The Recall Desk

Archive

June 2018 recalls

577 recalls were announced in June 2018.

What the numbers show

Critical
17
Severe
142
High
282
Moderate
123
Low
13

Of the 577 recalls this month scored against our rubric, 3% are Critical, 25% are Severe.

401–500 of 577

  • HighUSDA FSIS·048-2018·2018-06-12

    J Bar B Foods Recalls Beef Sausage for Undeclared Pork Casing

    J Bar B Foods is recalling beef brisket smoked sausage products because they contain an undeclared pork casing, which may cause allergic reactions.

    Product
    J Bar B Foods — J Bar B Foods Recalls Beef Sausage Products due to Adulterated and Misbranded Ingredient
    Category
    Food
    Distribution
    1 state
  • HighCPSC·18177·2018-06-12

    Lorex Recalls Three Video Monitor Models Due to Battery Burn Hazard

    Lorex is recalling three video monitor models because the batteries can overheat and swell, posing a burn hazard. Consumers should stop using the monitors and contact Lorex for a refund.

    Product
    Lorex video monitors models LW2751, LW2752 and LW2962H
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V389000·2018-06-11

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

    Ford is recalling 2018 F-650 and F-750 trucks because brake hose fittings may lack anti-corrosion plating, risking fluid leaks and reduced braking.

    Product
    FORD — FORD F-750 SD, F-650 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V390000·2018-06-11

    Ford Recalls 2017-2018 Edge and 2017 Lincoln MKZ for Torque Converter Defect

    Ford is recalling 2017-2018 Edge and 2017 Lincoln MKZ vehicles because inadequate welding on the torque converter may cause the vehicle to lose the ability to move, increasing crash risk.

    Product
    FORD — FORD, LINCOLN EDGE, MKZ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V428000·2018-06-11

    BMW Recalls 2000-2006 Models for Passenger Air Bag Inflator Rupture Risk

    BMW is recalling specific 2000-2006 models because the passenger air bag inflator may rupture during deployment, potentially sending metal fragments into the cabin.

    Product
    BMW — BMW 325I, 325XI, M3, 330XI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V386000·2018-06-08

    Forest River Recalls 2019 Salem and Wildwood Trailers for Axle Defect

    Forest River is recalling 2019 Salem and Wildwood recreational trailers because an axle equalizer defect could cause axle failure and increase crash risk.

    Product
    FOREST RIVER — FOREST RIVER WILDWOOD, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·046-2018·2018-06-08

    Venda Ravioli Recalls Frozen Meat Ravioli Produced Without Federal Inspection

    Venda Ravioli, Inc. is recalling approximately 672 pounds of frozen meat ravioli products produced without the benefit of federal inspection. The products were distributed to retail locations in Massachusetts and Rhode Island.

    Product
    Venda Ravioli, Inc. Recalls Meat Ravioli Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·18V385000·2018-06-08

    Thor Motor Coach Recalls 2019 Motorhomes Due to Rear Axle Bolt Issue

    Thor Motor Coach is recalling 691 specific 2019 motorhome models because rear axle U-bolts may be insufficiently tightened, posing a risk of axle separation and loss of control.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH FREEDOM ELITE, OUTLAW, FOUR WINDS, VEGAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V387000·2018-06-08

    Newmar Recalls 2018-2019 Motorhomes Due to Windshield Wiper Defect

    Newmar is recalling 2018-2019 Essex, London Aire, King Aire, and Mountain Aire motorhomes because windshield wiper arms may not contact the glass, reducing visibility.

    Product
    NEWMAR — NEWMAR ESSEX, LONDON AIRE, KING AIRE, MOUNTAIN AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·047-2018·2018-06-08

    Tyson Recalls Breaded Chicken Tenderloins Due to Plastic Contamination

    Tyson Foods is recalling approximately 3,120 pounds of frozen breaded chicken tenderloins that may contain blue or clear soft plastic. The products were shipped to food service establishments nationwide.

    Product
    Tyson Foods Inc. Recalls Breaded Chicken Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·044-2018 Expansion·2018-06-07

    Supermercado Selectos Recalls Raw Frozen Fish and Meat Products

    Supermercado Selectos is recalling raw, frozen fish, beef, pork, and poultry products produced without federal inspection. No illnesses have been reported.

