The Recall Desk

Archive

March 2024 recalls

556 recalls were announced in March 2024.

What the numbers show

Critical
24
Severe
151
High
334
Moderate
45
Low
2

Of the 556 recalls this month scored against our rubric, 4% are Critical, 27% are Severe.

301–400 of 556

  • ModerateFDA (Devices)·Z-1248-2024·2024-03-13

    MRI Systems Show Incorrect Spatial Field Gradient Values

    Canon Medical's MRI systems display incorrect Spatial Field Gradient values that are lower than actual, which may cause discomfort for patients with MR-conditional implanted devices during scanning.

    Product
    MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1037-2024·2024-03-13

    Frios Gourmet Pops Fruity Pebbles popsicles recalled for undeclared Yellow #5

    Frios Gourmet Pops Fruity Pebbles Popsicles are being recalled due to undeclared Yellow #5 color additive. Consumers with sensitivity or allergy to tartrazine should not consume the product.

    Product
    Frios Gourmet Pops - Fruity Pebbles Popsicle 3oz frozen popsicle packaged individually in clear plastic sleeve. 48 popsicles per box. *Sold directly to end consumer via food truck
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Drugs)·D-0364-2024·2024-03-13

    Clindamycin Phosphate Topical Solution recalled for defective container leakage

    Contract Pharmaceuticals Limited Canada is recalling 45,875 bottles of Clindamycin Phosphate Topical Solution USP 1% due to defective containers that leak slowly. The product was distributed nationwide in the U.S. and Puerto Rico.

    Product
    Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0367-2024·2024-03-13

    Mercaptopurine Tablets Recalled Due to Failed Dissolution Specifications

    Stason Pharmaceuticals recalls Mercaptopurine Tablets, USP 50 mg due to failed dissolution specifications at 9 months. Dissolution results were slightly below the required specification.

    Product
    Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1032-2024·2024-03-13

    Hazelnut type flavor product recalled for formula manufacturing deviation

    Synergy Flavors Inc is recalling NAT & ART HAZELNUT TYPE FLAVOR #521510 because the product was not manufactured in accordance with its formula specifications.

    Product
    NAT & ART HAZELNUT TYPE FLAVOR #521510, in 6 gallon and "275" tote
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·24V194000·2024-03-12

    E-One Recalls 2024 Commercial and Cyclone N Vehicles for Electrical Fire Risk

    E-One is recalling 22 model-year 2024 vehicles equipped with specific multiplex nodes due to a firmware defect that can cause electrical circuits to overheat and increase fire risk.

    Product
    E-ONE — E-ONE CYCLONE N, TYPHOON, TYPHOON N, COMMERCIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V192000·2024-03-12

    Cummins Recalls 2023-2024 Power Generation Generator Sets Due to Damper Risk

    Cummins is recalling 2023-2024 Power Generation C275D2RE trailers because improperly tightened vibration damper cap screws may cause the damper to separate, posing an injury risk.

    Product
    CUMMINS POWER GENERATION — CUMMINS POWER GENERATION GENERATOR SET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·012-2024·2024-03-10

    Jen's Breakfast Burritos Recalls Ready-to-Eat Products Due to Listeria Risk

    Jen's Breakfast Burritos, LLC is recalling approximately 144 pounds of ready-to-eat breakfast burritos due to possible Listeria monocytogenes contamination.

    Product
    Jen's Breakfast Burritos, LLC, Recalls Ready to Eat Breakfast Burrito Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·24V186000·2024-03-08

    Coachmen Prism Motorhomes Recalled for Incorrect Seat Belt Labeling

    Forest River is recalling 2023-2024 Coachmen Prism motorhomes because the Federal Information label may list the wrong number of seat belts, leading to incorrect cargo capacity information.

    Product
    COACHMEN — COACHMEN PRISM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V185000·2024-03-08

    2024 Ford Maverick Fuel Tank Defect Increases Fire Risk

    Ford is recalling certain 2024 Maverick vehicles because the fuel tanks may have an open pinch joint that allows fuel to leak. In the presence of an ignition source, a fuel leak increases the risk of vehicle fire.

    Product
    FORD — FORD MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V189000·2024-03-08

    2024 Ford Bronco Rear Door Latch May Open When Child Safety Lock Is On

    Ford is recalling certain 2023-2024 Bronco 4-door vehicles because the left-side rear door may open from inside even when the child safety lock is engaged, increasing the risk of injury.

    Product
    FORD — FORD BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V187000·2024-03-08

    Ford Bronco Sport and Escape fuel injector fire risk recall

    Ford is recalling the 2022-2023 Bronco Sport and 2022 Escape with 1.5L engines due to a fuel injector that may crack and leak fuel, creating a fire risk in the engine compartment.

