The Recall Desk

Archive

April 2024 recalls

478 recalls were announced in April 2024.

What the numbers show

Critical
6
Severe
89
High
326
Moderate
55
Low
2

Of the 478 recalls this month scored against our rubric, 1% are Critical, 19% are Severe.

1–100 of 478

  • SevereNHTSA·24V307000·2024-04-30

    Braun Ambulances Recalls 2023-2024 Models Due to Electrical Fire Risk

    Braun Ambulances is recalling 29 vehicles from 2023-2024 because a firmware defect can cause electrical circuits to overheat, increasing the risk of fire.

    Product
    BRAUN AMBULANCES — BRAUN AMBULANCES EXPRESS PLUS TYPE I, CHIEF XL TYPE I, EXPRESS TYPE III, CHIEF XL TYPE III
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V306000·2024-04-30

    Alfa Romeo Giulia Fuel Line Sensor Housing Recall

    Stellantis is recalling 2021 Alfa Romeo Giulia vehicles because a fuel line sensor housing may crack and leak fuel, increasing the risk of engine stall or fire.

    Product
    ALFA ROMEO — ALFA ROMEO GIULIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V302000·2024-04-29

    MINI Cooper SE battery housing can admit water causing fire or stall

    BMW is recalling certain 2020-2024 MINI Hardtop 2 Door (Cooper SE) vehicles because the high voltage battery housing may not have been sealed properly, allowing water to enter the battery.

    Product
    MINI — MINI COOPER SE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V304000·2024-04-29

    Nissan Sentra driveshaft may unseat causing fluid leak and power loss

    Nissan is recalling certain 2024 Sentra vehicles because the front left driveshaft may not be fully seated in the CVT assembly, or may have a loose or missing retaining clip.

    Product
    NISSAN — NISSAN SENTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V300000·2024-04-29

    Starcraft Recalls 2023 GSL Fifth Wheel Trailers Due to Fire Risk

    Starcraft RV is recalling 2023 GSL fifth wheel trailers because the cooktop LED backlight circuit board may overheat, increasing the risk of a fire.

    Product
    STARCRAFT RV FW — STARCRAFT RV FW STARCRAFT GSL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V301000·2024-04-29

    Motorhome cooktop control boards can overheat and cause fire

    Newmar is recalling certain 2022 Bay Star motorhomes because the LED backlight circuit board in the cooktop range may fail and overheat.

    Product
    NEWMAR — NEWMAR BAY STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V299000·2024-04-29

    Highland Ridge RV Recalls Trailers Due to Overheating Circuit Board Fire Risk

    Highland Ridge RV is recalling 681 model year 2022-2023 trailers because an LED backlight circuit board may overheat, increasing the risk of a fire.

    Product
    HIGHLAND RIDGE TT — HIGHLAND RIDGE TT, HIGHLAND RIDGE FW OPEN RANGE, SILVERSTAR, MESA RIDGE XLT, MESA RIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V303000·2024-04-29

    Alliance RV Recalls 2024 Avenue Travel Trailers Due to Wiring Defect

    Alliance RV is recalling 2024 Avenue travel trailers because an improperly wired inverter circuit could cause a breaker to overheat and increase fire risk.

    Product
    ALLIANCE RV — ALLIANCE RV AVENUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V305000·2024-04-29

    Reading Truck Equipment Recalls RM-78 Cranes Due to Taillight Height

    Reading Truck Body LLC is recalling 2022-2024 RM-78 crane bodies because taillights may be mounted too high, reducing visibility and increasing crash risk.

    Product
    READING TRUCK EQUIPMENT — READING TRUCK EQUIPMENT RM-78 CRANE BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·015-2024·2024-04-26

    802 VT Frozen Recalls Meat Pizza for Undeclared Soy Allergen

    802 VT Frozen is recalling approximately 8,221 pounds of frozen meat pizza because the product contains soy, a known allergen, that is not declared on the label.

    Product
    VT Pie and Pasta Co. — 802 VT Frozen Recalls Frozen Meat Pizza Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    7 states
  • SevereNHTSA·24V298000·2024-04-26

    Mercedes-Benz Recalls ML, GL, and R-Class Vehicles for Brake Booster Defect

    Mercedes-Benz is recalling 2006-2012 ML, GL, and R-Class vehicles because moisture in the brake booster can cause corrosion and brake failure.

