The Recall Desk

Archive

August 2021 recalls

482 recalls were announced in August 2021.

What the numbers show

Critical
11
Severe
122
High
293
Moderate
54
Low
2

Of the 482 recalls this month scored against our rubric, 2% are Critical, 25% are Severe.

1–100 of 482

  • SevereNHTSA·21V678000·2021-08-31

    Husqvarna FE 350S and FE 501S Motorcycles Recalled for Brake Defect

    KTM is recalling 2022 Husqvarna FE 350S and FE 501S motorcycles because incorrectly mounted brake pad clips may cause loose front brake pads, reducing braking performance.

    Product
    HUSQVARNA — HUSQVARNA FE 350S, FE 501S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V677000·2021-08-31

    Power Steering Pump Defect in 2021 Autocar Xpeditor Vehicles

    Autocar is recalling 2021 Xpeditor and certain 2020-2021 Legend vehicles due to a power steering pump defect that can cause loss of power steering assist and increase crash risk.

    Product
    AUTOCAR — AUTOCAR LEGEND, XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V676000·2021-08-31

    Utility Trailer Recalls 2022 VS2RA Models for Roof Sealer Plate Defect

    Utility Trailer is recalling 2022 VS2RA trailers because incorrect tape on the top foil may cause the sealer plate to separate from the roof, creating a road hazard.

    Product
    UTILITY — UTILITY UTILITY TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E082000·2021-08-30

    Takata Recalls Non-Azide Driver-Side Air Bag Inflators for Explosion Risk

    Takata is recalling specific non-azide driver-side air bag inflators that may absorb moisture, potentially causing the inflator to explode or the air bag to underinflate during deployment.

    Product
    AIR BAGS:FRONTAL:DRIVER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V673000·2021-08-30

    Triple E RV Recalls 2020-2021 Unity and Wonder Models for Fire Risk

    Triple E RV is recalling 550 Unity and Wonder vehicles because a 12-volt wire near the refrigerator exhaust could melt and cause a fire.

    Product
    TRIPLE E RV — TRIPLE E RV, TRIPLE E WONDER, UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V675000·2021-08-30

    2021 Subaru Impreza recalled for suspension control arm failures

    Subaru is recalling 2021 Impreza vehicles because the left-front lower control arm weld may fail, causing the arm to separate. This could result in loss of vehicle control and increased crash risk.

    Product
    SUBARU — SUBARU IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V674000·2021-08-30

    Vermeer Recalls 2021 Brush Chippers Due to Discharge Chute Separation Risk

    Vermeer is recalling 2021 BC900XL, BC1000XL, and BC1200XL brush chippers because the discharge chute may separate and fall off the trailer, creating a road hazard.

    Product
    VERMEER — VERMEER BC1200XL, BC900XL, BC1000XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·030-2021·2021-08-27

    Fratelli Beretta Recalls Uncured Antipasto Meat Due to Salmonella Risk

    Fratelli Beretta USA is recalling approximately 862,000 pounds of ready-to-eat uncured antipasto meat products due to possible Salmonella contamination.

    Product
    Fratelli Beretta USA, Inc. — Fratelli Beretta USA, Inc. Recalls Ready-to-Eat Uncured Antipasto Meat Products Due to Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·21V670000·2021-08-27

    KZRV recreational vehicles recalled for faulty propane regulators

    KZRV is recalling 2018-2022 recreational vehicles with defective Winntec propane regulators that may fail and increase pressure, raising the risk of fire.

    Product
    KZRV — KZRV DURANGO 1500, CAMPLITE, CONFLUENCE, CONNECT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V671000·2021-08-27

    2021 Airstream RVs Recalled for Propane Regulator Failure Fire Risk

    Airstream is recalling certain 2021 recreational vehicles with propane regulator defects that can increase pressure and enlarge flames in gas appliances, creating a fire risk. Dealers will replace the regulator and test the system at no cost.

    Product
    AIRSTREAM — AIRSTREAM FLYING CLOUD, GLOBETROTTER, BAMBI, INTERNATIONAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V669000·2021-08-27

    Boise Mobile Equipment Recalls One Fire Truck for Excessively Bright Lights

    Boise Mobile Equipment is recalling one 2016 Type 3 fire truck because its LED lights may be too bright, potentially affecting other drivers' vision and increasing crash risk.

