The Recall Desk

Archive

May 2024 recalls

616 recalls were announced in May 2024.

What the numbers show

Critical
13
Severe
129
High
400
Moderate
72
Low
2

Of the 616 recalls this month scored against our rubric, 2% are Critical, 21% are Severe.

301–400 of 616

  • HighFDA (Food)·F-1242-2024·2024-05-22

    Canned Jalapenos Recalled Due to Glass Contamination Hazard

    M-C McLANE INTERNATIONAL is recalling canned jalapenos due to potential glass contamination. The voluntary recall affects 2991 cases distributed across 27 states.

    Product
    Jalapenos packed in 6lb 10oz cans. 6 cans per case
    Category
    Food
    Distribution
    28 states
  • HighFDA (Devices)·Z-1828-2024·2024-05-22

    CoFlex NL Sterile Bandages Recalled for Packaging Seal Gaps

    Andover Healthcare Inc. is recalling CoFlex NL sterile flexible cohesive bandages (model 5400S) due to packaging seal gaps that could compromise product sterility. No illnesses have been reported.

    Product
    Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1802-2024·2024-05-22

    Medtronic Disposable Pressure Display Sets recalled for unsealed sterile packaging

    Medtronic Perfusion Systems recalls 1,624 Disposable Pressure Display Sets (Models 61000 and 62000) distributed worldwide due to potential for unsealed sterile packing. No illnesses or injuries have been reported.

    Product
    Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1805-2024·2024-05-22

    Medtronic Venous Cannulae Recalled for Unsealed Sterile Packaging

    Medtronic Perfusion Systems is recalling 17,221 units of venous cannulae due to potential for unsealed sterile packaging. The devices were distributed worldwide to healthcare facilities.

    Product
    Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP¿ 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP¿ 30 Fr. Malleab
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1237-2024·2024-05-22

    Organic Yogi Echinacea Immune Support Tea Recalled for Pesticide Residues

    East West Tea Company is recalling Organic Yogi Echinacea Immune Support tea bags nationwide due to pesticide residues detected above FDA action levels.

    Product
    Organic Yogi Echinacea Immune Support, Caffeine Herbal Supplement, Serving Size 1 tea bag, 16 tea bags per pack, 4 packs per box. UPC on box: 0 76950 45010 3. CASE GTIN: 60076950450105. East West Tea Company, LLC Eugene, OR Yogi Echinacea Immune Support, Caffeine Herbal Suppleme
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1793-2024·2024-05-22

    Medtronic Arterial Cannulae Recalled Due to Unsealed Sterile Packaging

    Medtronic Perfusion Systems is recalling multiple arterial cannula models worldwide due to potential for unsealed sterile packing. Compromised packaging may allow contamination of devices intended for clinical use.

    Product
    Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220; c) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 82020; d) DLP¿ Curved Metal
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1818-2024·2024-05-22

    Free T3 Reagent Pack May Produce Inaccurate Test Results

    QUIDELORTHO's VITROS Free T3 Reagent Packs may produce falsely elevated test results, potentially affecting thyroid function diagnoses and patient management. Eight lot numbers with expiry dates through August 2024 were distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0495-2024·2024-05-22

    Gordofilm Wart Remover Recalled Due to Manufacturing Deviations

    Gordofilm Wart Remover by Gordon Laboratories is being recalled nationwide due to Current Good Manufacturing Practice (cGMP) deviations. The FDA classified this as a Class II recall on May 13, 2024.

    Product
    Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0500-2024·2024-05-22

    Magnesium Citrate Laxative Recalled for Bacterial Contamination

    CVS Health Magnesium Citrate Saline Laxative Oral Solution is being recalled nationwide due to microbial contamination with Acetobacter nitrogenifigens bacteria in lot A81506.

    Product
    MAGNESIUM CITRATE — MAGNESIUM CITRATE (CVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0501-2024·2024-05-22

    OTC Magnesium Citrate laxative recalled for microbial contamination

    Meijer Magnesium Citrate Saline Laxative is being recalled due to microbial contamination. Lot A81834 (expiration 1/31/2026) was distributed nationwide; consumers should stop using the product.

    Product
    MAGNESIUM CITRATE — MAGNESIUM CITRATE (MAGNESIUM CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1241-2024·2024-05-22

    Multiple Brands Whole Milk Recalled for Potential Potable Water Content

    Multiple brands of Hiland and store-brand whole milk sold in Kansas and Missouri are being recalled because they may contain potable water, which is a composition concern.