    Product
    MERCEDES BENZ — MERCEDES BENZ, MERCEDES-BENZ GL550, ML350, ML450, AMG ML63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V297000·2024-04-26

    Micro Bird Recalls G5 School Buses for Brake and Steering Fluid Leak

    Micro Bird is recalling 2019-2022 G5 school buses because a faulty connection may cause a loss of power steering and brake assist, increasing crash risk.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V296000·2024-04-26

    Bucher Recalls Johnston and Bucher Trucks Due to Rear Door Pin Defect

    Bucher Municipal North America is recalling 2014-2020 Johnston and Bucher trucks because a corroded pin can cause the hydraulic rear door to fall, posing an injury risk.

    Product
    JOHNSTON — JOHNSTON, BUCHER VT651, VT801, VT652, VS651
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V295000·2024-04-26

    Winnebago motorhome cooktop circuit boards may fail and overheat

    Winnebago Industries is recalling certain 2021-2025 motorhomes because the LED backlight circuit board in the cooktop range may fail and overheat. 1,166 units affected.

    Product
    WINNEBAGO — WINNEBAGO FORZA, VISTA, INSPIRE, VITA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V293000·2024-04-26

    Ford Maverick body control module may deactivate rear tail lights

    Ford is recalling certain 2022-2024 Maverick vehicles because the Body Control Module may inadvertently deactivate one or both rear tail lights. 242,669 units are affected.

    Product
    FORD — FORD MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24210·2024-04-25

    JAKKS Pacific Recalls Mario Kart 24V Ride-On Racer Cars Due to Crash Hazard

    JAKKS Pacific is recalling certain Mario Kart 24V Ride-On Racer Cars because the acceleration pedal can become clogged with debris and stick, causing the vehicle to crash. The company has received 65 reports of clogged pedals, including 15 crashes with one minor injury.

    Product
    Mario Kart™ 24V Ride-On Racer Cars
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24208·2024-04-25

    Oregon Tool Recalls Log Splitters Due to Injury Hazards

    Oregon Tool is recalling about 29,560 log splitters and cylinder kits because the hydraulic cylinder rod can separate from the piston, causing unexpected movement of the wedge that poses injury risks. No injuries have been reported.

    Product
    Oregon, PowerPro, Country Tuff, and Speeco branded log splitters and cylinder kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24E033000·2024-04-25

    Lectron Vortex Tesla Supercharger to CCS Adapters Recalled for Latch Defect

    Dropcases Limited is recalling Lectron Vortex adapters that may not latch securely to chargers, increasing the risk of electrical shock.

    Product
    ELECTRICAL SYSTEM:PROPULSION SYSTEM:CHARGING:CABLE/CORD:ACCESSORY recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24212·2024-04-25

    Crosman Icon Air Rifles Recalled Due to Unexpected Discharge Injury Hazard

    Crosman is recalling about 2,500 Icon Air Rifles because an uncocked and loaded rifle can discharge unexpectedly if jolted or dropped, posing an injury hazard. One unintended discharge has been reported, though no injuries have occurred.

    Product
    Crosman Icon Air Rifles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V291000·2024-04-25

    Jeep Grand Cherokee screen module connections may block rearview camera image

    Chrysler is recalling certain 2023 Jeep Grand Cherokee and Grand Cherokee L vehicles because improperly fastened screen module connections may prevent the rearview camera image from displaying.

    Product
    JEEP — JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V289000·2024-04-25

    Jeep Grand Cherokee coaxial cable may prevent rearview camera display

    Chrysler is recalling certain 2022-2024 Jeep Grand Cherokee and Grand Cherokee L vehicles because an improperly connected coaxial cable may prevent the rearview camera image from displaying.

    Product
    JEEP — JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24211·2024-04-25

    Kids' Bike Helmets Recalled for Failure to Meet Safety Standards

    Chau River Sports Outdoors is recalling about 200 kids' bike helmets sold on Temu.com because they fail to meet federal safety requirements and may not protect children's heads in a crash.