    Product
    BOISE MOBILE EQUIPMENT — BOISE MOBILE EQUIPMENT TYPE 3 FIRE TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V663000·2021-08-26

    Coach House Platinum II recreational vehicle window adhesive failure recall

    Coach House is recalling 2019-2022 Platinum II and 2022 Platinum recreational vehicles due to window adhesive failure. The adhesive bonding the window vent may fail, potentially causing detachment and increasing crash or injury risk.

    Product
    COACH HOUSE — COACH HOUSE PLATINUM II, PLATINUM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V666000·2021-08-26

    Escape Trailer Recalls 2019 Models Due to Window Adhesive Failure

    Escape Trailer is recalling 2019 recreational trailers because window adhesive may fail, causing the vent to detach and increasing crash risk.

    Product
    ESCAPE — ESCAPE E21NE, E17B, E21C, E5.0
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V662000·2021-08-26

    Space Craft Recalls 2019-2021 Trailers Due to Window Adhesive Failure

    Space Craft is recalling 2019-2021 travel, fifth-wheel, and semi-trailers because window vent adhesive may fail, posing a crash or injury risk.

    Product
    SPACE CRAFT — SPACE CRAFT TRAVEL TRAILER, SEMI TRAILER, FIFTH WHEEL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V667000·2021-08-26

    Jaguar Recalls F-Pace, XF, and F-Type for Seat Belt Retractions

    Jaguar is recalling 2020-2022 F-Pace, XF, and F-Type vehicles because seat belt retractors may deactivate early, preventing child restraints from securing properly.

    Product
    JAGUAR — JAGUAR F-TYPE, F-PACE, XF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V668000·2021-08-26

    Land Rover seat belt retractor defect affects child restraint security

    Land Rover is recalling certain 2020-2022 vehicles because the seat belt automatic locking retractors may deactivate early, preventing child restraint systems from securing properly. This can increase the risk of injury during a crash.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER VELAR, DISCOVERY, DISCOVERY SPORT, RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V665000·2021-08-26

    2020 Jeep Wrangler Recalled for Fuel Line Fire Risk

    Chrysler is recalling 2020 Jeep Wrangler vehicles with 2.0-liter engines because a cracked fuel supply line connector may leak fuel, increasing fire risk.

    Product
    JEEP — JEEP WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V664000·2021-08-26

    2021 Dodge Challenger Safety System Status Indicators May Not Illuminate Properly

    2021 Dodge Challenger vehicles may not properly illuminate safety system status indicators in daylight or nighttime conditions. This could prevent drivers from knowing the status of vehicle safety systems, increasing crash risk.

    Product
    DODGE — DODGE CHALLENGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·21777·2021-08-26

    Ryan and Rose Cutie Spoovel Children's Eating Utensils Choking Hazard Recall

    Ryan and Rose is recalling Cutie Spoovel children's eating utensils because the handle can break off when bitten, releasing small parts that pose a choking hazard to young children. No injuries or choking incidents have been reported.

    Product
    Cutie Spoovel children's eating utensils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0874-2021·2021-08-25

    BBQ Seasoning Recalled Due to Salmonella Contamination

    Mane Inc is recalling BBQ seasoning products because an ingredient tested positive for Salmonella. The recall affects seasoning distributed to manufacturers in Ohio, Indiana, Minnesota, and Oregon.

    Product
    BBQ Seasoning Packaged in 50lb poly bag/cardboard box combo and kraft paper bags
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2244-2021·2021-08-25

    Argyle UVC Insertion Tray Recalled for Safety Scalpel Locking Defect

    Cardinal Health's Argyle UVC Insertion Tray, used for neonatal umbilical catheter insertion, lacks proper instructions for the included Safety Scalpel N11. Once locked, clinicians cannot unlock it, potentially delaying critical treatment.

    Product
    Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0734-2021·2021-08-25

    Idarubicin Hydrochloride Injection Recalled Due to Sterility Concerns

    Teva Pharmaceuticals USA is recalling Idarubicin Hydrochloride Injection 20 mg/20 mL vials nationwide due to lack of assurance of sterility. The recall affects 2,091 vials distributed across the United States and Puerto Rico.

