The Recall Desk

Archive

July 2020 recalls

590 recalls were announced in July 2020.

What the numbers show

Critical
11
Severe
159
High
329
Moderate
75
Low
16

Of the 590 recalls this month scored against our rubric, 2% are Critical, 27% are Severe.

Which agencies issued them

401–500 of 590

  • LowFDA (Drugs)·D-1377-2020·2020-07-15

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Peak

    VistaPharm is recalling Nystatin Oral Suspension cups because an impurity peak exceeded approved specifications. The recall covers 380,700 cups distributed in the United States and Puerto Rico.

    Product
    Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1374-2020·2020-07-15

    Somerset Therapeutics Recalls Brimonidine Tartrate Ophthalmic Solution

    Somerset Therapeutics is recalling Brimonidine Tartrate Ophthalmic Solution 0.2% due to a slow leaching process from the product label that may impact the product over its shelf life.

    Product
    BRIMONIDINE TARTRATE — BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V406000·2020-07-14

    Setra Motorcoaches Recalled for Electronic Stability Control Defect

    Daimler Coaches North America is recalling 2018-2020 Setra motorcoaches because the Electronic Stability Control system can be disabled at unsafe speeds, increasing crash risk.

    Product
    SETRA — SETRA S417 TC, S407 CC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V405000·2020-07-14

    Jayco Recalls 2016-2018 Motorhomes Due to Leveling System Bracket Failure

    Jayco is recalling specific 2016-2018 motorhomes because a mounting bracket for the leveling system may fail, allowing components to contact the ground and increasing crash risk.

    Product
    JAYCO — JAYCO REDHAWK, GREYHAWK, ENVOY 200, ENVOY 100
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E048000·2020-07-13

    Curt Rambler RV Towbars Recalled for Axial Pivot Pin Failure Risk

    Curt Manufacturing is recalling Rambler RV Towbars because the axial pivot pin may loosen or fail, potentially causing the hitch to separate and increasing crash risk.

    Product
    TRAILER HITCHES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V403000·2020-07-13

    Mitsubishi Outlander Recall: Second-Row Seat Belt Buckle Interference

    Mitsubishi is recalling 2014-2019 Outlander and 2018-2019 Outlander PHEV vehicles because the second-row center seat belt buckle may interfere with the right-side buckle, rendering it inoperable.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER PHEV, OUTLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V400000·2020-07-10

    Forest River Recalls 2021 Riverstone Trailers Due to Wiring Defect

    Forest River is recalling specific 2021 Riverstone trailers equipped with an optional generator prep package due to incorrect transfer switch wiring that may cause voltage back feed.

    Product
    FOREST RIVER — FOREST RIVER RIVERSTONE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20759·2020-07-09

    Ananda Apothecary Recalls Essential Oils Due to Non-Child-Resistant Packaging

    Ananda Apothecary is recalling four essential oil products because their packaging is not child-resistant, posing a risk of poisoning if swallowed by young children.

    Product
    Wintergreen 100% Pure Essential Oil, Sweet Birch 100% Pure Essential Oil, Super Soother Pure Essential Oil Blend, and Breathe Deep Pure Essential Oil Blend
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20761·2020-07-09

    RH Recalls Riveted Mesh Floor Lamps Due to Fire Hazard

    RH is recalling Riveted Mesh Floor Lamps because the foot switch can overheat or catch fire. Consumers should stop using the lamps and contact RH for a refund.

    Product
    Riveted Mesh Floor Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1009-2020·2020-07-08

    Hill Country Fare Fruit Punch Drink Recalled for Undeclared Milk

    He Butt is recalling Hill Country Fare Fruit Punch Drink because it may contain undeclared milk. Consumers should check their bottles and return them to the store.

    Product
    Hill Country Fare Fruit Punch Drink 1 GAL CONT. NET. 3.78L Contains < 1% Juice UPC 4122005172
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1007-2020·2020-07-08

    Hill Country Fare Pink Lemon Drink Recalled for Undeclared Milk

    Hill Country Fare Pink Lemon Drink is being recalled because it may contain undeclared milk. Consumers should stop using the product.

    Product
    Hill Country Fare Pink Lemon Drink 1 GAL CONT. NET. 3.78L Contains < 1% Juice UPC 4122005174
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1015-2020·2020-07-08

    Mount Franklin Foods Recalls 7-Select Yogurt Pretzels for Undeclared Peanuts

    Mount Franklin Foods is recalling 7-Select Yogurt Pretzels because they may contain undeclared peanuts. The product was distributed to 7-11 stores nationwide.