    Product
    FORD — FORD ESCAPE, BRONCO SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V191000·2024-03-08

    Genesis vehicles turbocharger oil feed pipe deterioration recall

    Hyundai is recalling certain Genesis G70, G80, and G90 vehicles with 3.3-liter turbocharged engines because the left turbocharger oil feed pipe may deteriorate and leak oil, increasing the risk of engine compartment fire. Hyundai will replace the affected pipe free of charge.

    Product
    GENESIS — GENESIS G90, G80, G70
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E023000·2024-03-08

    Ford Recalls Super Duty Headlights for Excessive Brightness and Glare

    Ford is recalling certain Super Duty High Series Headlights sold as replacement parts for 2017-2019 vehicles because they may be too bright, increasing crash risk.

    Product
    EXTERIOR LIGHTING:HEADLIGHTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V188000·2024-03-08

    Ford Recalls 2020 Explorers for Rearview Camera Electrical Defect

    Ford is recalling 2020 Explorers because a poor electrical connection may cause the rearview camera to display a blank or distorted image, increasing crash risk.

    Product
    FORD — FORD EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E022000·2024-03-08

    Orscheln Recalls Parking Brake Levers Due to Latch Failure Risk

    Orscheln is recalling specific parking brake levers because the secondary latch may fail, allowing the brake to release unexpectedly and causing the vehicle to roll away.

    Product
    PARKING BRAKE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·24144·2024-03-07

    High-Powered Magnetic Ball Sets Recalled Due to Ingestion Hazard

    Magnetic Stones Toy Creativity Development DIY Magnetic Beads (5mm) sold on Walmart.com from August 2022 through April 2023 are recalled because the magnets exceed federal toy magnet limits and pose an ingestion hazard. Consumers should stop using them immediately and contact Joybuy for return instructions.

    Product
    Magnetic Stones Toy Creativity Development DIY Magnetic Beads, 5mm (.2 inch)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalCPSC·24147·2024-03-07

    Getallfun 216-Piece 5mm Magnetic Ball Sets Recalled for Ingestion Hazard

    Getallfun recalls 216-Piece 5mm Magnetic Ball Sets because they fail to meet federal toy safety standards. High-powered magnets can perforate or block the intestines if swallowed, risking serious injury or death.

    Product
    216-Piece 5mm Magnet Balls
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V181000·2024-03-07

    Spartan Fire Recalls 2023-2024 Fire Trucks Due to Electrical Fire Risk

    Spartan Fire is recalling 2023-2024 Gladiator, MetroStar, and other fire trucks because a firmware defect can cause electrical circuits to overheat and increase fire risk.

    Product
    SPARTAN FIRE — SPARTAN FIRE, KME METROSTAR, redundant PANTHER, GLADIATOR, FC-94
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·011-2024·2024-03-07

    Johnsonville Turkey Kielbasa Recalled for Rubber Contamination

    Salm Partners is recalling Johnsonville Polish Kielbasa Turkey Sausage due to possible rubber contamination. No injuries have been reported.

    Product
    Salm Partners, LLC — Salm Partners, LLC, Recalls Johnsonville Polish Kielbasa Turkey Sausage Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·24V182000·2024-03-07

    Kalmar Recalls 2023 Ottawa T2 Vehicles Due to Steering Gear Defect

    Kalmar is recalling 2023 Ottawa T2 vehicles because steering gear assemblies may have fewer recirculating balls than required, potentially causing a loss of steering control.

    Product
    KALMAR — KALMAR OTTAWA T2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V184000·2024-03-07

    2023 Honda Ridgeline and Passport steering gearbox may detach

    Honda is recalling certain 2023 Ridgeline and Passport vehicles because the steering gearbox inner ball joint housing may loosen and detach, potentially causing loss of steering control.

    Product
    HONDA — HONDA RIDGELINE, PASSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V180000·2024-03-07

    2025 International LT vehicles recalled for reversed turn signal wiring

    Navistar is recalling certain 2025 International LT vehicles because two wires in the taillight jumper harness may be reversed, causing turn signals to activate in the wrong direction. This safety defect may confuse other road users and increase crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL LT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24153·2024-03-07

    SINGES 3-in-1 High Chair and Booster Seats Recalled for Fall Hazard

    SINGES 3-in-1 High Chairs and Booster Seats sold on Walmart.com violate federal safety regulations. The product can tip over or collapse, presenting a fall hazard to children. No injuries have been reported.

    Product
    SINGES 3-in-1 Baby High Chairs and Booster Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24155·2024-03-07

    Bubble Bear Crib Mattresses Recalled Due to Fire Hazard

    Bubble Bear crib mattresses violate federal flammability and labeling requirements, posing a fire hazard to children. About 750 units sold on Amazon.com from May to July 2022 are affected.