    Product
    1. Country Club, Price Chopper, Good & Gather, Hiland, Belfonte, Great Value, Hen House Vitamin D Whole Milk, 1 gallon. 2. Country Club, Price Chopper, Good & Gather, Best Choice, Good Nature Family Farms Vitamin D Whole Milk, Half Gallon. 3. Belfonte, Hiland Vitamin D Whole Milk
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·24E038000·2024-05-21

    Cummins Recalls L9 Diesel Engines Due to Fuel Hose Separation Risk

    Cummins is recalling L9 diesel engines because remote fuel filter hoses may separate, causing fuel leaks, fire risks, or engine stalls.

    Product
    FUEL SYSTEM, DIESEL:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V356000·2024-05-21

    Turtle Top Recalls 2024 Vehicles Due to Seat Recliner Defect

    Turtle Top is recalling 2024 Van Terra, Terra Transit, Odyssey, and Odyssey XL vehicles because the seat recliner mechanism may not engage, increasing injury risk in a crash.

    Product
    TURTLE TOP — TURTLE TOP TERRA TRANSIT, ODYSSEY, VAN TERRA, ODYSSEY XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V358000·2024-05-21

    Kia Recalls 2022 Niro EV Vehicles Due to Battery Fire Risk

    Kia is recalling 2022 Niro EV vehicles because a high-voltage battery safety plug may overheat and melt, potentially causing a fire or loss of drive power.

    Product
    KIA — KIA NIRO EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V357000·2024-05-21

    Vermeer Recalls BC900XL Trailers Due to Incorrect Manual Torque Values

    Vermeer is recalling 2015-2022 BC900XL brush chipper trailers because the service manuals list incorrect lug nut torque values, which could lead to wheel detachment.

    Product
    VERMEER — VERMEER BC900XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V355000·2024-05-21

    Prime-Time Ford Transit Conversion Recall for Seat Recliner Defect

    Prime-Time is recalling 2023-2024 Ford Transit conversions because the seat recliner mechanism may not engage, increasing injury risk in a crash.

    Product
    PRIME-TIME — PRIME-TIME FORD TRANSIT CONVERSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V354000·2024-05-20

    ATC Recalls 2021-2024 Toy Hauler Trailers Due to Fire Risk

    ATC is recalling 2021-2024 Toy Hauler trailers because a faulty LED circuit board in the cooktop may overheat and cause a fire.

    Product
    ATC — ATC TOYHAULER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V353000·2024-05-20

    FR Conversions Recalls 2023-2024 Ram Promaster Vehicles for Seat Defect

    FR Conversions is recalling 2023-2024 Ram Promaster vehicles because the seat recliner mechanism may not engage, increasing injury risk during a crash.

    Product
    FR CONVERSIONS — FR CONVERSIONS RAM PROMASTER CONVERSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V352000·2024-05-17

    Braunability Recalls 2023-2024 Chrysler Wheelchair Vans for Seat Defect

    Braunability is recalling 2023-2024 Chrysler Voyager wheelchair vans because the seat recliner mechanism may not engage, increasing injury risk in a crash.

    Product
    BRAUNABILITY — BRAUNABILITY CHRYSLER WHEELCHAIR VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V351000·2024-05-17

    2023–2025 Forest River Motorhomes Recalled for Unsecured LP Line

    Forest River is recalling certain 2023–2025 Solera, Forester, and Sunseeker motorhomes because the Liquid Propane line may not be properly secured, creating a fire risk if the line becomes damaged and leaks.

    Product
    FOREST RIVER — FOREST RIVER SUNSEEKER, SOLERA, FORESTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24235·2024-05-16

    Electrolux Frigidaire and Kenmore Electric Ranges Recalled for Fire and Burn Hazards

    Electrolux is recalling about 203,000 Frigidaire and Kenmore smooth-top electric ranges because heating elements can turn on unexpectedly, fail to turn off, or heat incorrectly, posing fire and burn risks. At least 212 incidents have been reported since 2009, including 14 fires and 8 burn injuries.

    Product
    Frigidaire and Kenmore Smooth-top Freestanding Electric Ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24237·2024-05-16

    Kano Laboratories Recalls Super Lube Products for Non-Child-Resistant Packaging

    Kano Laboratories is recalling Super Lube Syncopen Synthetic Penetrant, Fire Resistant Hydraulic Fluid, and Metal Protectant and Corrosion Inhibitor products in sizes of five gallons or less because the packaging is not child-resistant as required by law, posing a poisoning risk to young children.