    Product
    7-Select Yogurt Pretzels Naturally Flavored Vanilla Crunchy Pretzel Covered in a Vanilla Yogurt NET WT 5 OZ (142 g) UPC 5254856657
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1010-2020·2020-07-08

    Hill Country Fare Grape Drink Recalled for Potential Undeclared Milk

    The FDA is recalling Hill Country Fare Grape Drink because it may contain undeclared milk, a major food allergen.

    Product
    Hill Country Fare Grape Drink 1 GAL CONT. NET. 3.78L Contains < 1% Juice UPC 4122005176
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1027-2020·2020-07-08

    Enlightened Dairy-Free Chocolate Peanut Butter Frozen Dessert Recalled for Undeclared Milk

    Beyond Better Foods is recalling Enlightened Dairy-Free Chocolate Peanut Butter Frozen Dessert because it may contain undeclared milk.

    Product
    Enlightened Dairy-Free Chocolate Peanut Butter Frozen Dessert, one Pint (473 ml). Case GTIN: 1-08-52109-33106-9. Item UPC:8-52109-33150-5. Produced exclusively for: Beyond Better Foods, LLC, Bronx, NY
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2451-2020·2020-07-08

    LivaNova Recalls Sterile Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 600 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-2415-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Component Failure

    Arrow International Inc is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component issue that may cause the device to stop working.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1358-2020·2020-07-08

    Koala Hand Sanitizer Recalled for Subpotent Ethanol and Undeclared Isopropyl Alcohol

    Beaming White LLC is recalling Koala Hand Sanitizer because the active ingredient ethanol was tested below the label claim and undeclared isopropyl alcohol was present.

    Product
    Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2439-2020·2020-07-08

    LivaNova SCP Pump Control Panel Recalled for Rotary Knob Wear

    LivaNova is recalling eight SCP Pump Control Panels because premature wear of the angle encoder may make the rotary knob difficult or impossible to rotate during cardiopulmonary bypass.

    Product
    Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-1359-2020·2020-07-08

    Koala Hand Sanitizer Recalled for Subpotent Ethanol and Undeclared Isopropyl Alcohol

    Beaming White LLC is recalling Koala Hand Sanitizer because the ethanol content is below the label claim and undeclared isopropyl alcohol is present.

    Product
    Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V399000·2020-07-08

    Kia Recalls 2020 Sedona Vehicles Due to Alternator Fire Risk

    Kia is recalling 2020 Sedona vehicles because a loose alternator terminal nut may cause electrical arcing and increase the risk of a fire.

    Product
    KIA — KIA SEDONA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2408-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail, causing the device to stop working or fail to start.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2413-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International Inc is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component vibration issue that may cause the device to stop working.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2440-2020·2020-07-08

    LivaNova SCP Pump Control Panel Recalled Due to Rotary Knob Wear

    LivaNova is recalling 24 SCP Pump Control Panels because the rotary knob may fail to rotate due to premature wear, risking patient injury during surgery.

    Product
    Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Food)·F-1019-2020·2020-07-08

    Trident Seafoods Recalls Imitation Crab Supreme Due to Undeclared Egg

    Trident Seafoods is recalling Gordon Choice Imitation Crab Supreme Style because the product may contain undeclared egg white.

    Product
    Gordon Choice Imitation Crab Supreme Style, Net Wt 40 oz (2 lb 8 oz) Keep Frozen. UPC 93901-71212. For Distribution exclusively by Gordon Food Service Wyoming, MI 49509
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1357-2020·2020-07-08

    Koala Hand Sanitizer Recalled for Subpotent Alcohol and Undeclared Ingredients

    Beaming White LLC is recalling Koala Hand Sanitizer because the ethanol level is below the label claim and it contains undeclared isopropyl alcohol.

    Product
    Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2411-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Component Vibration Failure

    Arrow International Inc. is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component vibration issue may cause the device to stop working or fail to start.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1008-2020·2020-07-08

    Hill Country Fare Citrus Punch Drink Recalled for Undeclared Milk

    Hill Country Fare Citrus Punch Drink is being recalled due to potential undeclared milk, posing a risk to consumers with milk allergies.