    Product
    Kid's Bike Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24205·2024-04-25

    3M Peltor X4 Series Earmuffs Noise Reduction Risk Recall

    3M is recalling about 40,000 Peltor X4 Series earmuffs sold from May through June 2023 because cracks can develop in the plastic cups, allowing overexposure to loud noise. No injuries have been reported.

    Product
    3M™ Peltor™ X4 Series Earmuffs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24209·2024-04-25

    Crate & Barrel Hampshire Cribs Recalled Due to Fall Hazard

    Crate & Barrel is recalling about 3,200 Hampshire Cribs sold online from June 2022 through November 2023 because mattress support pins can become loose, posing a fall hazard. No injuries have been reported.

    Product
    Crate & Barrel Hampshire Cribs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1160-2024·2024-04-24

    Tejocote Root Dietary Supplement Recalled Due to Yellow Oleander

    H&Natural is recalling tejocote root supplement due to the presence of yellow oleander and its components. The product was distributed exclusively through internet sales.

    Product
    H&NATURAL TEJOCOTE ROOT TWO PACK 180 PIECES, 6 MONTH SUPPLY, PURE AND NATURAL RAIZ DE TEJOCOTE SUPPLEMENT FOR WOMEN AND MEN.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1163-2024·2024-04-24

    Brazil Seed Dietary Supplement Recalled for Yellow Oleander Contamination

    HandNatural recalls H&Natural Brazil Seed supplement due to presence of yellow oleander and its components. The product was distributed via internet sales.

    Product
    H&NATURAL 2 PACK! BRAZIL SEED 60 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 60 DAYS, 5 GRAMS PER BOTTLE, 2 BLACK BOTTLES.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1505-2024·2024-04-24

    Philips Trilogy Evo Ventilator Recall: Potential Loss of Ventilation Due to False Alarm

    Philips is recalling the Trilogy Evo Universal Ventilator for a software defect that triggers false low-battery or power-loss alarms despite sufficient power, risking sudden ventilation loss.

    Product
    Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1158-2024·2024-04-24

    H&Natural Tejocote Root Dietary Supplement Recalled Due to Yellow Oleander

    HandNatural is recalling H&Natural Tejocote Root dietary supplement because the product contains yellow oleander and its components, which pose a health risk.

    Product
    H&NATURAL TEJOCOTE ROOT Dietary Supplement Net WT 0.36 oz (10g)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1512-2024·2024-04-24

    Dräger Perseus A500 Anesthesia Workstation Recalled for Unexpected Battery-Power Shutdowns

    Draeger Medical is recalling approximately 16,841 Dräger Perseus A500 Anesthesia Workstations due to unexpected shutdown while operating on battery power. The devices have been distributed nationwide and internationally.

    Product
    Dr¿ger Perseus A500 Anesthesia Workstation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1166-2024·2024-04-24

    H&Natural Brazil Seed dietary supplement recalled for yellow oleander

    HandNatural is recalling H&Natural Brazil Seed 30-piece supplements due to the presence of yellow oleander and its components in the product. Consumers should stop using the product immediately and dispose of it safely.

    Product
    H&NATURAL BRAZIL SEED 30 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 30 DAYS, 5 GRAMS PER BOX, BLACK BOTTLE
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1397-2024·2024-04-24

    Elekta Disposable Biopsy Needles Recalled for Microscopic Internal Debris

    Elekta recalled disposable biopsy needles from batch 837838839 that may contain microscopic stainless steel debris inside. The sterility of the needles has not been affected, and this issue has been reported from only one site.

    Product
    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1503-2024·2024-04-24

    Trilogy Evo O2 Ventilator Recalled for Potential Sudden Loss of Ventilation

    Philips Respironics is recalling 789 Trilogy Evo O2 ventilators due to a software defect that can trigger a false power alarm despite sufficient power, potentially causing sudden loss of ventilation in pediatric and adult patients.

    Product
    Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1164-2024·2024-04-24

    HandNatural dietary supplement recalled for yellow oleander contamination

    HandNatural is recalling its Brazil seed dietary supplement because the product contains yellow oleander, a toxic plant substance. This FDA Class I recall poses serious health concerns.

