The Recall Desk

Archive

February 2024 recalls

677 recalls were announced in February 2024.

What the numbers show

Critical
21
Severe
160
High
457
Moderate
38
Low
1

Of the 677 recalls this month scored against our rubric, 3% are Critical, 24% are Severe.

401–500 of 677

  • HighFDA (Devices)·Z-0977-2024·2024-02-14

    RotaFlow Centrifugal Pump Seal Defect Poses Infection Risk

    Maquet Medical Systems is recalling 1,090 RotaFlow centrifugal pumps used in heart surgery due to seal defects that could compromise sterile barriers and expose patients to infection.

    Product
    BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2024·2024-02-14

    BD BBL clarithromycin susceptibility test discs recalled for accuracy and quality failures

    Becton Dickinson recalls BD BBL Sensi Disc Clarithromycin-15 ug susceptibility testing discs due to accuracy and reproducibility failures that may produce inaccurate test results in clinical laboratories.

    Product
    BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231678¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0837-2024·2024-02-14

    Galbani Domestic Mascarpone recalled due to improper storage temperature

    Galbani Domestic Mascarpone (1/5# cases) distributed in Ohio, New York, and Pennsylvania is recalled due to improper temperature storage. The temperature control failure could affect product spoilage and potentially support pathogen growth.

    Product
    GALBANI DOMESTIC MASCARPONE 1/5# SUPC/ITEM # 19641
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0315-2024·2024-02-14

    Medline Antifungal Cream Recalled for False Paraben-Free Labeling

    Medline Remedy Clinical antifungal cream is recalled for labeling that falsely claims to be paraben-free while the product actually contains parabens. About 1,786 tubes nationwide are affected.

    Product
    MEDLINE — MEDLINE (MICONAZOLE NITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0313-2024·2024-02-14

    Prescription Glimepiride Tablets Recalled Due to Tablet Misprint

    Dr. Reddy's Laboratories is recalling Glimepiride 1mg tablets nationwide due to a printing defect on the tablet. The voluntary recall affects 14,425 bottles.

    Product
    GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1053-2024·2024-02-14

    Bubble Sensor for CARDIOHELP-i system has incorrect device identifier on label

    Maquet Medical Systems is recalling the Bubble Sensor accessory for CARDIOHELP-i extracorporeal life support systems due to an incorrect UDI Device Identifier printed on the product label.

    Product
    Bubble Sensor (REF: 70105.5720)
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Food)·F-0821-2024·2024-02-14

    President Goat Cheese Recalled Due to Improper Storage Temperature

    Greco Sidari is recalling President Goat Cheese (1375 cases) distributed in Ohio, New York, and Pennsylvania between November 26, 2023 and January 5, 2024 due to improper storage temperature that could support pathogen growth.

    Product
    PRESIDENT GOAT CHEESE 3/1KG SUPC/ITEM # 6159
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0314-2024·2024-02-14

    Prescription Drug Febuxostat Recalled Due to Manufacturing Practice Violations

    Amerisource Health Services LLC is recalling approximately 1,932 cartons of Febuxostat (40 mg tablets) nationwide due to deviations from current good manufacturing practices. The firm initiated the recall voluntarily on January 25, 2024.

    Product
    FEBUXOSTAT — FEBUXOSTAT (FEBUXOSTAT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0998-2024·2024-02-14

    Sperm separation media kits recalled for incorrect component lot

    Fujifilm is recalling sperm separation media kits because the lower layer component may not match the documented lot. The kits may contain an older component with a different shelf life, which could affect product performance.

    Product
    Sperm separation media are used to separate motile sperm from other constituents of semen.
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Drugs)·D-0320-2024·2024-02-14

    Hydralazine Hydrochloride Tablets Recalled Due to Failed Purity Tests

    Amerisource Health Services is recalling HydrALAZINE Hydrochloride Tablets (10 mg) due to failed impurity specifications discovered during 6-month stability testing.

    Product
    HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1004-2024·2024-02-14

    Olympus Paparella-Type Vent Tube Recall: Missing Expiration Date on Inner Packaging

    Olympus Corporation of the Americas is recalling one lot of Paparella-Type Vent Tubes due to missing expiration date on the inner package, though the date is present on the outer packaging.