    Product
    Bubble Bear Crib Mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24150·2024-03-07

    Eco Terra Hybrid Latex Mattresses recalled for fire hazard

    Sleep Technologies is recalling about 84 Eco Terra Hybrid Latex Mattresses sold online in August 2022 because they violate federal flammability requirements and pose a fire hazard. No injuries have been reported.

    Product
    Eco Terra Hybrid Latex Mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24149·2024-03-07

    Yamaha PA-10 AC Power Adaptors Recalled for Electrical Hazards

    Yamaha is recalling about 34,500 PA-10 AC Power Adaptors because the upper and lower cases can crack and separate, exposing electrical wiring and creating electrical shock and electrocution hazards.

    Product
    Yamaha PA-10 AC Power Adaptors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24151·2024-03-07

    Bracelet in Skechers Gift Sets Recalled for High Lead and Cadmium

    Fossil Group is recalling the braided black bracelet in Skechers watch and jewelry gift sets sold from August 2023 through January 2024 because the metal clasp contains high levels of lead and cadmium, which are toxic to children.

    Product
    Bracelet sold with Skechers Watch and Jewelry Gift Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24146·2024-03-07

    Anker EverFrost Battery Powered Coolers Recalled for Battery Fire Hazard

    Anker is recalling about 5,480 EverFrost battery-powered coolers because the lithium-ion batteries can overheat and catch fire. The company has received five reports of overheating, smoke, and fire, with no injuries reported.

    Product
    EverFrost Battery Powered Coolers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24145·2024-03-07

    Jool Baby Nova Infant Swings Recalled for Suffocation Hazard

    Jool Baby is recalling about 650 Nova infant swings because they have an incline angle greater than 10 degrees and were designed for infant sleep, violating federal safety regulations. The swings also lack required warning labels about sleep safety.

    Product
    Jool Baby Nova Baby Infant Swings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24152·2024-03-07

    Tommy Bahama Children's Pants Sets Recalled for Choking Hazard

    TJX is recalling approximately 14,500 Tommy Bahama brand children's brown stretch twill pants sets sold at Marshalls nationwide. Plastic pieces on the faux drawstrings can detach, posing a choking hazard to children.

    Product
    Tommy Bahama brand children's pants sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24148·2024-03-07

    GT LaBomba Bicycles Recalled Due to Fall and Injury Hazards

    GT Bicycles LLC is recalling about 3,040 GT LaBomba bicycles from model years 2019–2023 because the headtube/downtube weld can become damaged and separate from the frame, creating a fall hazard. Consumers should stop using the bicycles and contact an authorized GT dealer for a free replacement frame.

    Product
    GT LaBomba bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24154·2024-03-07

    Textron Arctic Cat Catalyst 600 Snowmobiles Recalled for Brake Loss Risk

    Textron Specialized Vehicles is recalling about 2,700 model year 2024 Arctic Cat Catalyst 600 snowmobiles because the brake line can contact the brake disc, causing brake damage and potential brake loss. No injuries have been reported, but three reports of brake line damage have been received.

    Product
    Model Year 2024 Arctic Cat Catalyst 600 Series Snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1136-2024·2024-03-06

    Centurion LVAD Maintenance Kits Recalled for Potential Sterility Failure

    Medline Industries is recalling Centurion LVAD maintenance kits and driveline management trays due to sterility concerns in irrigation solution components from Nurse Assist. The solutions may be non-sterile and could pose infection risks.

    Product
    Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640; c) DAILY DRIVELINE MGMT SYSTEM, REF DM600; d) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; e) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1123-2024·2024-03-06

    Medline Surgical Kits Recalled for Potential Sterility Failure

    Medline Industries is recalling 533 units of gynecological laparoscopy kits and trays manufactured with Nurse Assist irrigation and saline components due to potential lack of sterility. The affected products were distributed nationwide in the U.S. and internationally.

    Product
    Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e) GYN LAPAROSCOPY CDS, REF CDS983913V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1120-2024·2024-03-06

    Medline wound care trays recalled due to sterility defect

    Medline Industries is recalling Wound Care Trays due to potential lack of sterility in solution components. The recall affects 72,624 units distributed nationwide and internationally.

    Product
    Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1010-2024·2024-03-06

    Sargento Parmesan Cheese Products Recalled for Listeria Monocytogenes Contamination

    Sargento is recalling 1,791 cases of Parmesan cheese products distributed to 15 states due to potential Listeria monocytogenes contamination.