    Product
    Hill Country Fare Citrus Punch Drink 1 GAL CONT. NET. 3.78L Contains 0% Juice UPC 4122081863
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2463-2020·2020-07-08

    LivaNova Recalls Vein Irrigation Cannulas Due to Sterile Barrier Breach

    LivaNova USA Inc. is recalling 150 units of Vein Irrigation Cannulas with blunt tips because internal tests identified potential breaches in the sterile barrier.

    Product
    Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-2412-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International is recalling AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1364-2020·2020-07-08

    Preferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets Due to NDMA

    Preferred Pharmaceuticals is recalling 144 bottles of Metformin HCl Extended Release Tablets, 500 mg, because FDA analysis detected N-Nitrosodimethylamine (NDMA) levels exceeding the Acceptable Daily Intake Limit.

    Product
    Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2455-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Drugs)·D-1360-2020·2020-07-08

    Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    The Harvard Drug Group is recalling Metformin Hydrochloride Extended-Release Tablets due to potential NDMA impurity levels above established limits.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1363-2020·2020-07-08

    MasterPharm Recalls Compounded Minoxidil, Biotin, and Spironolactone Capsules

    MasterPharm LLC is recalling compounded Minoxidil/Biotin/Spironolactone capsules due to elevated levels of minoxidil and biotin. The product was distributed in Florida and Maryland.

    Product
    Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale, Store at room temperature, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Food)·F-1014-2020·2020-07-08

    Brill Frozen Cookie Dough Recalled for Undeclared Walnuts

    Brill Inc. is recalling 252 cases of frozen cookie dough because the product may contain undeclared walnuts, a major food allergen.

    Product
    Brill 30 lb. cases of 480 1.0 oz. chocolate chip with mini colored candy pieces frozen cookie dough, MDM # 10194626, Manufactured by Brill, Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-07082020-01·2020-07-08

    BrucePac Recalls Diced Chicken Products Due to Undeclared Soy Allergen

    BrucePac issued a public health alert for ready-to-eat diced chicken products distributed in Fort Worth, Texas, due to potential cross-contamination with soy, an undeclared allergen.

    Product
    BrucePac — FSIS Issues Public Health Alert for Ready-To-Eat Diced Chicken Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·20E047000·2020-07-08

    TAP Recalls Rubicon Express Suspension Lift Kits for Jeep Gladiator

    TAP Worldwide is recalling certain Rubicon Express suspension lift kits for 2020-2021 Jeep Gladiators because the fitment guide inaccurately lists 40-inch tires as compatible, which can affect vehicle stability.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2417-2020·2020-07-08

    Arrow AC3 Optimus Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International Inc is recalling AC3 Optimus Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working or fail to start.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·20145·2020-07-08

    GloryBee Wintergreen Essential Oil Recalled for Packaging Defect

    GloryBee Natural Sweeteners is recalling Wintergreen Essential Oil because the packaging is not child-resistant, posing a risk of poisoning to young children.

    Product
    GloryBee Wintergreen Essential Oil
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2472-2020·2020-07-08

    United Imaging uCT 530 CT System Recalled for Scanning Interruptions

    Shanghai United Imaging Healthcare is recalling four uCT 530 Computed Tomography X-Ray Systems in Texas due to software issues that may cause scanning interruptions or image artifacts.

    Product
    uCT 530 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2437-2020·2020-07-08

    Siemens CentraLink Software Recalled for Potential Erroneous Patient Results

    Siemens Healthcare Diagnostics is recalling CentraLink Data Management System software versions 16.0.2 and 16.0.3 due to a defect that may cause erroneous patient results.

    Product
    (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolida
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2479-2020·2020-07-08

    Preventice BodyGuardian Heart Remote Monitoring Kit Recalled for Data Accuracy Issues

    Preventice Services is recalling eight BodyGuardian Heart Remote Monitoring Kits because unvalidated software may cause inaccurate data collection, making patient reports unreliable for condition evaluation.

    Product
    BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests identified potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 / 00803622123184
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2442-2020·2020-07-08

    Elekta Leksell Vantage Stereotactic System Recall for Locking Mechanism Defect

    Elekta is recalling 51 Leksell Vantage Stereotactic Systems because the locking mechanism at the Instrument Carrier and Arc interface may not function properly.

    Product
    Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2458-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 20 units of Sterile Standalone Connectors because internal tests identified potential breaches in the sterile barrier.