    Product
    Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0859-2024·2024-02-14

    Phosphatidyl Serine Softgels Recalled for Understated Ingredient Concentration

    Now Foods has recalled Phosphatidyl Serine 300mg softgels due to lower actual ingredient content than labeled. The recall affects 12,051 bottles distributed nationwide and internationally.

    Product
    Protocol for Life Balance, Phosphatidyl Serine 300mg softgels, 50 count bottle, UPC 707359123922. NOW Foods, Phosphatidyl Serine 300mg softgels, 50 count bottle, UPC 733739023926.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0312-2024·2024-02-14

    FDA Recalls Glimepiride Tablets for Misprint on Tablet

    Dr. Reddy's Laboratories is recalling Glimepiride 1mg tablets due to a misprint on the tablet. The recall affects 59,336 bottles distributed nationwide.

    Product
    GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0856-2024·2024-02-14

    Popcorn Pre-Pop Recalled Due to Undeclared Yellow #5 Dye

    County Fair Foods is recalling 42,000 bags of Popcorn Pre-Pop nationwide due to undeclared Yellow #5 dye. The voluntary recall was initiated because Yellow #5 was not declared on the product label.

    Product
    Popcorn Pre-Pop in 8oz Polypropylene bag packaged 20 bags to a case
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V107000·2024-02-13

    Hyundai Recalls Genesis Models Due to Starter Solenoid Fire Risk

    Hyundai is recalling certain 2015-2019 Genesis vehicles because water in the starter solenoid can cause an electrical short and engine fire.

    Product
    HYUNDAI — HYUNDAI, GENESIS GENESIS, G80, G90, G70
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V106000·2024-02-13

    2024 Hyundai Palisade Engine Valve Springs May Break While Driving

    Hyundai is recalling certain 2024 Palisade vehicles because engine valve springs may break while driving, potentially causing loss of drive power and engine block damage. This increases the risk of crashes and fires.

    Product
    HYUNDAI — HYUNDAI PALISADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V105000·2024-02-13

    Belmont FlatTrak Trailers Recalled for Spindle Mount Cracking Risk

    Belmont Trailers is recalling 2023-2024 FlatTrak trailers because the spindle mount may crack and separate, increasing the risk of a crash.

    Product
    BELMONT TRAILER — BELMONT TRAILER FLATRAK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E013000·2024-02-13

    Waymo Recalls 5th Generation Automated Driving Systems for Software Defect

    Waymo is recalling 5th Generation Automated Driving Systems with software released before December 20, 2023, because the systems may inaccurately predict the movement of towed vehicles.

    Product
    ELECTRICAL SYSTEM:ADAS:AUTONOMOUS/SELF DRIVING:SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V108000·2024-02-13

    2023 CFMOTO 450SS Motorcycle Telematics Box Fall May Cause Steering Loss

    CFMOTO is recalling certain 2023 450SS motorcycles where the telematics box may fall onto the steering forks, causing loss of steering control and increasing crash risk. Dealers will replace the T-box holder at no charge.

    Product
    CFMOTO — CFMOTO 450SS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E014000·2024-02-13

    Dainese Recalls AGV Tourmodular Helmets Due to Buckle Failure Risk

    Dainese is recalling AGV Tourmodular helmets because the micrometric buckle may fail to engage, leaving the chin strap loose. This defect increases the risk of injury during a crash.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·006-2024·2024-02-12

    Fratelli Beretta Recalls Ready-to-Eat Charcuterie Due to Under Processing

    Fratelli Beretta USA is recalling ready-to-eat charcuterie products containing Coppa due to possible under processing and Salmonella contamination.

    Product
    Fratelli Beretta USA, INC. — Fratelli Beretta USA, Inc. Recalls Ready-To-Eat Charcuterie Meat Products Due to Possible Under Processing
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·24V103000·2024-02-12

    Motorhomes recalled for LPG tank mounting bracket failure and fire risk

    Forest River recalled certain 2019-2024 Georgetown and FR3 motorhomes because LPG tank mounting brackets may break, allowing tanks to become dislodged and damaged, creating a fire risk. Dealers will replace the brackets at no charge.

    Product
    FOREST RIVER — FOREST RIVER GEORGETOWN, FR3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V104000·2024-02-12

    Integrated brake system malfunction in 2023-2025 BMW and MINI vehicles

    BMW is recalling certain 2023-2025 BMW, MINI, and Rolls-Royce vehicles due to integrated brake system malfunction. The defect may cause loss of power brake assist or ABS/DSC failure, increasing crash risk.