    Product
    Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V661000·2021-08-25

    2022 Thomas Built Buses Minotour Recalled for Weak Side Panel Joints

    Daimler Trucks North America is recalling 2022 Thomas Built Buses Minotour school buses because adhesive may not have been properly applied, resulting in insufficient joint strength.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E080000·2021-08-25

    Joyson Recalls Curtain Air Bag Inflators Due to Rupture Risk

    Key Safety Systems (DBA Joyson) is recalling specific HPH-A curtain air bag inflators because moisture-induced corrosion can cause the inflator to rupture, potentially sending fragments into the vehicle cabin.

    Product
    AIR BAGS:SIDE/WINDOW:CURTAIN:INFLATOR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0741-2021·2021-08-25

    Metoclopramide Injection Vials Recalled for Lack of Sterility Assurance

    Teva Pharmaceuticals USA is recalling 25,653 vials of Metoclopramide Injection USP due to lack of assurance of sterility. The affected vials were distributed nationwide, including Puerto Rico.

    Product
    METOCLOPRAMIDE — METOCLOPRAMIDE (METOCLOPRAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V658000·2021-08-25

    Summit Trailer Recalls One 2017 AD45 for Steering Arm Defect

    Summit Trailer Sales is recalling one 2017 AD45 trailer because the steering arm may detach, potentially causing loss of steering control or a road hazard.

    Product
    SUMMIT — SUMMIT AD45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0738-2021·2021-08-25

    Teva Epoprostenol Sodium for Injection Recalled for Sterility Assurance

    Teva Pharmaceuticals USA is recalling Epoprostenol Sodium for Injection (1.5 mg/vial, 10 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0739-2021·2021-08-25

    Teva Norepinephrine Bitartrate Injection Recalled for Sterility Assurance

    Teva Pharmaceuticals USA is recalling Norepinephrine Bitartrate Injection, USP 4 mg/4 mL vials due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E079000·2021-08-25

    Rigid Hitch Recalls Specific Tow Hitches Due to Weld Defects

    Rigid Hitch is recalling certain DHB-series tow hitches because incorrect welding settings may cause the weld to fail, increasing the risk of a crash.

    Product
    STRUCTURE:BODY:TAILGATE:HINGE AND ATTACHMENTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0923-2021·2021-08-25

    Lebenswert Folgemilch Stage 3 Organic Toddler Formula Recalled

    Able Groupe Inc is recalling Lebenswert Folgemilch Stage 3 Organic Toddler Formula because required FDA pre-market notifications were not submitted and the product lacks mandatory labeling in English as required by federal regulations.

    Product
    Lebenswert Folgemilch Stage 3 Organic Toddler Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0732-2021·2021-08-25

    Haloperidol Decanoate Injection recalled due to sterility concerns

    Teva Pharmaceuticals USA is recalling Haloperidol Decanoate Injection 100 mg/mL due to lack of assurance of sterility. The recall affects 16,226 vials distributed nationwide, including Puerto Rico.

    Product
    Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V660000·2021-08-25

    Thomas Built Buses Saf-T-Liner HDX Recalled for Power Steering Hose Fire Risk

    Daimler Trucks North America is recalling 2016-2021 Thomas Built Buses Saf-T-Liner HDX transit buses because the power steering hose may be routed with inadequate clearance, potentially causing damage and increasing fire risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0916-2021·2021-08-25

    Holle Bio Stage 1 Organic Infant Formula Recall for Inadequate Iron Content and Labeling

    Able Groupe Inc is recalling Holle Bio Stage 1 Organic Infant Milk Formula because the product may contain insufficient iron for some infants and lacks required FDA labeling statements. The recall affects approximately 76,000 units sold directly through littlebundle.com.

    Product
    Holle Bio Stage 1 Organic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0875-2021·2021-08-25

    Sweet & Smoky BBQ Seasoning Recalled for Salmonella

    Mane Inc is recalling Sweet & Smoky BBQ seasoning packaged in 50lb kraft paper bags because an ingredient tested positive for Salmonella. The affected product was distributed to manufacturers in Ohio, Indiana, Minnesota, and Oregon.