    Product
    Super Lube Syncopen Synthetic Penetrant, Super Lube Fire Resistant Hydraulic Fluid, and Super Lube Metal Protectant and Corrosion Inhibitor (consumer sizes of five gallons or less)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24236·2024-05-16

    CHZHVAN Combination Smoke and Carbon Monoxide Detectors Recalled for Failure to Alert

    CHZHVAN combination smoke and carbon monoxide detectors can fail to activate and may not alert users to a fire. About 6,800 units sold online via Amazon.com from August 2023 through January 2024 are affected.

    Product
    CHZHVAN Combination Smoke and Carbon Monoxide Detectors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V346000·2024-05-16

    2024 Jeep Grand Cherokee: Missing Bumper Foam May Prevent Airbag Deployment

    Certain 2024 Jeep Grand Cherokees may be missing foam in the front bumper, which could prevent the front airbags from deploying during a crash. Dealers will install the foam at no cost.

    Product
    JEEP — JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V347000·2024-05-16

    Custom Truck Recalls 2020 Ford F-550 for Electrical Fire Risk

    Custom Truck is recalling one 2020 Ford F-550 because a wiring fault may cause electrical circuits to overheat and increase fire risk.

    Product
    CUSTOM TRUCK & BODY WORKS — CUSTOM TRUCK & BODY WORKS FORD F-550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V349000·2024-05-16

    Mazda Recalls 2024 CX-90 Vehicles for Automatic Braking Defect

    Mazda is recalling 2024 CX-90 vehicles because the automatic emergency braking system may falsely detect objects, causing sudden braking and increasing crash risk.

    Product
    MAZDA — MAZDA CX-90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V348000·2024-05-16

    2024 Lamborghini Urus Hood Latch May Separate While Driving

    Lamborghini is recalling 2023-2024 Urus Performante and Urus S vehicles because the hood latch striker may separate, causing the hood to open or detach while driving and create a road hazard.

    Product
    LAMBORGHINI — LAMBORGHINI URUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1231-2024·2024-05-15

    Chocolate Ice Cream Cookie Sandwiches Recalled for Undeclared Allergens

    Belgian Yummies recalls Chocolate Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens: milk, eggs, wheat, peanuts, and tree nuts. Consumers with allergies should not consume this product.

    Product
    Chocolate Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·24V343000·2024-05-15

    Porsche Recalls 2024 718 Models Due to Shift Cable Installation Issue

    Porsche is recalling 2024 718 Cayman and Boxster vehicles because a safety clip may not be installed properly, potentially preventing the transmission from locking in park.

    Product
    PORSCHE — PORSCHE 718 CAYMAN, 718 BOXSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1235-2024·2024-05-15

    Peanut Butter Ice Cream Cookie Sandwich Recalled: Undeclared Allergens

    Belgian Yummies is recalling Peanut Butter Ice Cream Cookie Sandwiches distributed in Florida due to undeclared milk, eggs, wheat, peanuts, and tree nuts. Consumers with allergies should not consume the product.

    Product
    Peanut Butter Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1609-2024·2024-05-15

    Insulin pump app may crash and drain battery, risking insulin delivery interruption

    Tandem's t:connect app version 2.7+ may crash repeatedly, draining the insulin pump battery faster than expected and potentially interrupting insulin delivery.

    Product
    t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V341000·2024-05-15

    Navistar Recalls 2024-2025 IC Bus School Buses for Brake Defect

    Navistar is recalling 2024-2025 IC Bus school buses because a faulty valve module may cause park brake failure or unexpected engagement.

    Product
    IC BUS — IC BUS CE SBUS, CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1230-2024·2024-05-15

    Vanilla Ice Cream Cookie Sandwiches Recalled for Undeclared Allergens

    Belgian Yummies is recalling Vanilla Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens: milk, eggs, wheat, peanuts, and tree nuts.

    Product
    Vanilla Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1236-2024·2024-05-15

    Belgian Yummies ice cream recalled for undeclared milk and wheat

    Belgian Yummies Homemade Ice Cream Horchata Gelato distributed in Florida is recalled due to undeclared milk and wheat allergens that may affect consumers with allergies.