    Product
    Supermercado Selectos, San Sebasti†n, Recalls Raw, Frozen Siluriformes Fish, Meat and Poultry Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V384000·2018-06-07

    Spartan K2 and K3 Motorhome Chassis Recalled for Tire Damage Risk

    Spartan is recalling 2016-2019 K2 and K3 motorhome chassis because the tag axle tire may be damaged by the DEF fill bracket, increasing crash risk.

    Product
    SPARTAN — SPARTAN K3, K2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V381000·2018-06-07

    Ferrari Recalls 2012 Models Due to Passenger Air Bag Inflator Defect

    Ferrari is recalling 2012 California, 458, and FF models because the passenger air bag inflator may explode in a crash, potentially causing serious injury or death.

    Product
    FERRARI — FERRARI CALIFORNIA, FF, 458
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V376000·2018-06-07

    Forest River Recalls 2017-2018 Glaval Transit Buses for Seat Belt Defect

    Forest River is recalling 2017-2018 Glaval transit buses because a washer in the driver's seat belt assembly may break, allowing the belt to separate from the vehicle.

    Product
    GLAVAL BUS — GLAVAL BUS CONCORDE II, COMMUTE, TITAN II LOW FLOOR, UNIVERSAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V379000·2018-06-07

    Altec Recalls 2016-2017 Aerial Devices and Digger Derricks for Grounding Defect

    Altec is recalling 2016-2017 Aerial Devices and Digger Derricks because improperly sized cable connection receptacles may cause the high voltage grounding system to fail, increasing the risk of injury.

    Product
    ALTEC — ALTEC DIGGER DERRICK, AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V380000·2018-06-07

    Volkswagen Recalls 2018 Atlas Models for Seat Belt Buckle Damage Risk

    Volkswagen is recalling 54,729 2018 Atlas vehicles because missing manual information can lead to seat belt buckle damage, increasing injury risk in crashes.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V382000·2018-06-07

    Mobility Ventures Recalls MV-1 Vehicles for Turn Signal Defect

    Mobility Ventures is recalling 2015-2016 MV-1 vehicles because a failed rear turn signal does not alert the driver, increasing crash risk.

    Product
    MOBILITY VENTURES — MOBILITY VENTURES MV-1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0880-2018·2018-06-06

    FDA Recalls 7K Capsules Containing Undeclared Sildenafil and Tadalafil

    The FDA is recalling 7K capsules distributed by SX Power Co. because they contain undeclared sildenafil and tadalafil, making them unapproved drugs with unestablished safety and efficacy.

    Product
    7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0879-2018·2018-06-06

    Poseidon Platinum 4500 Recalled for Undeclared Sildenafil and Tadalafil

    Shoreside Enterprises Inc. is recalling Poseidon Xtreme PLATINUM 4500 because FDA analysis found undeclared sildenafil and tadalafil, making it an unapproved drug.

    Product
    POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2035-2018·2018-06-06

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Charging Failure

    Philips is recalling five HeartStart MRx monitor/defibrillators because a faulty circuit board may prevent charging, potentially delaying life-saving therapy.

    Product
    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2038-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device discontinuous or open.

    Product
    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d. Product Code LXC-15; e. Product Code LXC-16; f. Product Code LXC-17;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1928-2018·2018-06-06

    Maquet Datascope Recalls CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps

    Maquet Datascope is recalling CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps because fluid ingress can damage electronic circuit boards, preventing therapy initiation or continuation.

    Product
    CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
    Category
    Medical Device
    Distribution
    50 states
  • SevereNHTSA·18V373000·2018-06-06

    Northwood Recalls 2019 Nash Travel Trailers Due to Tire Rubbing

    Northwood is recalling 2019 Nash 24M and 29S travel trailers because tires may rub against shocks, causing damage and increasing crash risk.

    Product
    NORTHWOOD — NORTHWOOD NASH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2039-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device open or discontinuous.

    Product
    LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx only. Labeled as: a. Product Code LXMC-13; b. Product Code LXMC-14; c. Product Code LXMC-15; d. Product Code LXMC-16; e. Product Code LXMC-17; Laparoscopic, fu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V375000·2018-06-06

    Volkswagen Recalls 2018 Atlas and Tiguan for Passenger Air Bag Defect

    Volkswagen is recalling 2018 Atlas and Tiguan vehicles because the passenger frontal air bag may tear or fail to unfold properly in a crash, increasing injury risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN TIGUAN, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2048-2018·2018-06-06

    Ethicon HARMONIC ACE Shears Recalled for Inadvertent Activation Risk

    Ethicon Endo-Surgery Inc is recalling HARMONIC ACE Shears because an internal component may cause continuous or inadvertent activation of the device.