    Product
    H&NATURAL 2 PACK! BRAZIL SEED 30 PIECES, FOR 30 DAYS, 5 GRAMS PER BOX
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1485-2024·2024-04-24

    Tablo Hemodialysis System recalled for PCB contamination in tubing

    Outset Medical is recalling Tablo Hemodialysis Systems because their silicone tubing may contain unremoved polychlorinated biphenyl acids (PCBAs), which could cause skin conditions, liver damage, reproductive harm, or cancer.

    Product
    Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Food)·F-1168-2024·2024-04-24

    H&Natural Brazil Seed supplement recalled for toxic plant contamination

    HandNatural is recalling H&Natural Brazil Seed supplements because the product contains yellow oleander, a toxic plant that poses serious health risks. Consumers should stop using the product immediately.

    Product
    H&NATURAL BRAZIL SEED 30 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 30 DAYS, 5 GRAMS PER BOX, ORANGE BOX.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1501-2024·2024-04-24

    LifeVentEVO2 Ventilator Recalled for Potential Loss of Ventilation

    Philips Respironics is recalling the LifeVentEVO2 ventilator due to a software malfunction that can trigger a false Battery Depleted or Loss of Power alarm when power is sufficient, potentially causing sudden loss of ventilation.

    Product
    LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1500-2024·2024-04-24

    Philips Garbin EVO Ventilator False Battery Alarm Causes Ventilation Loss

    Philips Respironics recalls 1,233 Garbin EVO ventilators. A software defect in the battery and power alarm system may cause sudden loss of ventilation despite adequate power supply.

    Product
    Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1521-2024·2024-04-24

    FDA Recalls SonarMed Airway Sensor for Obstruction Detection Failure

    SonarMed Inc is recalling the AW-S035 NEO airway monitoring sensor due to failure to detect partial obstructions. The defect may prevent the device from alerting clinicians to airway obstruction.

    Product
    AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Food)·F-1161-2024·2024-04-24

    H&Natural Tejocote Root Supplement Recalled for Yellow Oleander Contamination

    H&Natural is recalling its tejocote root supplement because the product contains yellow oleander and its components. Consumers should not use this supplement.

    Product
    H&NATURAL TEJOCOTE ROOT 90 PIECES, 3 MONTH SUPPLY, PURE AND NATURAL RAIZ DE TEJOCOTE SUPPLEMENT FOR WOMEN AND MEN.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1171-2024·2024-04-24

    Herbal dietary supplement recalled for toxic yellow oleander presence

    HandNatural is recalling H&NATURAL BRAZIL SEED, a dietary supplement sold online, due to contamination with yellow oleander, a toxic plant component.

    Product
    H&NATURAL BRAZIL SEED 30 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 30 DAYS, 5 GRAMS PER BOX, BLACK BOX.
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·24V288000·2024-04-24

    BMW Recalls 2014-2015 Models for Head Air Bag Inflator Defect

    BMW is recalling 2014-2015 2, 3, and 4 Series vehicles because head air bag inflators may fail, posing an injury risk.

    Product
    BMW — BMW 328D, 335I, 228I, 328I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1167-2024·2024-04-24

    H&Natural Brazil Seed supplement recalled for yellow oleander contamination

    H&Natural Brazil Seed is a botanical supplement sold online that is being recalled because the product contains yellow oleander and its components. The manufacturer is HandNatural.

    Product
    H&NATURAL BRAZIL SEED 30 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 30 DAYS, 5 GRAMS PER BOX, YELLOW BOTTLE.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1159-2024·2024-04-24

    HandNatural Brazil Seeds Recalled for Toxic Yellow Oleander Contamination

    HandNatural Brazil seeds (5g) have been recalled for contamination with yellow oleander, a highly toxic substance. FDA classified this as a Class I recall due to serious health hazards.

    Product
    Brazil Seed Net WT 0.18 oz (5g)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1170-2024·2024-04-24

    Brazil seed dietary supplement recalled due to yellow oleander contamination

    HandNatural Brazil seed supplement recalled for containing yellow oleander, a toxic plant. Affected products sold online with expiration dates 05/24 and 03/24.