    Product
    Belgian Yummies Homemade Ice Cream Horchata Gelato. Packaged in 4.75 Liter gray pan.
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·24V342000·2024-05-15

    Morbark Brush Chippers Recalled for Fuel Line Fire Risk

    Alamo Group is recalling 2023-2024 Morbark brush chippers because fuel lines may lack the required pressure rating, creating a fire hazard.

    Product
    MORBARK — MORBARK EEGER BEEVER 1922, EEGER BEEVER 2131, EEGER BEEVER 1821
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1234-2024·2024-05-15

    Key Lime Ice Cream Cookie Sandwiches Recalled for Undeclared Allergens

    Belgian Yummies is recalling Key Lime Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens: milk, eggs, soy, wheat, peanuts, and tree nuts. Consumers with these allergies should not consume the product.

    Product
    Key Lime Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1224-2024·2024-05-15

    D-LO's Pistachio Cheesecake Recalled for Undeclared Allergens and Food Coloring

    D-LO's Delightful Gourmet Cheesecake in pistachio flavor is being recalled due to undeclared wheat and soy allergens and undeclared food colors. The product poses a health risk to consumers with allergies to these ingredients.

    Product
    D-LO's Delightful Gourmet Cheesecake, Pistachio, 142g single serve UPC 8 60007 40398 9, and 678g six serving UPC 8 60007 40395 8, both serving sizes in clear plastic container with hinged lid
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1776-2024·2024-05-15

    Stealth S8 neurosurgical navigation software display error affecting surgical guidance

    Medtronic's Stealth S8 surgical navigation software has a display bug that may omit digits, letters, or decimals from critical readings during brain surgery. FDA classified this as Class I due to serious potential surgical errors.

    Product
    Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0486-2024·2024-05-15

    Sapropterin Dihydrochloride Powder for Oral Solution Recalled Due to Sub-Potency

    Dr. Reddy's Laboratories is recalling 2,402 cartons of Sapropterin Dihydrochloride Powder 100mg due to sub-potency associated with powder discoloration. The affected lot (T2200352) was distributed nationwide.

    Product
    Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1730-2024·2024-05-15

    Vyaire Twin Tube Sample Line Nozzle Separation Recall

    Vyaire Medical recalls Twin Tube sample line 240 cm devices (Model V-707327) due to potential nozzle separation during patient use. All lots manufactured prior to June 2023 are potentially affected.

    Product
    Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0485-2024·2024-05-15

    Prescription Drug Javygtor Recalled for Sub-Potency and Powder Discoloration

    Dr. Reddy's Laboratories is recalling Javygtor powder packets nationwide due to powder discoloration and sub-potency. The recall affects 17,332 cartons with multiple lot numbers.

    Product
    JAVYGTOR — JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1233-2024·2024-05-15

    Belgian Yummies Salted Caramel Ice Cream Cookie Sandwiches recalled for undeclared allergens

    Belgian Yummies is recalling Salted Caramel Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens including milk, eggs, soy, wheat, peanuts, and tree nuts. The recall affects 254 units.

    Product
    Salted Caramel Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1733-2024·2024-05-15

    Hologic BioZorb Bioabsorbable Markers Recalled for Adverse Events

    Hologic is recalling BioZorb Marker bioabsorbable surgical markers due to reported adverse events including infection, pain, device migration, and erosion. FDA classified this as Class I, affecting 53,492 units nationwide.

    Product
    BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Mark
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V345000·2024-05-15

    BMW 2024-2025 X5, X6, X7, XM, and Alpina XB7 Seat Belt Detection System Defect

    BMW recalls certain 2024-2025 X5, X6, X7, XM, and Alpina XB7 models due to a seat belt detection system defect that may fail to alert drivers of unbuckled passengers or allow proper deployment of the supplemental restraint system.

    Product
    BMW — BMW ALPINA XB7, X6, XM, X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1232-2024·2024-05-15

    Raspberry Ice Cream Cookie Sandwich Recalled for Undeclared Allergens

    Belgian Yummies is recalling Raspberry Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens including milk, eggs, wheat, peanuts, and tree nuts. Consumers with allergies should not consume these products.

    Product
    Raspberry Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1763-2024·2024-05-15

    Duraflow 2 vascular catheter kit recalled for loose metal shavings

    Angiodynamics Inc. is recalling DURAFLOW 2 vascular catheter kits used for hemodialysis and apheresis access due to potential metal shavings that may detach and travel through the vascular system, potentially requiring surgical removal.