    Product
    SWEET & SMOKY BBQ Packaged in 50lb kraft paper bags
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0737-2021·2021-08-25

    Leucovorin Calcium Injection Recalled Due to Sterility Concerns

    Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product meets sterility standards.

    Product
    Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0914-2021·2021-08-25

    HiPP German Stage 1 Infant Formula Lacks FDA Pre-Market Notification

    Able Groupe Inc is recalling HiPP German Stage 1 Combiotic Infant Milk Formula because required FDA pre-market notifications were not submitted. Some units contain inadequate iron levels and lack required English labeling.

    Product
    HiPP German Stage 1 Combiotic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0921-2021·2021-08-25

    Lebenswert Anfangsmilch Stage 1 Infant Formula Recall for Inadequate Iron and Labeling

    Able Groupe Inc is recalling Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula because some products contain insufficient iron and lack required FDA labeling. The formula may not provide adequate iron for certain infants, including premature infants and those with low birth weight.

    Product
    Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0911-2021·2021-08-25

    HiPP Dutch Stage 2 Infant Formula Missing Pre-Market Approval and Labeling

    Able Groupe Inc is recalling HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula because required pre-market notifications were not submitted to the FDA and products lack mandatory English labeling statements.

    Product
    HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0926-2021·2021-08-25

    Kendamil Organic Stage 1 Infant Formula Recalled for Missing FDA Notifications

    Able Groupe Inc is recalling Kendamil Organic Stage 1 First Infant Milk Formula because required pre-market FDA notifications were not submitted and the product lacks mandatory English labeling statements.

    Product
    Kendamil Organic Stage 1 First Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0873-2021·2021-08-25

    Bacon Ranch Seasoning Recalled for Salmonella Contamination

    Mane Inc is recalling Flavored Bacon Ranch Seasoning packaged in 25lb kraft paper bags due to Salmonella detected in an ingredient used during manufacturing. The affected product was distributed to manufacturers in Ohio, Indiana, Minnesota, and Oregon.

    Product
    Flavored Bacon Ranch Seasoning Packaged in 25lb kraft paper bags
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0922-2021·2021-08-25

    Lebenswert Stage 2 Infant Formula Recalled for Missing Labeling

    Able Groupe Inc is recalling Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula (76,000 units) sold directly through littlebundle.com. The formula was not submitted for required FDA pre-market notification and lacks mandatory English-language labeling.

    Product
    Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0918-2021·2021-08-25

    Holle Bio Stage 2 Organic Infant Formula Lacks Required FDA Pre-Market Notification

    Able Groupe Inc is recalling Holle Bio Stage 2 Organic Follow-On Infant Milk Formula because required FDA pre-market notifications were not submitted and the product lacks mandatory labeling in English required by federal regulations.

    Product
    Holle Bio Stage 2 Organic Follow-On Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0733-2021·2021-08-25

    Amikacin Sulfate Injection Recalled Due to Sterility Assurance Failure

    Teva Pharmaceuticals USA is recalling Amikacin Sulfate Injection USP 1 gram/4mL vials nationwide due to lack of assurance of sterility. The recall affects 4,712 vials with lot #31329243B and expiration date 05/2022.

    Product
    Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0735-2021·2021-08-25

    Teva Vecuronium Bromide Injection Recalled for Sterility Assurance

    Teva Pharmaceuticals USA is recalling Vecuronium Bromide for Injection 10 mg vials nationwide due to lack of assurance of sterility. The recall affects 62,358 vials distributed across multiple lots.

    Product
    Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0872-2021·2021-08-25

    Ballreich Barbeque Marcelled Potato Chips Salmonella Contamination Recall

    Ballreich Snack Food Company is recalling Barbeque Marcelled Potato Chips in 1.5, 2.5, and 7 ounce packages due to possible Salmonella contamination from an ingredient. The affected products were distributed in Indiana, Michigan, and Ohio.