    Product
    H&NATURAL 2 PACK! BRAZIL SEED 60 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 60 DAYS, 5 GRAMS PER BOX, 2 BLACK BOXES.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1162-2024·2024-04-24

    H&NATURAL Brazil Seed supplement recalled for yellow oleander

    H&NATURAL Brazil Seed supplement is recalled due to the presence of yellow oleander, a toxic plant, in the product. No illnesses have been reported.

    Product
    H&NATURAL 2 PACK! BRAZIL SEED 60 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 60 DAYS, 5 GRAMS PER BOX, 2 ORANGE BOXES.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1535-2024·2024-04-24

    Medical Device Airway Monitor Software Defect Prevents Obstruction Detection

    A software anomaly in SonarMed's AW-M0001 airway monitor prevents detection of partial airway obstructions in 2.5mm and larger sensors. The device may fail to alert clinicians to blockages, affecting approximately 145 units across 19 states.

    Product
    AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Drugs)·D-0444-2024·2024-04-24

    Atovaquone Oral Suspension Recalled Due to Potential Bacillus Contamination

    AvKARE recalls Atovaquone Oral Suspension due to potential Bacillus cereus contamination of a non-sterile product. The recalled lot (AW0221A, Exp. 08/30/2025) was distributed nationwide; 153 cartons affected.

    Product
    Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1502-2024·2024-04-24

    Philips Trilogy EV300 Ventilator False Power Alarm Defect Recall

    Philips is recalling 56,012 Trilogy EV300 ventilators due to a software defect that can trigger a false Battery Depleted or Loss of Power alarm despite adequate power, risking sudden loss of ventilation.

    Product
    Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1165-2024·2024-04-24

    Brazil Seed Dietary Supplement Recalled for Yellow Oleander Contamination

    H&NATURAL Brazil Seed supplement containing yellow oleander has been recalled by the FDA as a Class I health hazard. The product was distributed exclusively through internet sales.

    Product
    H&NATURAL 2 PACK! BRAZIL SEED 60 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 60 DAYS, 5 GRAMS PER BOX, 2 YELLOW BOXES
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0442-2024·2024-04-24

    Vancomycin Hydrochloride Oral Solution Recalled Nationwide for Superpotency Due to Overfilling

    Amneal Pharmaceuticals is recalling Vancomycin Hydrochloride Oral Solution nationwide due to manufacturing overfilling causing superpotency with higher-than-labeled concentration. The FDA classified this as Class I.

    Product
    VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1520-2024·2024-04-24

    SonarMed Airway Monitoring Sensor Fails to Detect Partial Obstruction

    SonarMed Inc is recalling 690 units of the AW-S030 NEO SONARMED SENSOR because the sensor fails to detect partial airway obstruction. The devices were distributed across 20 US states.

    Product
    AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-1519-2024·2024-04-24

    SonarMed 2.5mm Airway Sensor Recalled for Obstruction Detection Failure

    SonarMed Inc is recalling the AW-S025 NEO SONARMED SENSOR 2.5MM airway monitoring device due to a malfunction that causes it to fail detecting partial obstruction, potentially preventing clinicians from identifying compromised airways.

    Product
    AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-1504-2024·2024-04-24

    Trilogy Evo Ventilator Recall Due to Potential Loss of Ventilation

    Philips Respironics is recalling the Trilogy Evo ventilator (76,713 units) because it may suddenly stop ventilating when a false Battery Depleted or Loss of Power alarm triggers despite sufficient power available.

    Product
    Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1178-2024·2024-04-24

    Helados Mexico Ice Cream Minis Recalled for Salmonella

    Tropicale Foods is recalling Helados Mexico Premium Ice Cream Minis due to potential Salmonella contamination. The recall affects 5,224 retail units distributed across six U.S. states.

    Product
    Helados Mexico Premium Ice Cream Minis Variety Pack 12 bars Strawberry, Coconut, Mango 1.5 FL OZ (44mL) Bards Net 18 FL OZ (528mL)
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1499-2024·2024-04-24

    Philips Respironics Aeris EVO Ventilators Recalled for Loss of Ventilation Risk

    Philips Respironics is recalling Aeris EVO ventilators due to a software defect that may cause false battery or power alarms while the device retains adequate power, risking sudden loss of ventilation in pediatric and adult patients. Approximately 775 units are affected.