    Product
    HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal therma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2036-2018·2018-06-06

    Recall of Sterile Powdered Surgical Gloves Due to Banned Powder Content

    WRP Asia Pacific Sdn Bhd is recalling 201,000 pairs of AmerisourceBergen sterile surgical gloves because some left-handed gloves contain powder, which is banned in the U.S.

    Product
    AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1952-2018·2018-06-06

    Gyrus ACMI Reusable Active Cord Recalled for Fire Hazard

    Gyrus Acmi is recalling 6,447 reusable active cords for electrosurgical generators due to a potential risk of sparking and causing a fire.

    Product
    Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2041-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device open or discontinuous.

    Product
    LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: a. Product Code LXM-13; b. Product Code LXM-14; c. Product Code LXM-15; d. Product Code LXM-16; Laparoscopic, fundic-sparing anti-reflux procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1567-2018·2018-06-06

    Terry's Potato Salad Recalled for Potential Listeria Contamination

    Morski Brands Inc. is recalling Terry's Potato Salad due to potential Listeria monocytogenes contamination. The product was distributed in six states.

    Product
    Terry's Potato Salad, Packaged into the following sized containers: 1. Net Wt. 30 lbs. (13.68kg), Mfg No. 20117, UPC 10032345201177. 2. Net Wt. 5 lbs. (2.27Kg), Mfg. No. 21080, UPC 10032345190808 Keep Refrigerated between 35 - 38 F. MFG by Dawn's Foods, Portage, WI 5
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2006-2018·2018-06-06

    Arrow International Recalls Catheter Clamps Due to Sterility Risk

    Arrow International Inc is recalling 4Fr. Catheter Clamps with Fastener because unsealed packaging may compromise product sterility.

    Product
    4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1973-2018·2018-06-06

    Arrow Radial Artery Catheterization Kit Recalled for Packaging Defect

    Arrow International is recalling Radial Artery Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1521-2018·2018-06-06

    Chocolate Bar Recalled for Undeclared Wheat Allergen

    JJBL LLC is recalling The Most Awesome Chocolate Bar EVER due to undeclared wheat. The product was distributed in California, Oregon, and Washington.

    Product
    The Most Awesome Chocolate Bar EVER, packaged individually in a 1.5 oz bar. The UPC is 8 55966 00178 9. The label is read in parts: "***Lillie Belle Farms***The Most Awesome Chocolate Bar EVER! ***Ingredients: organic milk and dark chocolate (organic cocoa mass, organic cocoa
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1501-2018·2018-06-06

    Liberty Snacks Almond Raisin Mix Recalled for Listeria Risk

    Ohio Hickory Harvest is recalling Liberty Snacks Almond Raisin Mix due to Listeria monocytogenes found in a product stored in the same bin.

    Product
    Liberty Snacks NUTS ALMOND RAISIN Mix Net Wt. 1.6 oz (#g) DISTRIBUTED BY Liberty Candy & Nuts Inc. 347.945.0540 [email protected] UPC 8-04879-17158-7
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-1986-2018·2018-06-06

    Arrow International Recalls Percutaneous Sheath Introducer Kits Due to Sterility Concerns

    Arrow International Inc. is recalling 416,055 Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters; Product Codes: ASK-29803-SJH, ASK-29903-SJH, and ASK-29903-UW1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1948-2018·2018-06-06

    Respire Pink+ Oral Sleep Apnea Device Recalled for Breakage Risk

    Respire Medical is recalling 29 units of the Pink+ Hard/Soft Oral Sleep Apnea Device due to a potential for device breakage during use.

    Product
    Respire Pink+ Hard/Soft Oral Sleep Apnea Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1570-2018·2018-06-06

    Sully's Potato Salad Recalled for Potential Listeria Contamination

    Morski Brands Inc. is recalling Sully's Potato Salad due to potential Listeria monocytogenes contamination. The product was distributed in six states.

    Product
    Sully's Potato Salad, Mfg. No. 10125, Net Wt. 10 lbs. (4.54kg), UPC 10032345101255 Keep Refrigerated between 34 - 40 F. Mfg. By Dawn's Foods, Portage, WI 53901
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1500-2018·2018-06-06

    Liberty Snacks Raw Almonds Recalled for Listeria Risk

    Ohio Hickory Harvest is recalling Liberty Snacks Raw Almonds due to Listeria monocytogenes detected in a product stored in the same bin.