    Product
    Parmesan cheese packaged in the following configurations: 1. Sargento Fresh Grated Parmesan Cheese Pack Size 500/0.5 oz. Material #10000278, UPC 46100348659. 2. Sargento Part #10132 Fancy Shredded Parmesan Cheese Pack Size 500/0.5 oz. Material #10000284, UPC 4610033499
    Category
    Food
    Distribution
    15 states
  • CriticalFDA (Devices)·Z-1070-2024·2024-03-06

    VOCSN Pediatric breathing package spiral wrap detachment risk during ventilation

    Ventec Life Systems recalls VOCSN Patient Breathing Packages because the spiral wrap may detach during ventilation, compromising the breathing circuit and creating a risk of serious injury or death, especially for ventilator-dependent patients.

    Product
    VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ven
    Category
    Medical Device
    Distribution
    8 states
  • CriticalFDA (Food)·F-1007-2024·2024-03-06

    Ready Pac Bistro Queso Crunch Salad Kit recalled for Listeria contamination risk

    Ready Pac Bistro Queso Crunch Salad Kit (UPC 077745256139) is recalled due to potential Listeria monocytogenes contamination. Affected products have use-by dates between January 13 and February 18, 2024.

    Product
    Ready Pac Bistro Queso Crunch Salad Kit 24 oz. UPC 077745256139
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Devices)·Z-1091-2024·2024-03-06

    Medline Tracheostomy Care Kits Recalled for Non-Sterile Component Solutions

    Medline Industries is recalling care and cleaning kits for tracheostomy and stomas due to component solutions that may not be sterile. The affected kits contain Nurse Assist-manufactured saline and irrigation solutions distributed in the U.S., Puerto Rico, Canada, UAE, and Panama.

    Product
    MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA1482
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1011-2024·2024-03-06

    Sargento Fancy Shredded Swiss Cheese Recalled for Listeria Contamination

    Sargento Foods is recalling 1,143 cases of Fancy Shredded Swiss Cheese due to potential Listeria monocytogenes contamination. The affected products were distributed across 15 US states.

    Product
    Swiss cheese packaged in the following configurations: 1. Sargento Fancy Shredded Swiss Cheese, Pack Size 400/1 oz. Net Wt 25.000 lbs. Material #10000390, UPC 46100349816. 2. Sargento Fancy Shredded Swiss Cheese, Pack Size 500/0.5 oz. Net Wt 15.625 Material #100010
    Category
    Food
    Distribution
    15 states
  • CriticalFDA (Devices)·Z-1113-2024·2024-03-06

    Medline Medical Kits Recalled Due to Potential Lack of Sterility

    Medline is recalling approximately 3,900 medical device kits and trays nationwide due to potential sterility failures in irrigating solution components. The affected products may not be sterile, creating a risk of infection.

    Product
    Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYNDA2863H; c) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518; d) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518H; e) KIT ULTRASOUND PIV START, REF DYNDV2445;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1102-2024·2024-03-06

    Surgical kits and trays recalled due to lack of sterility

    Medline Industries is recalling over 3,200 surgical kits and trays containing components that may lack sterility. The recalled products could pose infection risk to patients if used during surgical procedures.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; e) GASTRIC CULTURE PACK, REF DYNJ53966A; f) GASTRI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1000-2024·2024-03-06

    ELV Alipotec tejocote supplement recalled due to toxic yellow oleander contamination

    World Green Nutrition's ELV Alipotec tejocote supplement contains toxic yellow oleander instead of the labeled ingredient. FDA Class I recall affects approximately 113,500 units.

    Product
    ELV ALIPOTEC brand MEXICAN TEJOCOTE ROOT SUPPLEMENT PIECES (RAIZ DE TEJOCOTE MEXICANO SUPLEMENTO EN TROZOS), NET. WT, 0.3 0Z (7g)
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-1012-2024·2024-03-06

    Sargento Shredded Asiago Cheese Recalled for Listeria Contamination

    Sargento Foods is recalling Asiago cheese products contaminated with Listeria monocytogenes. The recall affects 264 cases distributed across 15 states; consumers should not consume affected products.

    Product
    Asiago cheese packaged in the following configurations: 1. Sargento Part #10197, Fancy Shredded Fresh Asiago Cheese Pack Size 500/0.75 oz. Material #10001006, UPC 46100342688. 2. Sargento Shredded Fresh Asiago Cheese. Pack Size 400/1 oz. Net Wt 25.000 lbs. Mat
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Devices)·Z-1065-2024·2024-03-06

    AirLife Manual Resuscitator recalled for broken components causing ventilation failure

    Vyaire Medical is recalling approximately 1.8 million AirLife Adult Manual Resuscitators worldwide due to faulty molded components that may fail to deliver proper ventilation, risking hypoventilation and hypoxia.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1134-2024·2024-03-06

    Medical device kits recalled due to potential sterility failure

    Medline Industries is recalling IV securement kits and neonatal PICC line insertion trays due to potential lack of sterility in Nurse Assist components. Approximately 11,812 units are affected.