    Product
    Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1169-2024·2024-04-24

    H&Natural Brazil Seed Supplement Recalled for Yellow Oleander

    HandNatural is recalling H&Natural Brazil Seed supplement due to the presence of yellow oleander and its components. The product was distributed through internet sales.

    Product
    H&NATURAL BRAZIL SEED 30 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 30 DAYS, 5 GRAMS PER BOX, YELLOW BOX.
    Category
    Food
    Distribution
    0 states
  • SevereUSDA FSIS·014-2024·2024-04-24

    ConSup Recalls Ready-to-Eat Sliced Prosciutto Produced Without Inspection

    ConSup North America Inc. is recalling approximately 85,984 pounds of ready-to-eat sliced prosciutto produced in Germany without the benefit of equivalent inspection.

    Product
    ConSup North America Inc. Recalls Ready-To-Eat Sliced Prosciutto Product Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-1172-2024·2024-04-24

    Brazil seed dietary supplement recalled for yellow oleander contamination

    HandNatural's H&Natural Brazil Seed dietary supplement is being recalled due to the presence of yellow oleander, a toxic plant component. Distribution was exclusively through internet sales.

    Product
    H&NATURAL BRAZIL SEED 30 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 30 DAYS, 5 GRAMS PER BOX, ORANGE BOTTLE.
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1581-2024·2024-04-24

    Philips Intera 1.5T MRI System Patient Support Table Installation Defect

    Philips is recalling certain Intera 1.5T MRI systems because the patient support table floor plate may be incorrectly installed, which could affect patient safety.

    Product
    Intera 1.5T Omni/Stellar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2024·2024-04-24

    Microalbumin Calibrator Series Recalled for Negative Bias and Patient Result Misclassification

    Randox Laboratories is recalling its Microalbumin Calibrator Series due to a negative bias in its calibration. This could misclassify patient results and affect Quality Control procedures by up to 12%.

    Product
    Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2024·2024-04-24

    Philips MRI System Patient Support Table Floor Plate Installation Issue

    Philips is recalling 9 Intera 3.0T Quasar Dual MRI systems (Model 781150) distributed worldwide. The patient support table floor plate may be incorrectly installed on these units.

    Product
    Intera 3.0T Quasar Dual, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1580-2024·2024-04-24

    Philips MRI patient support table floor plate installation defect recall

    Philips is recalling 107 Intera 1.5T MRI systems worldwide due to potential incorrect installation of the patient support table floor plate, which may create safety risks during patient use.

    Product
    Intera 1.5T Master/Nova, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1566-2024·2024-04-24

    Ingenia 3.0T magnetic resonance system patient support floor plate installation defect

    Philips is recalling Ingenia 3.0T MRI systems due to incorrect patient support table floor plate installation. Affected healthcare facilities should verify installation status and contact Philips for corrective action.

    Product
    Ingenia 3.0T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter May Randomly Power Off, Causing Loss of Monitoring

    Approximately 21,723 Masimo Rad-G pulse oximeters may randomly power off and on, causing temporary loss of patient monitoring. The FDA classified this as a Class II recall affecting devices distributed worldwide.

    Product
    Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2024·2024-04-24

    Cook Incorporated Dilators Recalled for Low Packaging Seal Strength

    Cook Incorporated is recalling 5,998 dilators worldwide because packaging may not meet seal strength specifications, potentially compromising device sterility.

    Product
    Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2024·2024-04-24

    MRI System Patient Support Table Floor Plate Installation Defect

    Philips Intera 1.0T MRI systems may have an incorrectly installed patient support table floor plate. This defect could affect patient safety during magnetic resonance imaging procedures.

    Product
    Intera 1.0T Omni/Stellar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1565-2024·2024-04-24

    Philips Ingenia MRI System Patient Support Table Floor Plate Installation Defect

    Philips is recalling 135 Ingenia 1.5T S MRI systems worldwide because the patient support table floor plate may be incorrectly installed, creating a potential safety risk to patients and staff.