    Product
    Liberty Snacks Raw ALMONDS Net Wt. 1.3 oz (#g) DISTRIBUTED BY Liberty Candy & Nuts Inc. 347.945.0540 [email protected] UPC 8-04879-17157-7
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-1974-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Defect

    Arrow International is recalling 416,055 Single-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1949-2018·2018-06-06

    Respire Pink+ Hard Oral Sleep Apnea Device Recalled for Breakage Risk

    Respire Medical is recalling 25 units of the Pink+ Hard Oral Sleep Apnea Device due to a potential for device breakage during use.

    Product
    Respire Pink+ Hard Oral Sleep Apnea Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline is recalling sterile needle counters because packaging seal creep may compromise sterility. The product is used to count surgical sharps.

    Product
    MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·18170·2018-06-06

    GE Lighting Recalls LED Tube Lamps Due to Shock and Electrocution Hazards

    GE Lighting is recalling LED tube lamps sold at Lowe's because the pins can become energized during installation, posing electric shock and electrocution hazards.

    Product
    Cool White Universal T8/T12 LED tube lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1993-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Sterility Risk

    Arrow International Inc is recalling Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1499-2018·2018-06-06

    Liberty Snacks Honey Roasted Cashews Recalled for Listeria Risk

    Ohio Hickory Harvest is recalling Liberty Snacks Honey Roasted Cashews due to Listeria monocytogenes found in a product stored in the same bin.

    Product
    Liberty Snacks Honey Roasted CASHEWS Net Wt. 1.2 oz (#g) DISTRIBUTED BY Liberty Candy & Nuts Inc. 347.945.0540 [email protected] UPC 8-04879-17154-4
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-1970-2018·2018-06-06

    Arrow Radial Artery Catheterization Kits Recalled for Packaging Defects

    Arrow International is recalling Radial Artery Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1496-2018·2018-06-06

    Heinens Organic Nut Mix Recalled for Listeria Risk

    Heinens Organic Nut Mix is being recalled because a product in the same storage bin tested positive for Listeria monocytogenes.

    Product
    Heinens Organic Nut Mix Net Wt. 9 oz (255g) Distributed By Heinens, Warrensville Hts., OH 44128 UPC 0-36232-01871-1
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·F-1568-2018·2018-06-06

    Dawn's Foods Deluxe Potato Salad Recalled for Listeria Risk

    Morski Brands Inc. is recalling Dawn's Foods Deluxe Potato Salad due to potential Listeria monocytogenes contamination.

    Product
    Dawn's Foods Deluxe Potato Salad Mfg. No. 20114, Net Wt. 30 lbs. (13.68kg), UPC 10032345201146 Keep Refrigerated between 35 - 38 F. MFG by Dawn's Foods, Portage, WI 53901
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2008-2018·2018-06-06

    Arrow International Recalls Catheter Clamps Due to Sterility Risk

    Arrow International Inc is recalling 7Fr. Catheter Clamps with Fastener because unsealed packaging may compromise product sterility.

    Product
    7Fr. Catheter Clamp with Fastener; Product Code: CC-00007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2018·2018-06-06

    Arrow Multi-Lumen Central Venous Catheterization Kit Recalled for Packaging Defect

    Arrow International is recalling specific lots of ARROWg+ard Blue PLUS catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1989-2018·2018-06-06

    Arrow International Recalls Pressure Injectable CVC Kits Due to Sterility Concerns

    Arrow International is recalling 416,055 ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2018·2018-06-06

    Arrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Concerns

    Arrow International is recalling specific lots of Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2018·2018-06-06

    Arrow International Recalls Multi-Lumen CVC Kits Due to Packaging Issues

    Arrow International is recalling specific lots of ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kits because unsealed packaging may compromise sterility.

    Product
    ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1938-2018·2018-06-06

    Ad-Tech Medical Recalls Disposable Drill Kits Due to Potential Component Mix-Up

    Ad-Tech Medical Instrument Corporation is recalling 30 sterile Disposable Drill Kits because they may contain drill bits from the wrong catalog number.

    Product
    Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a ste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2018·2018-06-06

    Arrow International Extension Line Slide Clamps Recalled for Sterility Concerns

    Arrow International is recalling Extension Line Slide Clamps because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 34 other countries.

    Product
    Extension Line Slide Clamps; Product codes: SA-09847
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2018·2018-06-06

    Arrow International Recalls Two-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 two-lumen central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802-DMC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2018·2018-06-06

    Respire Pink H/S Oral Sleep Apnea Device Recalled for Breakage Risk

    Respire Medical is recalling the Respire Pink H/S Oral Sleep Apnea Device due to a potential for device breakage during use.