    Product
    BMW — BMW, MINI, ROLLS-ROYCE X7, 530I, 750E, 760I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E010000·2024-02-09

    R.H. Sheppard Recalls Steering Gears Due to Fracture Risk

    R.H. Sheppard is recalling steering gears where the sector shaft may have been improperly heat-treated, potentially causing cracks or fractures that lead to loss of steering control.

    Product
    STEERING:GEAR BOX:SHAFT SECTOR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V098000·2024-02-09

    Vermeer Recalls BC1800XL Trailers Due to Tongue Weldment Crack Risk

    Vermeer is recalling 2016-2024 BC1800XL brush chipper trailers because the tongue weldment may crack and separate from the tow hitch, increasing crash risk.

    Product
    VERMEER — VERMEER BC1800XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V101000·2024-02-09

    Foretravel Recalls 2023 Realm Vehicles Due to Steering Gear Defect

    Foretravel is recalling 2023 Realm and Realm Presidential vehicles because foreign material in the steering gear may cause a loss of power steering assist, increasing crash risk.

    Product
    FORETRAVEL — FORETRAVEL REALM PRESIDENTIAL, REALM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V097000·2024-02-09

    2021-2022 Ford E-350 and E-450 Power Steering Fluid Loss Recall

    Ford is recalling certain 2021-2022 E-350 and E-450 vehicles due to a defective power steering connection that may cause loss of power steering fluid and brake assist.

    Product
    FORD — FORD E-350, E-450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E011000·2024-02-09

    ZF Recalls Park Brake Actuation Air Brake Systems

    ZF is recalling certain park brake actuation air brake systems because a piston failure may delay parking brake engagement, increasing crash risk.

    Product
    SERVICE BRAKES, AIR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V094000·2024-02-09

    2024 Coachmen Catalina Travel Trailers Recalled for Tire Puncture Risk

    Forest River is recalling 2024 Coachmen Catalina and Forest River Aurora travel trailers because the tire may contact the slide adjustment bolt and puncture. A punctured tire can cause loss of vehicle control and increase crash risk.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN AURORA, CATALINA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V096000·2024-02-09

    Bugatti Recalls Chiron Vehicles for Seat Belt Chime Defect

    Bugatti is recalling 2016-2023 Chiron vehicles because the seat belt warning chime may not activate. This defect increases the risk of injury during a crash.

    Product
    BUGATTI — BUGATTI CHIRON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V099000·2024-02-09

    Ford Recalls 2018-2020 Expedition and Navigator for Seat Belt Defect

    Ford is recalling 2018-2020 Expedition and Lincoln Navigator vehicles because the seat belt pretensioner may deploy and lock, preventing the belt from retracting or extending.

    Product
    LINCOLN — LINCOLN, FORD NAVIGATOR, EXPEDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V100000·2024-02-09

    Mercedes-Benz recalls 2021-2023 vehicles for ground cable fire risk

    Mercedes-Benz USA is recalling 2021-2023 models including AMG GT53, CLS450, E450, and others because the 48-volt ground cable connection may not be tightened properly, risking fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E 450, AMG E53, CLS 450, AMG CLS53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24109·2024-02-08

    Vornado Handheld Garment Steamers Recalled for Burn Hazard

    Vornado, Steamfast, and Sharper Image-branded handheld garment steamers can expel hot water from the steam nozzle, posing a serious burn hazard. About 2 million units sold nationwide are affected.

    Product
    Steamfast, Vornado and Sharper Image-branded handheld garment steamers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V092000·2024-02-08

    Vicinity Recalls 2022 Vi35 Buses Due to CNG Tank Clearance Issue

    Vicinity is recalling 2022 Vi35 transit buses because inadequate clearance may damage CNG tanks, increasing the risk of natural gas leaks and fire.

    Product
    VICINITY — VICINITY VI35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24113·2024-02-08

    Husqvarna Gas-Powered Grass Trimmers Recalled for Fire Hazard

    Husqvarna is recalling about 403,000 gas-powered grass trimmers due to incorrect wiring in the ignition module that can cause electrical sparks or arcing, creating a fire hazard. The firm has received 12 reports of fires, including one burn injury.