    Product
    DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1758-2024·2024-05-15

    Spinal Fusion Device Recall: Setscrew Insertion and Tightening Issues

    SPINEART's PERLA TL 25D spinal fusion screws are being recalled due to difficulties with setscrew insertion inside the screw head. The setscrew may not be properly tightened or may be positioned incorrectly, potentially affecting spinal stability.

    Product
    PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S The PERLA¿ TL system is intended to provide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V339000·2024-05-15

    Multiple travel trailers recalled for detaching freshwater tanks

    Forest River travel trailers may have freshwater tanks that detach when full, posing a road hazard. Dealers will install additional attachment straps at no cost.

    Product
    CLIPPER TOWABLE — CLIPPER TOWABLE, VIKING TOWABLE, INDEPENDENCE TRAIL TRAILE CWT182DBU, VWT182DBU, VWT262BHS, VWT26SBHSAGA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1780-2024·2024-05-15

    GE Healthcare Allia IGS 7 X-ray Systems Adhesive Bolt Failure Recall

    GE Healthcare is recalling Allia IGS 7 interventional x-ray systems due to potential adhesive failure on bolts securing the detector and x-ray tube, which could fall during use.

    Product
    GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V344000·2024-05-15

    2021-2023 Volkswagen ID.4 display software defect increases crash risk

    Certain 2021-2023 Volkswagen ID.4 vehicles experience a software issue causing display failures that hide the speedometer and rearview camera. Dealers will update the software at no cost.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1219-2024·2024-05-15

    FDA Recalls Sacramento Cookie Factory Wine Wafers for Undeclared Milk Allergen

    Sacramento Cookie Factory recalls Original Wine Wafer - Lemon Vanilla cookies in multiple states due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    Original Wine Wafer - Lemon Vanilla [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·F-1220-2024·2024-05-15

    Martinelli's Gold Medal Apple Juice Recalled for Elevated Inorganic Arsenic

    S Martinelli & Company is recalling Martinelli's Gold Medal Apple Juice (1 Liter) due to elevated levels of inorganic arsenic. The affected product has Best By dates of March 9, 2026 or March 10, 2026.

    Product
    Martinelli's Gold Medal Apple Juice From U.S. Grown Fresh Apples 1 Liter (33.8 fl oz.) No Additives of Any Kind UPC 0 00 41244 00102 6
    Category
    Food
    Distribution
    35 states
  • HighFDA (Drugs)·D-0483-2024·2024-05-15

    Duloxetine delayed-release capsules recalled for manufacturing impurity exceeding limits

    Breckenridge Pharmaceutical recalls Duloxetine 20 mg capsules nationwide after detecting N-nitroso-duloxetine impurity above FDA-recommended limits in approximately 7,188 units from lot 220456, expiring February 2025.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·24V340000·2024-05-15

    2025 MINI Countryman Rear Armrest May Detach During Airbag Deployment

    BMW is recalling 9 2025 MINI Countryman vehicles because the armrest support bracket on the rear side door panel may be improperly secured and detach during an airbag deployment, potentially striking occupants or interfering with airbag function.

    Product
    MINI — MINI COUNTRYMAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1228-2024·2024-05-15

    Ice Cream Strawberry Gelato Recalled for Undeclared Yellow #5 Allergen

    Belgian Yummies is recalling 53 units of 5-liter strawberry gelato distributed in Florida due to undeclared Yellow #5 (Tartrazine) allergen. Consumers with Yellow #5 sensitivity should not consume this product.

    Product
    Belgian Yummies Homemade Ice Cream Strawberry Gelato. Packaged in 5 Liter gray carapina liner.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1227-2024·2024-05-15

    DB Yummers Island Marinade BBQ Sauce Recalled for Unapproved Processing

    Detty Family Barbeque LTD is recalling DB Yummers Island Marinade Barbeque Sauce because it was not manufactured using an FDA-approved thermal processing procedure, creating potential for pathogenic contamination.

    Product
    DB Yummers Island Marinade Barbeque Sauce packaged in 19.5 glass bottles, 12 bottles per case, UPC 7487200103.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1762-2024·2024-05-15

    Hemodialysis Vascular Access Kit Recalled for Loose Metal Shavings

    Angiodynamics DURAFLOW 2 hemodialysis kits may contain loosely affixed metal shavings that could enter the bloodstream. Metal fragments may require surgical removal if they embolize.

