 VIP 2800 vehicle because the backup camera display may revert to factory settings, causing the image to reverse and increasing crash risk.

    Product
    DIAMOND COACH — DIAMOND COACH VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V421000·2019-06-06

    Land Rover Recalls 2020 Range Rover Evoque for Washer Fuse Failure

    Jaguar Land Rover is recalling 2020 Range Rover Evoque vehicles because a fuse failure may reduce driver visibility, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER EVOQUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V423000·2019-06-06

    SkyMark Recalls 2018 Flowmark Vacuum Trucks Due to Monitor Defect

    SkyMark Refuelers is recalling 2018 Flowmark Vacuum Trucks because the back-up camera monitors may revert to factory settings, reversing the image and increasing crash risk.

    Product
    FLOWMARK — FLOWMARK VACUUM TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1321-2019·2019-06-05

    Stiff Boy LLC Recalls The Beast Due to Undeclared Sildenafil

    Stiff Boy LLC is recalling The Beast because FDA analysis found undeclared sildenafil. The product was marketed without an approved NDA or ANDA.

    Product
    The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1443-2019·2019-06-05

    Laxmi Brand Dried Apricots Recalled for Undeclared Sulfites

    House of Spices India, Inc. is recalling Laxmi Brand Dried Apricots because the product contains elevated levels of undeclared sulfites.

    Product
    Laxmi Brand Dried Apricot 7 oz (200g) Plastic Pouch UPC Code: 2324617054
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1429-2019·2019-06-05

    Suja Organic Kombucha Recalled Due to Glass Fragments

    Suja Life LLC is recalling 64,896 bottles of Organic Kombucha - Ginger Lemon due to consumer complaints of finding pieces of glass in the product.

    Product
    Suja Organic Kombucha - Ginger Lemon: 15.2 oz. glass bottle; UPC 818617020232 DISTRIBUTED BY SUJA LIFE, LLC OCEANSIDE, CA 92056 CERTIFIED ORGANIC BY CCOF SUJAJUICE.COM
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Devices)·Z-1511-2019·2019-06-05

    Maquet Getinge-BEQ-TOP Circulatory Circuits Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Maquet Getinge-BEQ-TOP 15704 Circulatory Circuits because a design feature may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1526-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1669-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (2) Material: 701067370R02 BO-TOP 38803 OPEN HEART PACK W (3) Material: 701067370R03 BO-TOP 38803 OPEN HEART PACK W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1670-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1426-2019·2019-06-05

    Biltmore Smoked Salmon Recalled Due to Listeria Monocytogenes Contamination

    Seven Seas International USA LLC is recalling Biltmore Sashimi Grade Smoked Wild Sockeye Salmon because the product tested positive for Listeria monocytogenes.

    Product
    Biltmore, Sashimi Grade Smoked Wild Sockeye All Natural Alaskan Salmon, 4 oz. (113g)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1574-2019·2019-06-05

    Maquet Getinge ECC Pump Packs Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC Pump Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK Material: 701065770
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1537-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1575-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 46500 PRIME PACK Material:701065823
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1573-2019·2019-06-05

    Maquet Getinge Adult ECC Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.

    Product
    Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1547-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Getinge-BEQ-TOP 38900 ECC Packs because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1521-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 25500 ECC Tubing Sets Recalled for Sterility Assurance Issues

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because the design may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1544-2019·2019-06-05

    Maquet Getinge-T 8028 Pressure Pigtail Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Pressure Pigtail devices because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.

    Product
    Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1507-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 5900 Custom Tubing Sets Recalled for Sterility Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1660-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-T 5211 ECC Large Children's Hospital Material: 701064560R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1666-2019·2019-06-05

    Maquet Getinge NICU ECC Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling NICU ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 39202 NICU ECC PACK Material: 701067313R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1430-2019·2019-06-05

    Suja Organic Kombucha Recalled Due to Glass Fragments

    Suja Life LLC is recalling 90,489 bottles of Organic Kombucha - Peach Ginger because consumers reported finding pieces of glass in the product.

    Product
    Suja Organic Kombucha - Peach Ginger: 15.2 oz. glass bottle; UPC 818617020348 DISTRIBUTED BY SUJA LIFE, LLC OCEANSIDE, CA 92056 CERTIFIED ORGANIC BY CCOF SUJAJUICE.COM
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Devices)·Z-1638-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1637-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 5900 TCH 3/8 Quadrox-iD Pack Material:701050228R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1652-2019·2019-06-05

    Maquet Getinge E-Circuit Bioline Heparin Tubing Sets Recalled for Sterility Concerns

    Maquet Cardiovascular is recalling specific batches of BEQ-TOP 37200 E-Circuit Bioline Heparin tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin Material: 701055388R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1633-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8 Material:701049440R02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1308-2019·2019-06-05

    Avella Recalls Bevacizumab Prefilled Syringes Due to Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 730 prefilled syringes of Bevacizumab 2.5 mg/0.1 mL due to a lack of assurance of sterility.

    Product
    Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416 N. 19TH AVENUE PHOENIX, AZ 85085, NDC 42852-001-27
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1515-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1536-2019·2019-06-05

    Maquet Getinge-T Sample Manifold Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Sample Manifolds because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.

    Product
    Maquet Getinge-T 22706 SAMPLE MANIFOLD Material:701054912
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1519-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1615-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1376-2019·2019-06-05

    Terumo Portico Solo Re-Collapsible Access System Recalled for Tip Dislodgement

    Terumo Medical Corporation is recalling Portico Solo Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially causing injury.