    Product
    Barbeque Marcelled Potato Chips Ballreich Snack Food Company 1.5, 2.5, and 7 ounce flexible plastic packaging 1.5 ounce/72 case, 2.75 ounce 32/case, 7 ounce 14/case
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0907-2021·2021-08-25

    HiPP Comfort Milk Formula Recalled for Inadequate Iron and Labeling Violations

    Able Groupe Inc is recalling HiPP Comfort Milk Formula because some products contain insufficient iron and lack required labeling. The formula may not provide adequate iron for certain infants, particularly premature or low-birth-weight infants.

    Product
    HiPP Comfort Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0753-2021·2021-08-25

    Carvedilol Tablets Recalled for Foreign Paroxetine Tablets

    Zydus Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide after Paroxetine tablets were found mixed into bottles. Patients should not take affected bottles and contact their pharmacy or doctor.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0925-2021·2021-08-25

    HiPP UK Stage 2 Infant Formula Recalled for Missing FDA Notifications and Improper Labeling

    Able Groupe Inc is recalling HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English-language labeling as required by federal regulations.

    Product
    HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0736-2021·2021-08-25

    Teva Octreotide Acetate Injection Recalled for Sterility Assurance Failure

    Teva Pharmaceuticals is recalling Octreotide Acetate Injection 1000 mcg/5mL vials nationwide due to lack of assurance of sterility. The recall affects 16,644 vials distributed nationally.

    Product
    Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0743-2021·2021-08-25

    Methylprednisolone Acetate Injectable Suspension recalled for sterility concerns

    Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension USP 80 mg/mL due to lack of assurance of sterility. The recall affects single-dose and multi-dose vials distributed nationwide, including Puerto Rico.

    Product
    Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0910-2021·2021-08-25

    HiPP HA Infant Formula Recalled for Inadequate Iron and Missing Labeling

    Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula (76,000 units) because some products contain less than the required iron per serving and lack mandatory FDA-compliant English labeling.

    Product
    HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0748-2021·2021-08-25

    Adenosine Injection Recalled for Lack of Sterility Assurance

    Teva Pharmaceuticals USA is recalling Adenosine Injection (60 mg/20 mL vials) nationwide due to lack of assurance of sterility, which could pose a serious health risk if the product is not sterile.

    Product
    Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0746-2021·2021-08-25

    Leucovorin Calcium for Injection Recalled Due to Sterility Assurance Concerns

    Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection in 100 mg/vial 10 mL single-use vials due to lack of assurance of sterility. The recall affects approximately 476,275 vials distributed nationwide, including Puerto Rico.

    Product
    Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0730-2021·2021-08-25

    DAUNOrubicin Hydrochloride Injection Recalled Due to Sterility Assurance

    Teva Pharmaceuticals USA is recalling DAUNOrubicin Hydrochloride Injection 20 mg/4mL due to lack of assurance of sterility. The recall affects 1,351 vials distributed nationwide, including Puerto Rico.

    Product
    DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0742-2021·2021-08-25

    Teva Alprostadil Injection Recalled for Lack of Sterility Assurance

    Teva Pharmaceuticals USA is recalling one lot of Alprostadil Injection USP due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.

    Product
    Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0744-2021·2021-08-25

    Teva Octreotide Acetate Injection Recall: Sterility Assurance Loss

    Teva Pharmaceuticals is recalling Octreotide Acetate Injection 100 mcg/mL (Lot #31327466B, expiring 08/2021) nationwide due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.

    Product
    Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0745-2021·2021-08-25

    Octreotide Acetate Injection 50 mcg/mL Recalled for Lack of Sterility Assurance

    Teva Pharmaceuticals is recalling Octreotide Acetate Injection 50 mcg/mL in single-dose vials due to lack of assurance of sterility. The recall affects specific lots distributed nationwide, including Puerto Rico.

    Product
    Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E081000·2021-08-25

    Deking LP Regulators Recalled Due to Fire Risk from Excessive Pressure

    Deking Corporation is recalling Winntec and WIC Model 6020 LP regulators installed in recreational vehicles. The parts may fail and cause excessive gas pressure, increasing the risk of fire.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V659000·2021-08-25

    Thomas Built Buses Recalls Saf-T-Liner HDX School Buses for Fire Risk

    Daimler Trucks North America is recalling 2016-2021 Thomas Built Buses Saf-T-Liner HDX school buses because a power steering hose may be routed with inadequate clearance, increasing the risk of a fire.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0909-2021·2021-08-25

    HiPP Dutch Stage 1 Infant Formula Recalled for Inadequate Iron Content

    Able Groupe Inc is recalling HiPP Dutch Stage 1 Combiotic Infant Milk Formula because it was not approved by the FDA and may contain insufficient iron for vulnerable infants, particularly those born prematurely or with low birth weight.