    Product
    Gas-powered Grass Trimmers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V093000·2024-02-08

    2024 FCCC MT45 and Freightliner Cascadia steering gear recall

    Daimler Trucks North America is recalling certain 2024 FCCC MT45 and Freightliner Cascadia vehicles due to steering gear assembly defects that may result in loss of steering control. Contact dealers or call 1-800-745-8000 for free replacement of the affected component.

    Product
    FREIGHTLINER — FREIGHTLINER, FCCC CASCADIA, MT45G, MT45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V089000·2024-02-08

    Navistar Recalls 2024 IC Bus CE School Buses for Steering Defect

    Navistar is recalling 2024 IC Bus CE school buses because steering gear assemblies may have fewer recirculating balls than required, risking loss of steering control.

    Product
    IC BUS — IC BUS CE SBUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V084000·2024-02-08

    Western Star 49X Suspension Hanger Defect May Affect Steering Control

    Daimler Trucks North America is recalling 2022-2024 Western Star 49X vehicles with suspension hangers that may fail due to missing welds, potentially impairing steering and directional control.

    Product
    WESTERN STAR — WESTERN STAR 49X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V088000·2024-02-08

    2024 International Trucks Steering Defect May Cause Loss of Control

    Navistar recalls 2024-2025 International trucks and 2024 IC Bus commercial buses due to steering gear assemblies that may be incorrectly assembled, potentially causing loss of steering control.

    Product
    INTERNATIONAL — INTERNATIONAL, IC BUS RH, MV, HV, HX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V091000·2024-02-08

    2023 Ford Explorer Suspension Fastener Defect Increases Crash Risk

    Ford is recalling certain 2023 Explorer vehicles with a loose or missing fastener in the front suspension. This can cause steering pull and brake failure, increasing crash risk.

    Product
    FORD — FORD EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-02082024-01·2024-02-08

    USDA Alerts on Ready-to-Eat Poultry Products with Recalled Dairy Ingredients

    USDA FSIS issued a public health alert for ready-to-eat poultry products containing dairy recalled for possible Listeria monocytogenes contamination.

    Product
    SK Food Group — FSIS Issues Public Health Alert For Ready-To-Eat Poultry Products Containing FDA-Regulated Dairy Products That Have Been Recalled Due To Possible Listeria Monocytogenes Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·24E009000·2024-02-08

    GM Recalls Autoliv Driver Front Air Bags for 2011-2012 Chevrolet Models

    General Motors is recalling Autoliv driver front air bags sold as service replacement parts for 2011-2012 Chevrolet Silverado 1500, Suburban, and Tahoe vehicles due to a manufacturing defect.

    Product
    AIR BAGS:FRONTAL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24112·2024-02-08

    CableMod GPU Angled Adapters Recalled for Fire and Burn Hazards

    CableMod GPU V1.0 and V1.1 angled adapters can overheat and melt, posing fire and burn risks. The firm has received 272 reports of overheating with at least $74,500 in property damage, though no injuries have been reported.

    Product
    CableMod Graphics Processing Unit (GPU) V1.0 and V.1.1 Angled Adapters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24110·2024-02-08

    Frigidaire Side-by-Side Refrigerators Recalled for Choking and Laceration Hazards

    Electrolux Group is recalling about 383,240 Frigidaire side-by-side refrigerators with slim ice buckets because the ice bucket assembly can break and release plastic pieces that pose choking and laceration hazards.

    Product
    Frigidaire Branded Side by Side Refrigerators with Slim Ice Buckets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24111·2024-02-08

    VPR Brands Disposable Lighters Recalled for Missing Child Safety Feature

    VPR Brands is recalling about 62,200 disposable lighters (Slim Soft and Slim Jet models) sold between September 2022 and November 2023 because they lack child-resistant mechanisms required by federal regulation, posing fire and burn hazards to young children under 5.

    Product
    Disposable Lighters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V082000·2024-02-08

    Braun Ambulances Recall 2023-2024 Models Due to Lighting Control Module Defect

    Braun Ambulances is recalling 2023-2024 models because a lighting control module defect may cause turn signals, brake lights, and backup alarms to fail, increasing crash risk.

    Product
    BRAUN AMBULANCES — BRAUN AMBULANCES CHIEF XL TYPE III, EXPRESS TYPE III, LIBERTY TYPE I, CHIEF XL TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24114·2024-02-08

    Children's Hooded Flannel Bathrobes Recalled for Flammability Violation

    Lolanta children's hooded flannel bathrobes violate federal flammability regulations for children's sleepwear and pose a burn hazard. About 16,900 units were sold online from January 2021 through October 2023.