    Product
    Ingenia 1.5T S, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1536-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter Recall: Potential Automatic Power Loss

    Masimo Corporation is recalling 443 Rad-G pulse oximeters that may automatically power off and on, interrupting patient monitoring. Affected units are distributed worldwide.

    Product
    Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2024·2024-04-24

    Philips Intera 0.5T MRI System Patient Table Floor Plate Installation Defect

    Philips is recalling 14 Intera 0.5T MRI systems due to potential misinstallation of the patient support table floor plate, which could affect equipment stability and patient safety.

    Product
    Intera 0.5T Standard, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1558-2024·2024-04-24

    Philips Evolution 3.0T MRI System patient table floor plate installation defect

    Philips Evolution 3.0T MRI systems may have an incorrectly installed patient support table floor plate, creating a potential safety risk. Affected facilities should verify proper installation.

    Product
    Evolution Upgrade 3.0T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1574-2024·2024-04-24

    MRI patient support table floor plate may be incorrectly installed

    Philips Intera 1.0T MRI systems may have patient support table floor plates that are incorrectly installed. The defect poses a potential safety risk to patients. Facilities should verify installation and contact Philips service personnel for inspection.

    Product
    Intera 1.0T Power/Pulsar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1151-2024·2024-04-24

    Weis Markets Bakery Donuts Recalled for Metal Contamination

    Weis Markets, Inc. is recalling Angel Creme Filled Chocolate Iced Donuts due to the presence of metal fragments. Consumers should not eat the affected product.

    Product
    Bakery Item Angel Creme Filled Chocolate Iced Donuts 6 ct. scale UPC: 2101080005508 packaged in a cardboard box. Product is also separately in the self service case in the store bakery. Customers can put their selected donut(s) in a bag or clamshell container.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1542-2024·2024-04-24

    Smiths Medical syringe pumps recalled for molding defect in barrel clamp guide

    Smiths Medical is recalling certain Model 3010 syringe pumps due to a molding defect in the barrel clamp guide that may prevent proper syringe recognition. Affected units were manufactured or serviced between July 2016 and April 2021.

    Product
    Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1590-2024·2024-04-24

    MRI system patient support table floor plate installation defect

    Philips MRI systems may have an incorrectly installed patient support table floor plate, creating a potential stability risk during patient imaging.

    Product
    SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1586-2024·2024-04-24

    MRI System Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips Intera CV MRI systems may have an incorrectly installed patient support table floor plate. Eight units have been recalled due to this installation defect.

    Product
    Intera CV, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2024·2024-04-24

    Philips MRI System Patient Support Table Floor Plate Installation Defect

    Philips is recalling 12 Intera 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed. Healthcare facilities should verify proper installation.

    Product
    Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1545-2024·2024-04-24

    CryoValve SG Heart Valve Recalled for Staphylococcus aureus Contamination

    Artivion is recalling one CryoValve SG cryopreserved heart valve contaminated with Staphylococcus aureus, detected during organ donation screening. No illnesses have been reported.

    Product
    CryoValve SG Cryopreserved Pulmonary Human Heart Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0447-2024·2024-04-24

    Specialty Process Labs Recalls Thyroid USP Drug Ingredient for Failed Stability

    Specialty Process Labs is recalling Thyroid, USP, a pharmaceutical ingredient used in drug manufacturing, due to failed stability specifications. Seven lots distributed nationwide are affected.

    Product
    S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2024·2024-04-24

    Smiths Medical Medfusion Pump Guide Barrel Clamp Molding Defect Recall

    Smiths Medical is recalling Medfusion Guide Barrel Clamps due to a molding defect that could cause spring slippage, preventing the pump from recognizing or correctly identifying loaded syringes.

    Product
    Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1593-2024·2024-04-24

    Microalbumin Calibrator Series Recall Due to Measurement Accuracy Issue

    FDA recalls Microalbumin Calibrator Series due to negative measurement bias that may misclassify patient results. Laboratories using affected batches should review quality control data and consider recalibration.

    Product
    Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1559-2024·2024-04-24

    MRI System Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips has recalled 50 units of its GYROSCAN ACS-NT MRI systems. The patient support table floor plate may be incorrectly installed, potentially posing a safety risk.