    Product
    1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2468-2020·2020-07-08

    Radiometer ABL80-FLEX CO-OX Box Label Recall for Barcode Misinterpretation

    Radiometer Medical ApS is recalling ABL80-FLEX CO-OX box labels because barcode misinterpretation on analyzers may cause patient mix-ups or delayed treatment.

    Product
    ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2469-2020·2020-07-08

    Siemens IMMULITE 2000 Analyzer Recalled for Tubing Crack Hazard

    Siemens Healthcare Diagnostics is recalling 1,555 IMMULITE 2000 analyzers because flexible tubing can crack, causing liquid waste leaks and slip hazards.

    Product
    Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2447-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile standalone connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2456-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 768 units of Sterile Disposable Connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2454-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 744 units of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2457-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 240 units of Sterile Disposable Connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2449-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 648 units of Sterile Disposable Connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Food)·F-1013-2020·2020-07-08

    Flagstone Foods Recalls Caramel Trail Mix for Unlabeled Cashews

    Flagstone Foods is recalling Sweet & Salty Caramel Trail Mix because it contains cashews that are not listed in the ingredient statement.

    Product
    NORTH STAR TRADING COMPANY SWEET & SALTY CARAMEL TRAIL MIX NET WT 14OZ (396g) MANUFACTURED FOR YOUR MILITARY EXCHANGES BY FLAGSTONE FOODS, INC. SAINT PAUL, MN 55102 UPC 0 80948 63064 4
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-2450-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 96 units of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2453-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2452-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 96 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2470-2020·2020-07-08

    Siemens IMMULITE 2000 XPi Analyzer Recalled for Tubing Crack Risk

    Siemens Healthcare Diagnostics Inc. is recalling 2,925 IMMULITE 2000 XPi Immunoassay Systems because flexible tubing can crack, causing liquid waste leaks and slip hazards.

    Product
    Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2446-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2464-2020·2020-07-08

    LivaNova Recalls Vein Irrigation Cannulas Due to Sterile Barrier Breach

    LivaNova is recalling 325 Vein Irrigation Cannulas because internal tests found potential breaches in the sterile barrier, which could compromise sterility.

    Product
    Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2445-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2467-2020·2020-07-08

    Radiometer ABL80-FLEX Box Label Recall for Barcode Misinterpretation Risk

    Radiometer Medical ApS is recalling ABL80-FLEX box labels because barcode misinterpretation on analyzers may cause patient mix-ups or delayed treatment.

    Product
    ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1012-2020·2020-07-08

    Toufayan Bakeries Smart Pockets Recalled for Undeclared Sesame and Poppy Seeds

    Toufayan Bakeries is recalling Smart Pockets Everything 6 Count packages due to undeclared sesame seeds, poppy seeds, and dehydrated garlic.

    Product
    TOUFAYAN BAKERIES SMART POCKETS EVERYTHING 6 COUNT NET WT 7.4 OZ. (210 g), UPC 0 7312400792 7. 12 packages per case. Product expiration date or shelf life date is not added to package by firm but may be added by retail store. According to the recalling firm, shelf life is approxi
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2416-2020·2020-07-08

    Arrow AC3 Optimus Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International is recalling AC3 Optimus Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2410-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International Inc. is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working or fail to start.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2414-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International Inc. is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component issue that may cause the device to stop working.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2441-2020·2020-07-08

    Mediana Attendant Vital Signs Monitor Recalled for Temperature Measurement Failures

    Mediana Co., Ltd. is recalling 180 Attendant Vital Signs Monitors because failures were found in the temperature measurement function while in predict mode.

    Product
    DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2409-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail, causing the device to stop working or fail to start.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1011-2020·2020-07-08

    Simply Nature Sweet Potato Bites Recalled for Foreign Object Risk

    Dr. Praeger's is recalling Simply Nature Sweet Potato Bites because the product may contain a foreign object. Consumers should check their pantries for the specific lot code.

    Product
    Simply Nature Sweet Potato Bites, 12oz retail boxes variety pack, Expiration date 4/9/2022. Lot code R20AJ-01A.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-2448-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2475-2020·2020-07-08

    Mueller Hybrid Wraparound Knee Support Recalled for Latex Mislabeling

    Mueller Sports Medicine is recalling Hybrid Wraparound Knee Supports because they contain natural rubber despite being labeled as latex-free.