    Product
    Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSERTION TRAY, REF CVI2025; c) NEONATAL PICC LINE INSERTION TRAY, REF CVI4570; d) SECONDARY IV START KIT, REF IV8695A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1122-2024·2024-03-06

    Medline kits and trays recalled for potential lack of sterility

    Medline Industries is recalling surgical kits and trays containing irrigation solutions that may not be sterile due to manufacturing issues. The non-sterile solutions could increase infection risk during surgical and obstetrical procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DELIVERY, REF DYNJ83093;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1062-2024·2024-03-06

    AirLife manual resuscitator component defect risks ventilation failure

    Vyaire Medical is recalling AirLife Adult Manual Resuscitators with defective duckbill and ring components that may fail to provide ventilation, risking hypoventilation or hypoxia. The defect affects units manufactured in 2017 and earlier.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1003-2024·2024-03-06

    Rojo Black Bean 6 Layer Dip Recalled for Potential Listeria Contamination

    Lakeview Farms LLC is recalling Rojo Black Bean 6 Layer Dip due to potential Listeria monocytogenes contamination. Consumers should not consume the product and should discard or return it.

    Product
    Rojo Black Bean 6 Layer Dip packaged in 20oz PET plastic containers, sold in sleeve with two containers per sleeve. 12 sleeves per case.
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1114-2024·2024-03-06

    Medline Port Removal Kits Recalled for Potential Sterility Loss

    Medline Industries recalls certain port removal kits due to potential loss of sterility in irrigation solutions manufactured using specific component lots.

    Product
    Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF DYNDA2936H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1064-2024·2024-03-06

    AirLife Manual Resuscitator Recall Due to Broken Components Preventing Ventilation

    Vyaire Medical is recalling 1,020,330 AirLife Adult Manual Resuscitators due to defective components that can fail to deliver proper ventilation. When components break or disassemble, users may experience hypoventilation or hypoxia, potentially fatal complications.

    Product
    AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1104-2024·2024-03-06

    Medline Catheterization Kits Recalled for Potential Sterility Defect

    Medline Industries is recalling catheterization kits for potential sterility defects in component irrigation solutions. Non-sterile solutions used in medical procedures could result in serious infections.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1125-2024·2024-03-06

    Medline Irrigation Kits and Packs Recalled for Sterility Defect

    Medline Industries recalls 279 irrigation and saline kits, trays, and packs due to potential lack of sterility in components used to manufacture them. Solutions may be non-sterile.

    Product
    Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C PACK, REF DYNJ67214F; c) D&C PACK, REF DYNJ67214G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1117-2024·2024-03-06

    Medline Surgical Kits Recalled for Potential Lack of Sterility

    Medline Industries recalls multiple surgical and central line kits containing Nurse Assist components that may lack sterility. Approximately 86,699 units of these medical device kits have been distributed nationwide.

    Product
    Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c) DRESSING CHANGE TRAY, REF DYNDC3131A; d) DRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e) DRSG CHANGE TRAY W/ CHG, REF DT21460B; f)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1061-2024·2024-03-06

    AirLife Adult Manual Resuscitator Recalled for Ventilation Failure Risk

    Vyaire Medical recalls 3.6 million AirLife Adult Manual Resuscitators due to defective oxygen tubing components that may fail to deliver proper ventilation, risking hypoxia. Affected units were manufactured in 2017 or earlier.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1101-2024·2024-03-06

    Medline Surgical Kits Recalled for Potential Sterility Defects

    Medline is recalling surgical kits and trays with components that may lack sterility. The affected products were distributed nationwide and internationally.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT, REF DYKE1718B; d) DOUBLE CENTRAL LINE CAP CHANGE, REF DYNDC2214G; e) ENT PACK, REF DYNJ55334C; f) ENT PACK, REF DYNJ4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1097-2024·2024-03-06

    Medline Medical Kits and Trays Recalled for Non-Sterile Solutions

    Medline Industries is recalling multiple medical kits and trays containing irrigation solutions that may be non-sterile. The affected products are used in surgical and invasive procedures; non-sterile solutions could cause serious infections.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION PACK,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1116-2024·2024-03-06

    Medline Prep Kits Recalled Due to Non-Sterile Components

    Medline is recalling 1,270 prep kits containing components that may lack sterility. Solutions from Nurse Assist used in the kits may not be sterile.