    Product
    DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012035
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0493-2024·2024-05-15

    Prescription antifungal injection product recalled for out-of-specification assay

    Sun Pharmaceutical is recalling Amphotericin B for Injection (50 mg vials) due to out-of-specification assay results. The recall affects 11,016 vials with lot numbers BAE0055A, BAE0056A, and BAE0068A distributed nationwide.

    Product
    AMPHOTERICIN B — AMPHOTERICIN B (AMPHOTERICIN B)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1781-2024·2024-05-15

    GE Allia IGS Fluoroscopic X-Ray Systems Adhesive Bolt Defect

    GE Healthcare recalled certain Allia IGS and related fluoroscopic x-ray systems due to potential incomplete adhesive on bolts in the gantry assembly, risking detector or tube failure.

    Product
    GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1769-2024·2024-05-15

    Angiodynamics Duramax Vascular Access Kit Recall Due to Metal Shavings

    Angiodynamics recalls the Duramax Stacked Tip vascular access kit used for hemodialysis due to potential loose metal shavings that could enter the bloodstream and require surgical removal.

    Product
    DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028045
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1757-2024·2024-05-15

    Philips 5000 Compact Series Ultrasound Systems pose uncontrolled burn risk

    Philips 5000 Compact Series ultrasound systems may leave unselected transesophageal transducers powered without temperature monitoring, risking patient burns during imaging procedures.

    Product
    5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come with multiport adapters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1760-2024·2024-05-15

    Hemodialysis vascular access kit recalled for loose metal shavings

    Angiodynamics recalls 455 DURAFLOW 2 hemodialysis kits for loose metal shavings that could embolize, potentially requiring surgical removal.

    Product
    DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012015
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1761-2024·2024-05-15

    Vascular access device recalled due to loose metal shavings

    DURAFLOW 2 vascular access kits for hemodialysis are being recalled because some units may contain loosely affixed metal shavings that could travel through blood vessels and potentially require surgical removal.

    Product
    DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1772-2024·2024-05-15

    Angiodynamics vascular access catheter subject to voluntary recall

    Angiodynamics has voluntarily recalled 285 units of DURAMAX STACKED TIP vascular access catheters (lots 5807195 and 5807196) used for hemodialysis. The specific reason for the recall is not disclosed in the FDA notice.

    Product
    DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028195
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1768-2024·2024-05-15

    Hemodialysis vascular access kit recalled due to metal shavings risk

    DURAMAX hemodialysis vascular access kits are recalled due to potential metal shavings that could enter the bloodstream and require surgical removal. Thirty units distributed in Virginia are affected.

    Product
    DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1766-2024·2024-05-15

    Medical Device Recall: Angiodynamics DURAMAX Tunneler with Metal Shavings

    Angiodynamics is recalling DURAMAX STACKED TIP medical devices that may contain loosely affixed metal shavings with potential to embolize, requiring possible surgical removal. The recall affects 50 units distributed in Virginia.

    Product
    DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1784-2024·2024-05-15

    X-ray C-arm Tabletop Recalled for Risk of Uncontrolled Motion

    NRT X-RAY A/S recalls Intelli-C X-ray tabletops due to faulty firmware and worn motor components that may cause uncontrolled C-arm motion, potentially striking patients or operators.

    Product
    Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2024·2024-05-15

    GE Healthcare X-Ray Systems Recalled for Loose Bolts on Gantry Assembly

    GE Healthcare is recalling x-ray imaging systems because adhesive on critical bolts may not have been applied, potentially causing the detector or x-ray tube to fall. The recall affects 21 units worldwide.

    Product
    GE Healthcare Innova IGS 5, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2024·2024-05-15

    DURAFLOW 2 Vascular Access Device Recalled for Loose Metal Shavings

    Angiodynamics is recalling DURAFLOW 2 vascular access devices due to loose metal shavings that may travel through blood vessels, potentially requiring surgical removal.

    Product
    DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012185
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0484-2024·2024-05-15

    Prescription Duloxetine 60 mg capsules recalled for N-nitroso impurity

    Breckenridge Pharmaceutical is recalling Duloxetine 60 mg capsules due to elevated levels of N-nitroso-duloxetine, a manufacturing impurity above FDA limits. No illnesses have been reported.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1770-2024·2024-05-15

    Vascular access device recalled for potential metal shavings embolism risk

    Angiodynamics recalls DURAMAX STACKED TIP vascular access devices that may contain loosely affixed metal shavings. Metal shavings could embolize and potentially require surgical removal.