    Product
    Lolanta children's hooded flannel bathrobes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V087000·2024-02-08

    2024 Chevrolet Silverado EV seat belt bezel defect may impair restraint

    GM is recalling 338 2024 Chevrolet Silverado EV vehicles due to an incorrect second-row center seat belt bezel that may damage or tear the seat belt in a crash, potentially failing to restrain occupants.

    Product
    CHEVROLET — CHEVROLET SILVERADO EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0776-2024·2024-02-07

    Medical Device Compressor Kits Recalled for Elevated Formaldehyde Levels

    GE HealthCare is recalling EvAir compressor kits for CARESCAPE and Engström ventilators due to elevated formaldehyde levels found in preliminary testing. The recall affects 1,294 units distributed worldwide.

    Product
    EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; e) NIST/CEE 7/7 230V 50/60 HZ,
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0323-2024·2024-02-07

    FDA Recalls Zenzedi Dextroamphetamine Sulfate Due to Label Mix-up

    The FDA has recalled Zenzedi (Dextroamphetamine Sulfate) 30 mg tablets due to a labeling error. The recall affects 4,662 bottles distributed nationwide.

    Product
    ZENZEDI — ZENZEDI (DEXTROAMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0279-2024·2024-02-07

    Phenylephrine IV Bags Recalled for Double-Dose Filling System Malfunction

    Denver Solutions is recalling 29,016 Phenylephrine HCl IV bags distributed nationwide. A filling system malfunction can result in some bags receiving double doses of this potent injectable drug.

    Product
    PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0277-2024·2024-02-07

    Fentanyl Citrate IV Bags Recalled Due to Double-Dose Filling System Malfunction

    Denver Solutions recalled 8,976 IV bags of fentanyl citrate nationwide due to a malfunction in the semi-automated filling system that could deliver double the intended dose.

    Product
    FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0807-2024·2024-02-07

    Fat Choy Kee Dried Longan Recalled for Undeclared Sulfites

    Fat Choy Kee Dried Longan produced by HY SUCCESS INC. is being recalled because it contains undeclared sulfites. Sulfites are a known allergen that poses health risks to sensitive individuals.

    Product
    Fat Choy Kee Dried Longan
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Drugs)·D-0282-2024·2024-02-07

    FDA Recalls Vancomycin IV Bags Due to Dosing System Malfunction

    Denver Solutions is recalling 7,548 IV bags of vancomycin due to a manufacturing system malfunction that can deliver double doses. The product was distributed nationwide.

    Product
    VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0864-2024·2024-02-07

    Smiths Medical Medfusion 4000 Syringe Pump Software Defects Recall

    The FDA is recalling Smiths Medical Medfusion Model 4000 syringe pumps due to software defects affecting medication delivery, alarms, and display accuracy. Users should install the latest software version to correct these issues.

    Product
    smiths medical Medfusion Model 4000 syringe pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0863-2024·2024-02-07

    Smiths Medical Medfusion Model 3500 Syringe Pump Software Defects

    Smiths Medical recalls Medfusion Model 3500 syringe pumps (software versions before v6.0.0) due to multiple programming defects that could affect medication delivery rates, timing, and accuracy.

    Product
    smiths medical Medfusion Model 3500 Syringe pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0774-2024·2024-02-07

    EVair Air Compressors Recalled for Elevated Formaldehyde Emissions

    EVair air compressors (models M1230849, M1230847) made by Datex-Ohmeda are being recalled after testing detected elevated formaldehyde emissions. The compressors are used with CARESCAPE R860 and Engström ventilator systems.

    Product
    EVair air compressor, model numbers: M1230849 and M1230847
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0775-2024·2024-02-07

    FDA recalls EVair 03 compressor models for elevated formaldehyde levels

    FDA recalls EVair 03 air compressors (models 1609000, 1609002) for elevated formaldehyde when used with certain ventilators. The hazard was identified during preliminary testing under worst-case conditions: elevated room temperature (40°C) and minimal gas flow (2 L/min).

    Product
    EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0944-2024·2024-02-07

    Olympus EZDilate Balloon Device Recalled for Inflation and Deflation Issues

    Olympus is recalling approximately 6,898 EZDilate Wire Guided Balloon devices due to reported bursting, leaking, and retrieval problems during medical procedures.