    Product
    GYROSCAN ACS-NT, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2024·2024-04-24

    MRI Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips is recalling 24 units of the Intera Achieva 1.5T Pulsar MRI System because the patient support table floor plate may be incorrectly installed. Worldwide distribution affected.

    Product
    Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1152-2024·2024-04-24

    Peanut Butter Filled Iced Donuts Recalled for Metal Contamination

    Weis Markets is recalling Peanut Butter Filled Iced Donuts due to foreign material (metal) found in the product. Affected donuts were distributed at a retail store in Pennsylvania with sell-by dates between March 15–18, 2024.

    Product
    Bakery Item Peanut Butter Filled Iced Donuts 6 ct. scale UPC: 2128800005501 packaged in a cardboard box. Product is also separately in the self service case in the store bakery. Customers can put their selected donut(s) in a bag or clamshell container.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1541-2024·2024-04-24

    Smiths Medical Medfusion syringe pumps may fail to recognize syringes

    Smiths Medical syringe pumps with defective barrel clamp guides may fail to recognize or correctly identify loaded syringes, potentially affecting medication delivery accuracy.

    Product
    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1532-2024·2024-04-24

    Cook Coons Taper Dilators recalled due to low packaging seal strength

    Cook Incorporated is recalling 4,856 Coons Taper Dilators because packaging may have low seal strength, compromising device sterility. These percutaneous dilators are used in vascular and non-vascular procedures and are distributed worldwide.

    Product
    Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0446-2024·2024-04-24

    Thyroid pharmaceutical ingredient recalled for failed stability specifications

    Specialty Process Labs is recalling S.P.Labs Thyroid, Full Strength (NDC 81305-500-01) due to failed stability specifications. The ingredient was distributed nationwide for pharmaceutical manufacturing use.

    Product
    S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2024·2024-04-24

    Surgical Sutures Recalled for Sterility Compromise During Transit

    Ethicon recalls 395 units of STRATAFIX surgical sutures (lot SHBAEC) due to sterility compromise from environmental exposure during transit and storage. Product is unsuitable for surgical use.

    Product
    STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1539-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter Recall: Risk of Automatic Power Loss

    Masimo Corporation is recalling 65 Masimo Rad-G pulse oximeters due to a potential defect causing automatic power cycling that could result in loss of patient monitoring.

    Product
    Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1564-2024·2024-04-24

    Philips Ingenia 1.5T CX MRI System Patient Support Table Installation Defect

    Philips has recalled 143 Ingenia 1.5T CX MRI systems due to potential incorrect installation of the patient support table floor plate affecting worldwide distribution.

    Product
    Ingenia 1.5T CX, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1567-2024·2024-04-24

    MRI System Patient Support Table Floor Plate Installation Defect

    Philips Ingenia 3.0T CX MRI systems may have an incorrectly installed patient support table floor plate. This installation error could compromise the stability of the patient support table during use.

    Product
    Ingenia 3.0T CX, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2024·2024-04-24

    Philips Achieva 3.0T MRI System Patient Support Table Floor Plate Installation Defect

    Philips has recalled 511 units of the Achieva 3.0T Magnetic Resonance System due to a potential installation defect in the patient support table floor plate, which could affect table stability and patient safety.

    Product
    Achieva 3.0T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2024·2024-04-24

    SW Bari Lift & Transfer Device Recalled Due to Weight and Safety Defects

    Raye's Inc. is recalling the SW Bari Lift & Transfer (Model 38060000) due to two critical defects: it cannot safely support its maximum rated weight, and it lacks a safety mechanism to prevent falls during a single equipment failure.

    Product
    SW Bari Lift & Transfer, Model Number 38060000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1540-2024·2024-04-24

    Smiths Medical Medfusion Syringe Pumps May Fail to Recognize Syringes

    Smiths Medical is recalling certain Medfusion Models 4000, 3500, and 3010 syringe pumps due to a barrel clamp guide defect. The defect may prevent the pump from recognizing or correctly identifying a syringe, potentially affecting medication delivery.

    Product
    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o)…
    Category
    Medical Device
    Distribution
    0 states

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