    Product
    Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1427-2019·2019-06-05

    Global Pride Rattan Shoots Recalled for Undeclared Sulfites

    U.S. Tov, Inc. is recalling Global Pride Rattan Shoots in Brine because testing found high levels of undeclared sulfites.

    Product
    Global Pride Rattan Shoots in Brine: 24 oz. glass jar UPC: 8855273023148 Erawan Enterprise Co. Ltd Bangkok, Thailand. Ingredients: Rattan 50.6%, Water 48.9%, Citric Acid (E330) 0.5%
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Devices)·Z-1687-2019·2019-06-05

    Abbott MitraClip XTR Clip Delivery System Recalled for Malfunction

    Abbott Vascular is recalling the MitraClip XTR Clip Delivery System because clips may open or become nonfunctional during implantation, requiring additional surgery.

    Product
    Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1649-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow.

    Product
    Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack Material:701054438R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1569-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" Material: 701065504
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1555-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization gas flow.

    Product
    Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 8068 1/4" WITH BRIDGE Material: 701066883
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1659-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of BO-TOP 48400 OR PACK tubing sets because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1375-2019·2019-06-05

    Terumo SOLOPATH Re-Collapsible Access System Recalled for Tip Dislodgement Risk

    Terumo Medical Corporation is recalling 1,431 SOLOPATH Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially compromising the device's smooth transition.

    Product
    SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1439-2019·2019-06-05

    Wegman's Neptune Salad Recalled for Undeclared Milk Allergen

    Wegmans Food Markets is recalling Neptune Salad containers because old labels failed to declare the milk allergen.

    Product
    Wegman's Neptune Salad 1 lb containers, UPC Begins with 2010883100000, Model/catalog # 13081
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1374-2019·2019-06-05

    Terumo Recalls SoloPath Balloon Expandable TransFemoral Systems Due to Tip Dislodgement Risk

    Terumo Medical Corporation is recalling 2,228 SoloPath Balloon Expandable TransFemoral Systems because the device tip may dislodge from the sheath, potentially causing vessel trauma.

    Product
    SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 Product Usage: The SoloPath Balloon Expandable TransFemoral Introducer System (STFI) a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1641-2019·2019-06-05

    Maquet Neonate ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific neonate extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 28601 NEONATE ECC QPiD Material: 701051935R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1556-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Getinge-BEQ-T 5211 Large ECC Sets because a design feature may prevent proper sterilization.

    Product
    Maquet Getinge-BEQ-T 5211 LARGE ECC SET Material:701064560
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1423-2019·2019-06-05

    Paximadi Plain Biscotti Recalled for Undeclared Milk Allergen

    Paximadi Co. LLC is recalling Plain Biscotti because the label declares butter but fails to declare milk, a common allergen.

    Product
    Biscotti-Plain. Product is bulk packed in a master cardboard case and each master case contains either 48 or 36 individual biscotti. There are 12 Biscotti per layer and separated between layers with wax paper. Label applied to the exterior of master case only. The master ca
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1601-2019·2019-06-05

    Maquet Getinge Adult ECC Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.

    Product
    Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1596-2019·2019-06-05

    Maquet Pediatric Cardiac Surgery Packs Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Pediatric Cardiac Surgery Packs because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1626-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because the stopcock design may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC Material: 709000516
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1646-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32 & HMOD Material:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1545-2019·2019-06-05

    Maquet Getinge-T 8029 Pressure Pigtail Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Pressure Pigtail devices because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1608-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material: 709000266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V417000·2019-06-05

    Thor Motor Coach Recalls 2019-2020 Magnitude and Omni Motorhomes for Fire Risk

    Thor Motor Coach is recalling 2019-2020 Magnitude and Omni motorhomes because wires in the electrical junction box may contact an extra screw, increasing the risk of an electrical short circuit and fire.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH MAGNITUDE, OMNI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2019·2019-06-05

    Maquet Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific pediatric extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1679-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization.

    Product
    Maquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2019·2019-06-05

    Maquet Getinge Cardioplegia Packs Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Cardioplegia Packs because a design feature may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-T 4963 CARDIOPLEGIA PACK Material: 701067203
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1612-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1495-2019·2019-06-05

    ThermaCare HeatWraps Recalled for Potential Skin Burn Risk

    PF Consumer Healthcare is recalling ThermaCare HeatWraps because some units may produce higher-than-specified temperatures, posing a risk of skin burns or blisters.

    Product
    ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1587-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 15705 Material: 701051122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1682-2019·2019-06-05

    Teleflex Medical Recalls RUSCH LASERTUBE Due to Laser Guard Foil Separation

    Teleflex Medical is recalling 1,787 units of RUSCH LASERTUBE (Rubber) because the laser guard foil partially separated or detached at the edges.

    Product
    RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material:701047962R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all parts of the fluid path.

    Product
    Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 8208#3/8 inch ECC Pack Material: 701068798
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1604-2019·2019-06-05

    Maquet Getinge Cardioplegia Packs Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Getinge-BO-T 52360 Cardioplegia Packs because a design feature may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P Material:701066366
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1505-2019·2019-06-05

    Maquet Small Patient Tubing Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Small Patient Tubing Packs because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack Material: 701049994
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2019·2019-06-05

    Maquet Getinge Neonatal Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific neonatal tubing sets because a design feature may prevent sterilization gas from reaching all parts, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1566-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because the stopcock design may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992
    Category
    Medical Device
    Distribution
    Distributed nationwide

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