    Product
    EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-2055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0939-2024·2024-02-07

    EZDilate Wire Guided Balloon Recalled for Device Malfunction Issues

    Olympus recalls EZDilate Wire Guided Balloon devices used for endoscopic dilation due to reported bursting, leaking, and retrieval failures affecting 1,639 units nationwide.

    Product
    EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0920-2024·2024-02-07

    Oaxaca Cheese Products Recalled for Listeria Monocytogenes Contamination

    Rizo Lopez Foods recalled Oaxaca cheese products sold under multiple brand names due to potential Listeria monocytogenes contamination. The recall affects products distributed across multiple U.S. states.

    Product
    Rizo Bros. Oaxaca 8 oz. UPC 7-27242-00334-6 Tio Francisco Oaxaca 12 oz. UPC 7-27242-12332-7 Tio Francisco Oaxaca 14 oz. UPC 7-27242-00532-6 Food City Oaxaca 16 oz. Tio Francisco, San Carlos Available to consumers at retail deli counters in various sizes Tio Francisco Oaxaca
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0940-2024·2024-02-07

    Olympus EZDilate Endoscopic Dilation Balloons Recalled for Device Failures

    Olympus is recalling 2,991 EZDilate endoscopic balloons for problems with inflation and deflation. Reports include device bursting and leaking, and retained foreign bodies in patients during procedures.

    Product
    EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0933-2024·2024-02-07

    EZDilate esophageal balloons recalled for inflation failure and device leaking

    Olympus is recalling EZDilate Fixed Wire Balloons for inflation and deflation failures. The devices may burst, leak, or leave foreign material in patients.

    Product
    EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0941-2024·2024-02-07

    Endoscopic Dilation Balloons Recalled for Bursting and Leaking Failures

    Olympus recalled 3,354 EZDilate wire-guided dilation balloons due to failures in inflation, deflation, and retrieval, with incidents of bursting, leaking, and foreign bodies left in patients.

    Product
    EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0817-2024·2024-02-07

    Melissa's Hot Kimchi Pickled Napa Cabbage Recalled for Undeclared Fish Allergen

    Melissa's Hot Kimchi Pickled Napa Cabbage is being recalled due to undeclared fish allergen. 124 cases were distributed to California, Texas, and Florida.

    Product
    Melissa's Hot Kimchi Pickled Napa Cabbage NET WT. 14 oz (397g) Ingredients: Napa Cabbage, Radish, Water, Garlic, Red Pepper, Organic Sugar Cane, Sea Salt, Calcium Lactate, Ginger, Onion, Sorbitol, and Xanthan Gum. Produce on equipment that also processes products containing fi
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0278-2024·2024-02-07

    FentaNYL Citrate IV Bags Recalled Due to Double-Dose Filling System Malfunction

    FentaNYL citrate intravenous bags are recalled nationwide because a semi-automated filling system can malfunction and deliver double the intended dose. Patients and healthcare providers should immediately quarantine affected lots.

    Product
    FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0942-2024·2024-02-07

    EZDilate Wire Guided Balloon Recalled for Device Malfunction and Patient Injury Risk

    Olympus recalled 3,767 EZDilate Wire Guided Balloons due to reported inflation, deflation, and retrieval problems causing bursting, leaking, and foreign body lodgement in patients. The devices dilate strictures in the alimentary tract.

    Product
    EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1555
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0916-2024·2024-02-07

    FDA Recalls Cotija Cheese for Listeria Monocytogenes Contamination

    Rizo Lopez Foods recalls multiple brands of cotija cheese due to potential Listeria monocytogenes contamination. Products were distributed through retail deli counters across 20 U.S. states.

    Product
    Rizo Bros Cotija (Grated) 8 oz. UPC 72724200043 7 oz. UPC 7-27242-14022-5 Tio Francisco, Casa Cardenas 9 oz. UPC 7-27242-00022-2 & 8-11371-27109-4 Rizo Bros Cotija 8 oz. UPC 7-27242-00043-7 Tio Francisco Cotija 14 oz. 7-27242-00517-3 Food City Cotija 16 oz. Tio Francis
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0928-2024·2024-02-07

    Monterey Jack Cheese Recalled for Listeria Monocytogenes Contamination

    Bulk Monterey Jack cheese from Rizo Lopez Foods is being recalled due to Listeria monocytogenes contamination. The product was distributed to multiple U.S. states.