    Product
    Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1106-2024·2024-03-06

    MEDLINE Surgical Kits Recalled Due to Potential Sterility Failure

    MEDLINE is recalling surgical kits, trays, and packs due to potential lack of sterility in component solutions. The recalled products were distributed nationwide and internationally.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1129-2024·2024-03-06

    Medical maintenance flush kits recalled for potential sterility defect

    Medline Industries is recalling Centurion maintenance flush and blood draw kits due to potential sterility issues in component solutions. Affected lot numbers are 2022031480 and 2022041180.

    Product
    Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1060-2024·2024-03-06

    AirLife Adult Manual Resuscitator Kits Recalled for Component Failure

    Vyaire Medical is recalling 3,636 AirLife Adult Manual Resuscitator kits. Manufacturing defects can cause component failure that prevents proper ventilation, potentially resulting in fatal hypoxia.

    Product
    AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1115-2024·2024-03-06

    Blood Draw and Lab Collection Kits Recalled for Potential Sterility Defect

    Medline Industries is recalling blood draw and lab collection kits due to potential lack of sterility in component solutions. The affected kits could contain non-sterile solutions, posing risks in clinical procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW KIT, REF DYNDH1641AH; d) OB LAB COLLECTION KIT, REF DYNDH1719A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1126-2024·2024-03-06

    Medline Surgical Kits Recalled for Potential Sterility Failure

    Medline Industries recalls surgical kits and trays manufactured with non-sterile solutions due to contaminated Nurse Assist components. Kits distributed nationwide and internationally may lack proper sterility, posing infection risk.

    Product
    Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARACT PACK, REF DYNJ54869F; d) CATARACT PREP PACK, REF DYNJ44917L; e) E-BLEPH CDS, REF CDS983585G; f) EYE CDS, REF CDS983916G; g) EYE KIT,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1103-2024·2024-03-06

    Medline surgical kits and trays recalled for sterility defects

    Medline Industries recalls 5,969 surgical kits and trays that may lack sterility due to components from Nurse Assist. The non-sterile irrigation solutions could compromise product safety.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1108-2024·2024-03-06

    Medline Instrument Trays Recalled for Potential Sterility Defect

    Medline Industries is recalling 228 medical device trays due to potential sterility defects in component solutions used in medical procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1105-2024·2024-03-06

    Medline Dialysis Kits Recalled for Potential Sterility Defects

    Medline Industries is recalling certain dialysis kits and trays due to potential sterility defects in component irrigation solutions and saline products. Non-sterile solutions used in dialysis could cause infection.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1112-2024·2024-03-06

    Medline Medical Kits and Trays Recalled for Potential Sterility Failure

    Medline Industries is recalling certain sterile medical kits and trays that contain component solutions with a potential lack of sterility. Non-sterile solutions could result in infection or contamination during medical procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1110-2024·2024-03-06

    Medline wound irrigation kits recalled for potential sterility defects

    Medline Industries is recalling approximately 2,205 wound irrigation kits due to potential lack of sterility in component solutions. Non-sterile irrigation solutions pose a risk of infection during wound care.

    Product
    Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1090-2024·2024-03-06

    Medline Tracheal Care Trays Recalled Due to Sterility Concerns

    Medline Industries is recalling 385,028 tracheostomy care trays due to potential sterility issues with certain components. The kits were distributed nationwide and internationally.

    Product
    MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1096-2024·2024-03-06

    Medline Medical Kits Recalled for Potential Sterility Defect

    Medline Industries is recalling multiple surgical and critical care kits due to a potential lack of sterility in component solutions (sodium chloride irrigation, sterile water for irrigation, and saline flush syringes). Non-sterile solutions could expose patients to infection.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G, e) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I, f) FREQUENT DAILY VAD, REF DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1058-2024·2024-03-06

    AirLife Adult Manual Resuscitator tubing may fail to deliver proper ventilation

    Vyaire Medical is recalling 66,078 units of AirLife Adult Manual Resuscitator oxygen tubing worldwide due to component manufacturing defects that can cause device failure and inadequate ventilation.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1111-2024·2024-03-06

    Medline Medical Device Kits Recalled for Potential Sterility Loss

    Medline Industries is recalling 26,171 kits and trays containing potentially non-sterile irrigation solutions and syringes supplied by Nurse Assist, which could pose risks if used in medical procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE18
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1093-2024·2024-03-06

    Medline Bronchoscopy Tray Components Recalled for Potential Lack of Sterility

    Medline Industries is recalling certain Nurse Assist components used in Bronchoscopy Trays due to potential lack of sterility. Affected irrigation solutions and saline flush syringes may be non-sterile.