    Product
    DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028055
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1225-2024·2024-05-15

    DB Yummers Barbecue Sauce Recalled Due to Improper Thermal Processing

    DB Yummers Sweet & Smokey Barbecue Sauce is recalled for lacking FDA-approved heat treatment. Bottles with best-by dates 05/18/25, 05/26/25, or 08/30/25 distributed in Kentucky and Ohio should not be consumed.

    Product
    DB Yummers Sweet & Smokey Barbeque Sauce packaged in 19.5 glass bottles, 12 bottles per case, UPC 74872001101.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1782-2024·2024-05-15

    GE Healthcare X-ray Systems: Potential Adhesive Failure Poses Fall Hazard

    GE Healthcare is recalling certain Allia and Discovery IGS x-ray systems due to potential adhesive failure that could cause the detector, elevator, or x-ray tube to fall. No injuries reported.

    Product
    GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1226-2024·2024-05-15

    DB Yummers Barbeque Sauce Recalled for Unapproved Processing Procedure

    Detty Family Barbeque LTD is recalling DB Yummers Mildly Spicy Barbeque Sauce because it was manufactured without FDA-approved processing procedures. About 7,080 bottles were distributed in Kentucky and Ohio.

    Product
    DB Yummers Mildly Spicy Barbeque Sauce packaged in 19.5 glass bottles, 12 bottles per case, UPC 7487200102.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1217-2024·2024-05-15

    Champagne Wafers with Undeclared Milk Allergen Recalled

    Sacramento Cookie Factory is recalling Champagne Wafer - Raspberry Almond cookies due to undeclared milk allergen. Products were distributed across 14 U.S. states and pose a serious risk to consumers with milk allergies.

    Product
    Champagne Wafer - Raspberry Almond [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-1773-2024·2024-05-15

    Vascular catheter recalled for potential metal shavings that may cause embolization

    Angiodynamics recalled a vascular access catheter used for hemodialysis because it may contain loosely affixed metal shavings. These shavings could potentially detach and move through blood vessels, possibly requiring surgical removal.

    Product
    DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028201
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1218-2024·2024-05-15

    Sacramento Cookie Factory Recalls Wine Wafers for Undeclared Milk Allergen

    Sacramento Cookie Factory is recalling California Wine Wafer - Mocha Chocolate products because they contain undeclared milk, a common allergen. The recall affects retail packages distributed across multiple U.S. states.

    Product
    California Wine Wafer - Mocha Chocolate and Original Wine Wafer - Mocha Chocolate [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·F-1215-2024·2024-05-15

    Java Wafer Cookies Recalled for Undeclared Milk Allergen

    Sacramento Cookie Factory is recalling Java Wafer - Mocha Hazelnut cookies because they contain undeclared milk, a common allergen that poses a health risk to people with milk allergies.

    Product
    Java Wafer - Mocha Hazelnut [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·F-1223-2024·2024-05-15

    Goya Red Kidney Beans Recalled for Swollen and Leaking Cans

    Tradewind Foods de Puerto Rico Inc. is recalling Goya Red Kidney Beans due to swollen and leaking cans discovered during an FDA inspection. The affected product was distributed in Puerto Rico and St. Croix.

    Product
    Goya Red Kidney Beans, Net Wt.15.5oz.(439g), metal (tin) cans, 24 cans/15.5 oz. per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1229-2024·2024-05-15

    Belgian Yummies Ice Cream Gelato Recalled for Undeclared Yellow #5 Allergen

    Belgian Yummies Homemade Ice Cream Birthday Cake Gelato is being recalled because it contains undeclared Yellow #5, an allergen not listed on the label. The recall affects products distributed in Florida.

    Product
    Belgian Yummies Homemade Ice Cream Birthday Cake Gelato. Packaged in 5 Liter gray carapina liner.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1216-2024·2024-05-15

    Tea Wafers with Vanilla Almond Recalled for Undeclared Milk

    Sacramento Cookie Factory recalled Tea Wafers with Vanilla Almond flavor due to undeclared milk allergen. The product was distributed to multiple states and may pose a risk to consumers with milk allergies.