    Product
    Monterey Jack Conventional (bulk)
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0918-2024·2024-02-07

    Sour Cream Products Recalled for Listeria Monocytogenes Contamination

    Rizo Lopez Foods has recalled multiple sour cream and cream products due to Listeria monocytogenes contamination. Products were distributed across multiple U.S. states.

    Product
    Tio Francisco Crema Centroamericana 16 oz. UPC 7-27242-00440-4 Tio Francisco, Campesino Crema Centroamericana Available to consumers at retail deli counters in various sizes Tio Francisco Crema Latina 16 oz. UPC 7-27242-35445-5 Tio Francisco Crema Latina Available to consumer
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0805-2024·2024-02-07

    Multiple Tuna Products Recalled Due to Listeria Monocytogenes Contamination

    Ocean Group Inc. is recalling tuna products distributed in California due to potential Listeria monocytogenes contamination identified through FDA environmental sampling.

    Product
    201000 TUNA, HAWAII #1 USA W LB 201002 TUNA HAWAII #1 USA W LB 201200 TUNA FRESH, WILD Y/F,B/E #2 GRADE 201300 TUNA BLUEFIN SPAIN SPA F LB 201301 TUNA BLUEFIN SPAIN (SE) SPAIN F LB 201304 TUNA BLUEFIN SPAIN G&G SPAIN F LB 201508 TUNA BLUE FIN GG JAPAN FR JPN F LB 201900 TU
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0808-2024·2024-02-07

    Shennongyuan Dried Longan Recalled Due to Undeclared Sulfites

    J T Trading Inc. is recalling Shennongyuan Dried Longan due to undeclared sulfites. Consumers with sulfite sensitivities should not consume this product.

    Product
    Shennongyuan Dried Longan packaged in a silver metal box bulk 18kgs
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0281-2024·2024-02-07

    Vancomycin IV bags recalled due to filling system malfunction causing double doses

    Denver Solutions is recalling 10,152 Vancomycin IV bags nationwide because a filling system malfunction can deliver double doses of the antibiotic medication.

    Product
    VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0926-2024·2024-02-07

    Tio Francisco Yogurt recalled for potential Listeria monocytogenes contamination

    Tio Francisco Yogurt products in multiple flavors are being recalled due to potential Listeria monocytogenes contamination. Consumers who have purchased these yogurts should not consume them.

    Product
    Tio Francisco Yogurt (Plain, Strawberry, Peach, Mango) Available to consumers at retail deli counters in various sizes
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0804-2024·2024-02-07

    Salmon fillets recalled for potential Listeria monocytogenes contamination

    Ocean Group Inc. is recalling frozen salmon fillet products distributed in California due to potential Listeria monocytogenes contamination detected during FDA environmental sampling.

    Product
    202225 SALMON BAKKA FROST FILLET 6/7KG FR FRO F LB 202002 SALMON BAKKAFROST FAROE ISLANDS 5/6KG FR FRO F LB 202012 SALMON BAKKAFROST FAROE ISLANDS 6/7KG FR FRO F LB 202022 SALMON BAKKAFROST FAROE ISLANDS 7/8KG FR FRO F LB 202032 SALMON BAKKAFROST FAROE ISLANDS 8/9KG FR FRO F
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0924-2024·2024-02-07

    Rizo Lopez Tio Francisco Requeson Recalled for Listeria Contamination

    Tio Francisco Requeson cheese products are recalled due to Listeria monocytogenes contamination. Consumers should not consume affected products and should return them to the store.

    Product
    Tio Francisco Requeson 14 oz. UPC 7-27242-00390-6 Tio Francisco Requeson 15 oz. UPC 7-27242-00392-6 Tio Francisco Requeson Available to consumers at retail deli counters in various sizes
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0922-2024·2024-02-07

    Tio Francisco Queso Para Freir Recalled Due to Listeria Contamination

    Tio Francisco Queso Para Freir (frying cheese) is being recalled due to potential Listeria monocytogenes contamination. The recall affects multiple batches distributed across multiple U.S. states.