    Product
    HiPP Dutch Stage 1 Combiotic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0924-2021·2021-08-25

    HiPP UK Stage 1 Infant Milk Formula Lacks Required FDA Approval

    Able Groupe Inc is recalling HiPP UK Stage 1 Combiotic First Infant Milk Formula because required pre-market FDA notifications were not submitted. Some products contain insufficient iron and lack mandatory labeling.

    Product
    HiPP UK Stage 1 Combiotic First Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0747-2021·2021-08-25

    Leucovorin Calcium for Injection recalled for lack of sterility assurance

    Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product is sterile. Patients using recalled lot should consult their healthcare provider.

    Product
    Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0731-2021·2021-08-25

    Methylprednisolone Acetate Injectable Suspension Recall: Sterility Assurance

    Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL in single-dose and multi-dose vials nationwide due to lack of assurance of sterility.

    Product
    Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0740-2021·2021-08-25

    Adenosine Injection Vials Recalled for Sterility Assurance Failure

    Teva Pharmaceuticals is recalling Adenosine Injection, USP 60mg/20mL vials nationwide due to lack of assurance of sterility. The recall affects 4,249 vials distributed nationwide, including Puerto Rico.

    Product
    Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2315-2021·2021-08-25

    CT5000 X-ray System Contrast Dose Calculation Error Under Pounds Setting

    Philips CT5000 X-ray systems may incorrectly calculate contrast volume doses when patient weight units are set to pounds. The software error could recommend higher-than-intended contrast volumes.

    Product
    Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21189·2021-08-25

    Razor USA Recalls Hovertrax 2.0 Hoverboards with GLW Battery Packs for Fire Hazard

    Razor USA is recalling about 237,300 Hovertrax 2.0 self-balancing hoverboards with GLW lithium-ion battery packs that can overheat and catch fire or explode. More than 20 reports of overheating, smoke, or fire have been received, though no injuries have been reported.

    Product
    Hovertrax 2.0 Self-Balancing Scooters/Hoverboards with GLW Battery Packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2329-2021·2021-08-25

    Triathlon orthopaedic implant baseplate recalled for assembly defect

    Howmedica Osteonics is recalling the Triathlon Prim CEM baseplate (Lot JHS2H) due to a manufacturing defect that may prevent the insert from locking properly on the implant.

    Product
    Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2021·2021-08-25

    FDA Recalls DELTAVEN Safety I.V. Catheters Due to Sterilization Defect

    Delta Med SpA recalls 30,900 DELTAVEN Safety I.V. Catheters in Florida and Minnesota due to potential sterilization failures that could compromise device sterility.

    Product
    DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2021·2021-08-25

    Gore Propaten Vascular Graft Pediatric Shunt Diameter Labeling Error

    W L Gore is recalling certain Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling. Grafts labeled as 5 mm may actually be 6 mm and vice versa.

    Product
    Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2311-2021·2021-08-25

    Cell Marque Antibody Reagents Recalled for Incorrect Expiry Date Labeling

    Cell Marque antibody reagents used in pathology are recalled for labeling an incorrect expiry date (December 31, 2023 instead of December 31, 2022). Using expired reagent may result in weak or absent staining and false negative test results.

    Product
    Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2021·2021-08-25

    FDA Recalls WOLF-PAK IV Catheters Due to Sterilization Problems

    Delta Med SpA is recalling WOLF-PAK Self Safe Safety IV Catheters due to sterilization defects affecting approximately 40,000 units in Florida and Minnesota.

    Product
    WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2021·2021-08-25

    IV Catheters recalled due to potential sterilization failure

    229,320 DELTAVEN FASTFLASH IV catheters distributed in Florida and Minnesota are being recalled due to sterilization defects. The medical devices may not be sterile, posing contamination and infection risks to patients.