    Product
    MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1095-2024·2024-03-06

    Medline Medical Kits and Trays Recalled for Potential Sterility Failure

    Medline Industries is recalling certain medical kits and trays that may contain non-sterile solutions. Healthcare facilities should discontinue use of affected batches to prevent patient exposure to potential contamination.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b) PEDIATRIC PORT A CATH TRAY, REF DYNDC2128B; c) PK, RADIOLOGY, REF DYNJ44087A; d) PORT ACCESS PACK-LF, REF DYNJ0352159C; DYNJ0352159D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1124-2024·2024-03-06

    Medline Surgical Kits Recalled Due to Sterility Defect in Irrigation Solutions

    Medline Industries recalls certain surgical kits and trays because irrigation solution components may lack sterility, creating potential infection risk.

    Product
    Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1132-2024·2024-03-06

    Medline Centurion surgical trays and kits recalled for potential non-sterile solutions

    Medline Industries is recalling 14,234 units of Centurion surgical kits and trays that may contain non-sterile irrigation solutions. The affected products were manufactured using compromised Nurse Assist components.

    Product
    Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640A; c) CIRCUMCISION TRAY, REF CIT6180; d) INCISION & DRAINAGE TRAY, REF ID1690; e) LACERATION TRAY, REF SUT19510; f) LACERATION TRAY,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1016-2024·2024-03-06

    Sargento Shredded Cheese Recalled for Listeria Contamination

    Sargento Fancy Shredded Bistro Blends Nacho & Taco Cheese Blend is being recalled due to potential Listeria monocytogenes contamination. The affected product was distributed to retailers in 15 states.

    Product
    Sargento Part #10129 Fancy Shredded Bistro Blends Nacho & Taco Cheese Blend. Pack Size 500/.75 oz. Material #10000281, UPC 46100334157 Keep Refrigerated. Product of USA. Distributed By Sargento Foods Inc, Plymouth, WI 53073 USA.
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Devices)·Z-1131-2024·2024-03-06

    Medline Centurion Eye Prep Kit Sterilization Defect Recall

    Medline Industries is recalling Centurion Eye Prep Kits due to potential lack of sterility in irrigation solution components manufactured by Nurse Assist.

    Product
    Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1137-2024·2024-03-06

    Centurion breast biopsy kits recalled due to potential sterility issues

    Medline Industries is recalling Centurion breast biopsy kits due to a potential lack of sterility in component solutions.

    Product
    Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1100-2024·2024-03-06

    MEDLINE Serum Tear Kit Irrigation Solutions Recalled for Sterility Concerns

    Medline is recalling serum tear kit irrigation solutions due to potential sterility defects. The solutions may not be sterile, posing contamination risks during medical use.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1004-2024·2024-03-06

    Marketside Southwest Chopped Kit Recalled for Potential Listeria Contamination

    Ready Pac Foods is recalling Marketside Southwest Chopped Kit (10.3 oz.) due to potential Listeria monocytogenes contamination. Consumers should not consume the affected product.

    Product
    Marketside Southwest Chopped Kit 10.3 oz. UPC 681131305129
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Devices)·Z-1119-2024·2024-03-06

    Medline Tracheostomy Care Kits and Trays Recalled Due to Sterility Concerns

    Medline Industries is recalling tracheostomy care kits and trays due to potential lack of sterility in their component irrigation solutions. The non-sterile solutions pose a risk during patient care procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA3004; c) TRACHEOSTOMY CARE TRAY, REF DYND40650; d) TRAY,TRACH,W/PCLNR,14FR CATH N, REF DYND40594
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1127-2024·2024-03-06

    Medline Surgical Kits and Trays Recalled Due to Potential Sterility Defect

    Medline Industries is recalling surgical kits and trays that may contain non-sterile irrigation solutions. Affected products were manufactured with certain component lots that have a potential sterility defect.

    Product
    Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1629; c) CVL INSERTION KIT-LF, REF DYNJ48587A; d) EXTREMITY CDS, REF CDS983313I; e) EXTREMITY CDS, REF DYNJ902004D; f) EXTREMITY CDS, REF DYNJ902004F;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1059-2024·2024-03-06

    AirLife Adult Manual Resuscitator recalled for faulty component causing ventilation failure

    Vyaire Medical is recalling 8,220 AirLife Adult Manual Resuscitators with defective duckbill and ring components. The manufacturing defect may prevent proper ventilation and could lead to hypoxia or death.

    Product
    AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1107-2024·2024-03-06

    Dialysis Irrigation Solutions Recalled for Potential Sterility Defect

    Medline Industries is recalling 10,391 units of dialysis kits and accessory packs due to potential sterility defects in component solutions. Non-sterile irrigation fluids could cause serious infection if used.