    Product
    Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2433-2020·2020-07-08

    Codan Swan-Lock Needlefree Connectors Recalled for Potential Sterility Compromise

    Codan US Corporation is recalling 34,776 units of Swan-Lock Swabable Needlefree Connectors because individual packages may have incomplete or bad seals that could compromise sterility.

    Product
    CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on the label is CODAN US CORPORATION, Santa Ana, CA.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2474-2020·2020-07-08

    Baxter GEM Flow Coupler Monitor Recalled for Firmware Shutdown Issue

    Baxter Healthcare is recalling 60 units of the GEM Flow Coupler Monitor because a firmware issue may cause intermittent shutdowns when WiFi is not connected.

    Product
    Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2459-2020·2020-07-08

    LivaNova Recalls 220 Units of 3/8 Inch Y Connectors

    LivaNova USA Inc. is voluntarily recalling 220 units of 3/8 inch Y connectors due to a Class II defect.

    Product
    3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2461-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 420 units of sterile standalone connectors because internal tests identified potential breaches in the sterile barrier.

    Product
    1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2460-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 860 units of Sterile Standalone Connectors because internal tests identified a potential breach in the sterile barrier.

    Product
    3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2473-2020·2020-07-08

    Elekta Unity Radiation Therapy System Recalled for Heating Issues

    Elekta, Inc. is recalling 21 Unity Image-Guided Radiation Therapy Systems due to reports of excessive heating in the MRL Gradient Connection Module.

    Product
    Elekta Unity, Image-Guided Radiation Therapy System
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2471-2020·2020-07-08

    Fujifilm Synapse PACS Software Recalled for Incorrect Orientation Markers

    Fujifilm is recalling Synapse PACS Software versions 5.5.x and 5.7.x because incorrect orientation markers and slice locations may lead to misdiagnosis.

    Product
    Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 240 units of sterile standalone connectors because internal tests found potential breaches in the sterile barrier.

    Product
    1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2438-2020·2020-07-08

    Siemens Atellica Data Manager Software Recalled for Potential Erroneous Patient Results

    Siemens Healthcare Diagnostics is recalling Atellica Data Manager software versions 1.0 and 1.1 because unexpected interface driver behavior may cause quality control results to be assigned to incorrect control lot numbers, potentially leading to the reporting of erroneous patient results.

    Product
    (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory information modules which consolidate test orders and test resu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2443-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 120 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-2480-2020·2020-07-08

    Ortho VITROS 3600 Software Recall for Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System software versions 3.3.3 and below because MicroWell Qualitative Assay parameters may reset to defaults.

    Product
    VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2483-2020·2020-07-08

    Ortho VITROS 5600 System Recall for Software Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling 130 refurbished VITROS 5600 Integrated Systems because software modifications to assay parameters may be inadvertently reset to default.

    Product
    VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2434-2020·2020-07-08

    Westmed Recalls Neo-Vent Infant T-Piece Resuscitation Circuits Due to Fit Issues

    Westmed, Inc. is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a manufacturing error resulted in non-compliant 15mm OD connections, preventing use with compatible infant resuscitators.

    Product
    Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2477-2020·2020-07-08

    Ortho Organizers Recalls Mislabeled Maestro Orthodontic Brackets

    Ortho Organizers is recalling Maestro Orthodontic Brackets due to mislabeling. The recall affects 104 packages distributed to US and international consignees.

    Product
    Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2466-2020·2020-07-08

    ROi CPS LLC Recalls Respirator Crash Cart Kits Due to Labeling Error

    ROi CPS LLC is recalling 200 Respirator Crash Cart Kits because the kits are labeled with an expiration date later than the soonest component to expire.

    Product
    Respirator Crash Cart Kit
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2436-2020·2020-07-08

    Westmed Neo-Vent Infant T-Piece Resuscitation Circuit Recall for Non-Compliant Connections

    Westmed is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a mold repair resulted in non-compliant 15mm OD connections, preventing use with compatible infant resuscitators.

    Product
    Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2482-2020·2020-07-08

    Ortho VITROS 5600 Software Recall for Parameter Reset Defect

    Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.3 and below because assay parameters may reset to defaults.

    Product
    VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2435-2020·2020-07-08

    Westmed Recalls Neo-Vent Infant T-Piece Resuscitation Circuits Due to Fit Issues

    Westmed, Inc. is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a mold repair resulted in non-compliant 15mm OD connections that prevent use with compatible infant resuscitators.

    Product
    Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2020.