    Product
    Respire Pink H/S Oral Sleep Apnea Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2023-2018·2018-06-06

    Arrow PICC Sets Recalled Due to Potential Sterility Compromise

    Arrow International Inc is recalling 416,055 PICC sets because unsealed packaging may have compromised product sterility.

    Product
    ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2027-2018·2018-06-06

    Arrow International Recalls VPS Rhythm ECG Accessory Packs Due to Sterility Concerns

    Arrow International Inc is recalling VPS Rhythm ECG Accessory Packs because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 35 other countries.

    Product
    VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2018·2018-06-06

    Medical Action Industries Recalls Blue OR Towels Due to Sterility Concerns

    Medical Action Industries is recalling 31,440 Blue OR Towels because their sterility may be compromised. The towels were distributed to seven US states and Canada.

    Product
    Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This OR towel product is intended for external use only. These towels are intended to be used as absorbent towels for hand drying, cleanup, and to provide increase
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2015-2018·2018-06-06

    Arrow JACC IV Catheters Recalled Due to Potential Sterility Compromise

    Arrow International Inc. is recalling 416,055 ARROW JACC IV catheters because unsealed packaging may have compromised product sterility.

    Product
    ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2037-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Sutures

    Torax Medical is recalling LINX Reflux Management System implant sutures because a manufacturing defect may cause beads to separate from wire links, potentially rendering the device discontinuous.

    Product
    LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS-12; b. Product Code LS-13; c. Product Code LS-14; d. Product Code LS-15; e. Product Code LS-16; f. Product Code LS-17; Lap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2018·2018-06-06

    Arrow International Recalls Sheath Adapters Due to Compromised Sterility

    Arrow International is recalling Sheath Adapters with Cath-Gard shields because unsealed packaging may compromise product sterility.

    Product
    Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1983-2018·2018-06-06

    Arrow International Recalls MAC Two-Lumen Central Venous Access Kits

    Arrow International Inc is recalling MAC Two-Lumen Central Venous Access Kits because unsealed packaging may compromise product sterility.

    Product
    MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP and ASK-21242-PR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1978-2018·2018-06-06

    Arrow International Recalls Two-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 Two-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2031-2018·2018-06-06

    Arrow PSI Kit Recall Due to Potential Sterility Compromise

    Arrow International is recalling 416,055 PSI kits because unsealed packaging may have compromised sterility. The recall covers products distributed in the US and 34 other countries.

    Product
    ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2010-2018·2018-06-06

    Arrow International Recalls Clear Fenestrated Drapes Due to Packaging Issues

    Arrow International Inc is recalling 416,055 Clear Fenestrated Drapes with Adhesive because unsealed packaging may compromise product sterility.

    Product
    Clear Fenestrated Drape with Adhesive; Product Code: CD-00001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2025-2018·2018-06-06

    Arrow PICC Catheters Recalled Due to Potential Sterility Compromise

    Arrow International Inc. is recalling 416,055 PICC catheters because unsealed packaging may have compromised product sterility.

    Product
    Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2018-2018·2018-06-06

    Arrow International Recalls Multi-Lumen CVC Kits Due to Sterility Concerns

    Arrow International Inc is recalling 416,055 ARROWgard Blue PLUS Multi-Lumen CVC Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter; Product Code: MSO-45703-AHS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1937-2018·2018-06-06

    Maquet Recalls VOLISTA StandOP Surgical Lights Due to Keypad Failure Risk

    Maquet SAS is recalling 187 VOLISTA StandOP surgical lights because the keypads may fail. The units were distributed worldwide from October 2012 to June 2017.

    Product
    VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1980-2018·2018-06-06

    Arrow International Recalls Multi-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 Pressure Injectable Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2018·2018-06-06

    Arrow Central Venous Catheterization Kit Recalled for Unsealed Packaging

    Arrow International Inc. is recalling ARROWg+ard Blue Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2018·2018-06-06

    Arrow International Recalls Continuous Nerve Block Needles Due to Packaging Defect

    Arrow International is recalling 416,055 continuous nerve block needles because unsealed packaging may compromise product sterility.

    Product
    Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1962-2018·2018-06-06

    Arrow International Recalls SnapLock Catheter/Syringe Adapters Due to Packaging Defect

    Arrow International is recalling SnapLock Catheter/Syringe Adapters because unsealed packaging may compromise sterility. The recall affects 416,055 units distributed in the US and 34 other countries.