    Product
    Tio Francisco Queso Para Freir 16 oz. Tio Francisco Queso Para Freir Available to consumers at retail deli counters in various sizes Freir (bulk)
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0923-2024·2024-02-07

    Tio Francisco Queso Seco Cheese Recalled for Listeria Monocytogenes

    Rizo Lopez Foods is recalling Tio Francisco Queso Seco 14 oz. cheese due to Listeria monocytogenes contamination. The product was distributed across multiple U.S. states with production dates through July 31, 2024.

    Product
    Tio Francisco Queso Seco 14 oz. UPC 7-27242-00548-8
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0925-2024·2024-02-07

    Ricotta cheese products recalled for Listeria monocytogenes contamination

    Multiple ricotta cheese products from Rizo Lopez Foods are recalled nationwide due to potential Listeria monocytogenes contamination. Affected batches have best-by dates through April 2, 2024.

    Product
    365 Whole Foods Market Ricotta Part Skim 15 oz. UPC 9-94824-63052 365 Whole Foods Market Ricotta Whole Milk 15 oz. UPC 9-94824-96245 Ricotta Part Skim 65%, 70%, 75% Moisture (bulk)
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0919-2024·2024-02-07

    Queso Fresco from Multiple Brands Recalled for Listeria Contamination

    Rizo Lopez Foods, Inc. is recalling various queso fresco products from multiple brands due to potential Listeria monocytogenes contamination. The affected products were distributed to retail locations in multiple U.S. states.

    Product
    Tio Francisco, El Huache, La Ordena Fresco (Michoacano) Available to consumers at retail deli counters in various sizes Tio Francisco, San Carlos Available to consumers at retail deli counters in various sizes Rizo Bros. Queso 8 oz. UPC 7-27242-00159-5 Don Francisco 10 oz. UP
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0917-2024·2024-02-07

    Cheese product recalled for Listeria monocytogenes contamination

    Rizo Lopez Foods is recalling Tio Francisco Blanco Suave cheese due to potential Listeria monocytogenes contamination. Affected products have date codes through March 23, 2024.

    Product
    Tio Francisco Blanco Suave 14 oz. UPC 7-27242-05355-6
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0921-2024·2024-02-07

    Panela Cheese Products Recalled for Listeria Monocytogenes Contamination

    Rizo Lopez Foods is recalling Tio Francisco and related panela cheese products due to potential Listeria monocytogenes contamination. Affected products were distributed across multiple states.

    Product
    Tio Francisco Panela 14 oz. UPC 7-27242-00550-0 Food City Panela 16 oz. Tio Francisco, San Carlos, Dos Ranchitos, La Ordena, Campesino Panela Available to consumers at retail deli counters in various sizes Tio Francisco Panela Barra Available to consumers at retail deli counte
    Category
    Food
    Distribution
    20 states
  • SevereNHTSA·24V081000·2024-02-07

    Suzuki Recalls 2024 GSX-8R Motorcycles for Drive Chain Defect

    Suzuki is recalling 2024 GSX-8R motorcycles because the drive chain may detach due to missing rivets, which can cause a loss of power to the rear wheels and increase crash risk.

    Product
    SUZUKI — SUZUKI GSX-8R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2024·2024-02-07

    Knee implant component recalled due to potential material oxidation

    Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee implant components made from UHMWPE material over 5 years old that may develop elevated oxidation.

    Product
    SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V078000·2024-02-07

    Blue Bird Recalls School Buses Due to Improperly Installed Convertible Seats

    Blue Bird is recalling 2020-2024 Vision and All American school buses because convertible seats may be incorrectly installed, creating a risk of injury during a crash.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0836-2024·2024-02-07

    Medical sterilization chemical integrators recalled due to labeling discrepancy

    TERRAGENE S.A. is recalling over 36,000 chemical integrator strips used to verify sterilization in healthcare settings because the instructions distributed with the products don't match the FDA-cleared instructions for use.

    Product
    Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V079000·2024-02-07

    Blue Bird Recalls Transit Buses Due to Incorrectly Installed Seats

    Blue Bird is recalling 2021-2023 Vision and All American transit buses because convertible seats may be incorrectly installed, posing a crash injury risk.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN TRANSIT BUS, VISION TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0955-2024·2024-02-07

    Philips MRI Coil Seal Adhesive May Fail and Create Sharp Patient Contact Surfaces

    Philips has recalled certain SmartPath to dStream MRI coil components because the seal adhesive may fail, creating sharp edges that could contact patients during scanning and cause skin and tissue injuries.

    Product
    SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2024.