    Product
    DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2296-2021·2021-08-25

    FDA Recalls DELTAVEN Y Safety IV Catheters Due to Sterilization Issues

    Delta Med SpA is recalling DELTAVEN Y DNL Safety IV Catheters with closed system due to sterilization problems. The recalled units may lack proper sterility and pose a risk to patients.

    Product
    DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0915-2021·2021-08-25

    HiPP German Stage 2 Infant Formula Lacks Required FDA Pre-Market Approval and Labeling

    Able Groupe Inc is recalling HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula because it was not submitted for required FDA pre-market notification and lacks mandatory English labeling statements.

    Product
    HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0867-2021·2021-08-25

    Moonwalk 70% Dark Chocolate Bar Recalled for Undeclared Milk

    Cocanu LLC is recalling Moonwalk 70% dark chocolate bars because milk is not declared on the label, even though lactose is present. The product may pose a risk to consumers with milk allergies.

    Product
    Moonwalk 70% dark chocolate bar. It is packaged in white shiny paper with blue print. Net Weight: 1.2 oz / 35gr. No UPC. The label is read in parts: "***Moonwalk ***a 70% dark chocolate bar ***chocolate, cacao nibs and pop rocks ***Contents: cacao beans, cacao butter, cane sug
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2322-2021·2021-08-25

    RUSCH Endotracheal Tube Cuff Inflation Malfunction Without Pilot Balloon Indication

    Teleflex recalls RUSCH endotracheal tubes because the cuff can be inflated while the pilot balloon remains flat, preventing proper monitoring of cuff pressure.

    Product
    RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e) 112082070 f) 112082075 g) 112082080 h) 112082085 i) 112082090 j) 112082095 k) 112082100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2021·2021-08-25

    IV Catheters Recalled Due to Possible Missing Sterility

    Delta Med SpA is recalling NEO DELTA Self Safe 1 IV catheters due to possible missing sterility. The recall affects 5,000 units distributed in Florida and Minnesota.

    Product
    NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2021·2021-08-25

    OPTI SARS-CoV-2 RT-PCR Test Kits Recalled for False Positive Results

    OPTI Medical Systems is recalling COVID-19 test kits due to a precipitation issue that may cause false positive results in 5-10% of affected vials. No illnesses have been reported.

    Product
    OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2313-2021·2021-08-25

    NEO-KATH Caudal Catheter Set Recalled Due to Stylet Protrusion Risk

    Epimed International is recalling the NEO-KATH Caudal Set (REF 201-2430) because the stylet may protrude from the catheter's tip, potentially causing tissue injury. The recall affects 140 units distributed in the US and internationally.

    Product
    NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0908-2021·2021-08-25

    HiPP AR Germany Anti-Reflux Infant Formula Lacks Required FDA Approval and Labeling

    Able Groupe Inc is recalling HiPP AR Germany Anti-Reflux Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English labeling required by federal regulations.

    Product
    HiPP AR Germany Anti-Reflux Milk Formula
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2319-2021·2021-08-25

    RUSCH Slick Set Cuffed Endotracheal Tubes Recalled for Improper Cuff Inflation

    Teleflex Medical Europe Ltd. is recalling RUSCH Slick Set Cuffed Endotracheal Tubes because the cuff can inflate while the pilot balloon remains flat, potentially affecting airway pressure monitoring.

    Product
    RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2303-2021·2021-08-25

    IV Catheters Recalled by FDA for Sterilization Defects

    Delta Med is recalling NEO DELTA SELFSAFE PUR T IV catheters due to possible sterilization failures. The recall affects 14,000 units distributed in Florida and Minnesota.

    Product
    NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2314-2021·2021-08-25

    Brilliance iCT Computed Tomography Systems Recalled for Contrast Dosing Error

    Philips Brilliance iCT CT systems with SynchRight P3T software may recommend incorrect contrast volume when patient weight is entered in pounds, potentially affecting patient safety.

    Product
    728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2304-2021·2021-08-25

    I.V. Catheter Recall Due to Possible Sterilization Failure

    Delta Med recalls NEO DELTA SELFSAFE PUR T I.V. catheters distributed in Florida and Minnesota due to sterilization problems. Non-sterile catheters pose infection risks.