    Product
    SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2016-2018·2018-06-06

    Arrow International Recalls 10 cc Luer-Slip Loss of Resistance Syringes

    Arrow International Inc is recalling 10 cc Luer-Slip Loss of Resistance Syringes because unsealed packaging may compromise product sterility.

    Product
    10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1991-2018·2018-06-06

    Arrow Central Venous Catheter Kits Recalled for Packaging Defect

    Arrow International is recalling 416,055 central venous catheter kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM and ASK-42854-PRR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2018·2018-06-06

    Arrow International Recalls Spring-Wire Guide Introducer Catheter Assemblies

    Arrow International Inc is recalling 416,055 Spring-Wire Guide Introducer Catheter Assemblies because the packaging may be unsealed, potentially compromising product sterility.

    Product
    Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1945-2018·2018-06-06

    Olsen Medical Recalls Symmetry Monopolar Forceps Due to Sterile Seal Risk

    Olsen Medical is recalling 4,110 Symmetry monopolar forceps worldwide because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF 20-
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1981-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 Pressure Injectable Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2018·2018-06-06

    Arrow International Recalls PICC Catheter Trimmers Due to Packaging Defects

    Arrow International is recalling 416,055 PICC Catheter Trimmers because unsealed packaging may compromise product sterility. The recall covers units distributed in the US and 34 other countries.

    Product
    PICC Catheter Trimmer ; Product Code:PC-00001-T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1498-2018·2018-06-06

    Liberty Snacks Natural Pistachios Recalled for Listeria Risk

    Ohio Hickory Harvest is recalling Liberty Snacks Natural Pistachios because a product in the same storage bin tested positive for Listeria monocytogenes.

    Product
    Liberty Snacks Natural PISTACHIOS Net Wt. 1 oz (#g) DISTRIBUTED BY Liberty Candy & Nuts Inc. 347.945.0540 [email protected] UPC 8-04879-17158-4
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-2000-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Sterility Concerns

    Arrow International Inc is recalling 416,055 ARROWg+ard Blue PLUS Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline is recalling Sterile Needle Counters because packaging seal creep may compromise sterility. The recall covers 38,464 units distributed in the US, Canada, and other countries.

    Product
    MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2012-2018·2018-06-06

    Arrow TheraCath Epidural Catheters Recalled for Unsealed Packaging

    Arrow International is recalling TheraCath Epidural Catheters because unsealed packaging may compromise sterility. The recall covers 416,055 units distributed in the US and 33 other countries.

    Product
    TheraCath(R) Epidural Catheter; Product Code: EC-05000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1956-2018·2018-06-06

    Roche MagNA Pure 24 System Recalled for Sample Cross-Contamination

    Roche Molecular Systems is recalling 163 MagNA Pure 24 automated clinical sample extractors due to reported cross-contamination of samples during rack-based purification runs.

    Product
    MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2018·2018-06-06

    Arrow Arterial Catheterization Kit Recalled for Unsealed Packaging

    Arrow International Inc. is recalling Arterial Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Arterial Catheterization Kit; Product Code:NA-04550-1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2042-2018·2018-06-06

    NordicNeuroLab Recalls nordicTumorEx 1.0 Software Due to Image Orientation Errors

    NordicNeuroLab AS is recalling 16 licenses of nordicTumorEx 1.0 software because a DICOM header error may cause incorrect image orientation labeling.

    Product
    nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2018·2018-06-06

    Arrow Arterial Catheterization Kits Recalled for Unsealed Packaging

    Arrow International is recalling 416,055 Arterial Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Arterial Catheterization Kit; Product Codes: ASK-04020-DH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1963-2018·2018-06-06

    Arrow Maximal Barrier Drape Recalled for Unsealed Packaging

    Arrow International Inc. is recalling 416,055 Maximal Barrier Drapes because unsealed packaging may compromise product sterility.

    Product
    Maximal Barrier Drape; Product Codes: ASK-00001-1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2005-2018·2018-06-06

    Arrow International Recalls Triple-Lumen CVC Kits Due to Packaging Defect

    Arrow International is recalling 416,055 ARROWgard Blue PLUS Triple-Lumen CVC Kits because unsealed packaging may compromise sterility.

    Product
    ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2018·2018-06-06

    Arrow-Flex Percutaneous Sheath Introducer Kit Recalled for Packaging Defect

    Arrow International Inc. is recalling Arrow-Flex Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2018.