    Product
    Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1163-2024·2024-03-06

    Medtronic Duet External Drainage System Recalled for Catheter Disconnection Risk

    Medtronic is recalling its Duet External Drainage and Monitoring System due to potential catheter disconnection from patient line stopcock connectors. This device is used to drain cerebrospinal fluid and reduce intracranial pressure.

    Product
    Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1009-2024·2024-03-06

    Sargento Cotija Cheese Products Recalled for Potential Listeria Contamination

    Sargento Foods is recalling specific Cotija cheese lots due to possible Listeria monocytogenes contamination. The recalled products were distributed across 15 U.S. states and consumers should discard or return them to retail.

    Product
    Cotija cheese packaged in the following configurations: 1. Sargento Course Grated Cotija Cheese Pack Size 6/5 lb. Material #10002578, UPC 46100352601. 2. Sargento Coarse Grated Cotija Cheese. Pack Size 500/0.5 oz. Net Wt. 15.625 lbs. Material #10003245, UPC 4610035517
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Devices)·Z-1118-2024·2024-03-06

    Medline Laceration Trays Recalled Due to Sterility Defect

    Medline is recalling laceration trays and medical kits with approximately 12,000 units due to sterility defects in component solutions. Non-sterile medical devices could pose infection risk during wound care procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION TRAY, REF SUT21580; c) LACERATION TRAY, REF DYNDL1484B;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1099-2024·2024-03-06

    Medline Centurion maintenance flush kits recalled for sterility failure

    Medline Industries is recalling Centurion maintenance flush and blood draw kits that may lack sterility due to defective components, potentially allowing infections during medical procedures.

    Product
    Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V178000·2024-03-06

    Prevost Recalls H3-45 Buses Due to Steering Column Joint Failure Risk

    Prevost is recalling 2022-2023 H3-45 and H3-45 VIP buses because steering column joints may fail, causing loss of steering control and increasing crash risk.

    Product
    PREVOST — PREVOST H3-45 VIP, H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1164-2024·2024-03-06

    Medtronic Duet External Drainage System catheter disconnection risk recalled

    Medtronic recalls Duet External Drainage and Monitoring System catheter units (REF 46915) due to potential disconnection from stopcock connectors. Worldwide distribution includes 14,139 units.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1166-2024·2024-03-06

    Medtronic Duet Catheter System Recalled for Potential Disconnection Risk

    Medtronic Duet External Drainage System catheters may disconnect from stopcocks, potentially compromising cerebrospinal fluid management. The FDA Class I recall affects 3,889 units distributed worldwide.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1109-2024·2024-03-06

    Medline Surgical Kits Recalled for Potential Lack of Sterility

    Medline Industries is recalling 139 surgical kits containing irrigation solutions with potential sterility issues. The recalled products were distributed nationwide and internationally.

    Product
    Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1063-2024·2024-03-06

    AirLife Adult Manual Resuscitator recalled for ventilation failure risk

    Vyaire Medical is recalling 4,572 units of AirLife Adult Manual Resuscitators due to defective components that may cause improper ventilation or complete ventilation failure, potentially resulting in hypoventilation, hypoxia, or death.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1165-2024·2024-03-06

    Medtronic Duet Ventricular Catheter Recalled for Disconnection Risk

    Medtronic is recalling 11,840 units of its Duet External Drainage and Monitoring System due to potential disconnection between the catheter and stopcock connectors. This defect could impair the device's ability to drain cerebrospinal fluid.

    Product
    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1015-2024·2024-03-06

    Sargento Cheddar Cheese Recalled for Listeria Contamination

    Sargento Foods is recalling 349 cases of cheddar cheese products due to potential Listeria monocytogenes contamination. Affected products were distributed to 15 states; consumers should not eat them.

    Product
    Cheddar cheese packaged in the following configurations: 1. Sargento Deep V Shredded Mild Cheddar Cheese. Pack Size 450/1 oz. Net Wt 28.125 lbs. Material #10000537, UPC 46100348611. 2. Sargento Part #29313, Thick "N Hearty Shredded Sharp Cheddar Cheese Pack Size 500/
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-1014-2024·2024-03-06

    Sargento White Cheddar Cheese Recalled for Listeria Monocytogenes

    Sargento Foods is recalling White Cheddar cheese products due to Listeria monocytogenes. The affected products were distributed in 15 states; consumers should discard them.

    Product
    White Cheddar cheese packaged in the following configurations: 1. Sargento Part #23340 Fancy Shredded Sharp White Cheddar Cheese. Pack Size 500/0.5 oz. Material #10001126, UPC 46100329313. 2. Sargento Fancy Shredded Mild White Cheddar Cheese. Pack Size 500/0.5 oz. Ne
    Category
    Food
    Distribution
    15 states

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