    Product
    NEO DELTA SELFSAFE PUR T, I.V. Catheter:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2299-2021·2021-08-25

    I.V. Catheter Recall: Sterilization Defects in NEO DELTA Self Safe Devices

    Delta Med is recalling 10,000 units of NEO DELTA Self Safe I.V. Catheters due to sterilization defects. Affected devices were distributed in Florida and Minnesota.

    Product
    NEO DELTA Self Safe, I.V. Catheter REF 3738222
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2316-2021·2021-08-25

    CT system software error recommends excessive contrast volume

    A software defect in Philips CT imaging systems causes incorrect contrast volume calculations when patient weight units are set to pounds, resulting in increased contrast dosing recommendations. Three units with specific serial numbers are affected.

    Product
    728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0919-2021·2021-08-25

    Holle Goat Stage 1 Organic Infant Milk Formula Recalled for Labeling Violations

    Able Groupe Inc is recalling Holle Goat Stage 1 Organic Infant Milk Formula because required FDA pre-market notifications were not submitted and products lack mandatory labeling statements in English.

    Product
    Holle Goat Stage 1 Organic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2317-2021·2021-08-25

    IQon Spectral CT System Software Error Increases Contrast Volume

    Philips IQon Spectral CT systems can recommend excessive contrast volume when patient weight is set to pounds due to a SynchRight software calculation error, potentially resulting in patient overdose.

    Product
    728332 IQon Spectral CT-Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2301-2021·2021-08-25

    NEO DELTA Self Safe T IV Catheters Recalled for Sterilization Failure

    NEO DELTA Self Safe T IV catheters may lack sterility due to sterilization problems. The FDA is recalling 20,000 units distributed in Florida and Minnesota.

    Product
    NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2318-2021·2021-08-25

    CT X-ray System Software Miscalculates Contrast Volume with Pounds Unit Setting

    Philips 728333 Spectral CT 7500 systems with SynchRight software may incorrectly calculate and recommend increased contrast volume when patient weight is set to pounds. Affected system should be updated to prevent excess contrast dosing.

    Product
    728333 Spectral CT 7500 -Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2326-2021·2021-08-25

    Surgical stapler mislabeled with incorrect device size

    Ethicon is recalling ECHELON FLEX Powered Plus Staplers because the product packaging is mislabeled; packages labeled as 60mm contain 45mm devices, which could affect surgical outcomes if the incorrect size is used.

    Product
    ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2021·2021-08-25

    DELTAVEN Y IV Catheters Recalled Over Potential Sterilization Defect

    Delta Med is recalling DELTAVEN Y IV Catheters in Florida and Minnesota due to potential sterilization defects. The devices may not be properly sterilized, posing infection risks to patients.

    Product
    DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2324-2021·2021-08-25

    CIRCUL8 LUXE DVT Prevention Device Marketed Without FDA Clearance

    The CIRCUL8 LUXE DVT Prevention Device is being recalled because it was marketed without FDA clearance. The device is intended to aid in the prevention of deep vein thrombosis.

    Product
    CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0927-2021·2021-08-25

    Kendamil Organic Stage 2 Infant Formula Recalled for Missing Labeling

    Able Groupe Inc is recalling Kendamil Organic Stage 2 Follow on Milk Formula because required pre-market FDA notifications were not submitted and labeling does not comply with federal requirements.

    Product
    Kendamil Organic Stage 2 Follow on Milk Formula
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2302-2021·2021-08-25

    I.V. Catheter Recall Due to Sterilization Failures

    Delta Med is recalling approximately 1,400 NEO DELTA SELFSAFE PUR 1 I.V. catheters (Lot 00A1160806) distributed in Florida and Minnesota due to sterilization process defects that may result in non-sterile devices.

    Product
    NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2306-2021·2021-08-25

    Philips EPIQ Ultrasound Systems Control Panel Arm Swivel Lock May Fail

    Philips EPIQ ultrasound system control panel arm swivel locks can fail, allowing the monitor to swivel freely during positioning or transport, potentially causing user or patient musculoskeletal injury.

    Product
    EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
    Category
    Medical Device
    Distribution
    Distributed nationwide

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