    Product
    Tea Wafer - Vanilla Almond [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]
    Category
    Food
    Distribution
    14 states
  • HighFDA (Drugs)·D-0488-2024·2024-05-15

    Timolol Maleate ophthalmic solution recalled for defective container cap nozzle

    FDC Limited is recalling Timolol Maleate Ophthalmic Solution 0.5% distributed in New Jersey due to defective bottle caps with yellow spikes that can lodge in the nozzle, posing a risk of eye injury.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0489-2024·2024-05-15

    TraMADol HCl 50 mg Tablets Recalled for Foreign Baclofen Tablets

    RemedyRepack Inc. is recalling TraMADol HCl 50 mg tablets nationwide after a pharmacist discovered a baclofen tablet in a tramadol bottle. Taking the wrong medication poses serious health risks.

    Product
    TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0487-2024·2024-05-15

    Tramadol Hydrochloride Tablets Recalled Due to Baclofen Contamination

    Advagen Pharma is recalling Tramadol Hydrochloride Tablets after a pharmacy discovered baclofen tablets mixed in a bottle of tramadol. This nationwide recall affects 2,592 bottles.

    Product
    TRAMADOL HYDROCHLORIDE — TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0482-2024·2024-05-15

    Duloxetine prescription capsules recalled for N-nitroso impurity exceeding FDA limits

    Breckenridge Pharmaceutical recalls Duloxetine 30mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA-recommended interim limits. The impurity was identified as a CGMP manufacturing deviation.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1779-2024·2024-05-15

    Interact Discovery RT X-ray Systems Recalled for Component Fall Risk

    GE Healthcare is recalling certain x-ray systems because adhesive material may not be properly attached to bolts, which could cause components to fall during use.

    Product
    GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2024·2024-05-15

    Vascular access device recalls due to metal shaving contamination risk

    Angiodynamics is recalling the BioFlo DuraMax 15.5F Single Valve Sheath VascPak Kit due to possible loose metal shavings. Metal shavings could enter the bloodstream and require surgical removal.

    Product
    BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H965103038181
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1771-2024·2024-05-15

    DURAMAX vascular catheter recalled for possible metal shaving hazard

    The DURAMAX STACKED TIP vascular catheter may contain loosely affixed metal shavings that could embolize and require surgical removal. Lot 5807208 affected, 15 units.

    Product
    DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028191
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1765-2024·2024-05-15

    Vascular Access Catheter Recall Due to Metal Shaving Risk

    Angiodynamics is recalling 65 DURAFLOW 2 vascular access devices distributed in Virginia due to potential loose metal shavings that could enter the bloodstream and require surgical removal.

    Product
    DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1759-2024·2024-05-15

    Randox Clinical Chemistry Calibration Serum Recalled for Measurement Bias

    Randox Laboratories has recalled Clinical Chemistry Calibration Serum (Cal2351/Cal10388) due to negative bias in inorganic phosphate measurements on RX Series instruments. The issue could affect the accuracy of clinical chemistry test results.

    Product
    Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2024·2024-05-15

    GE Healthcare Allia IGS Fluoroscopic Systems Recall: Missing Adhesive

    GE Healthcare recalls Allia IGS and related interventional fluoroscopic x-ray systems due to potentially missing adhesive on bolts. The defect could allow the detector/elevator or x-ray tube in the gantry assembly to fall.

    Product
    GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2024·2024-05-15

    GE Innova IGS Fluoroscopic X-Ray Systems Adhesive Defect Recall

    GE Healthcare is recalling certain Innova IGS x-ray systems due to potential adhesive defects on component bolts. Missing adhesive could cause the detector or x-ray tube to fall during use.

    Product
    GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1775-2024·2024-05-15

    Baxter Spectrum IQ Infusion Pump recalled due to improper pre-release testing

    Baxter Healthcare is recalling one Spectrum IQ Infusion Pump that underwent improper testing before release. The device was distributed nationwide including in Massachusetts.

    Product
    Baxter Spectrum IQ Infusion Pump, Product Code 3570009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1767-2024·2024-05-15

    FDA Recalls Vascular Access Device Due to Loose Metal Shavings Risk

    Angiodynamics' DURAMAX STACKED TIP vascular access device may contain loosely affixed metal shavings that could cause blood vessel blockage, potentially requiring surgical removal.

    Product
    DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028035
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1786-2024·2024-05-15

    Evidence MultiSTAT analyzer foam gasket malfunction may affect test accuracy

    Randox Laboratories is recalling 40 units of the Evidence MultiSTAT analyzer because a foam gasket defect may allow light to leak into the camera during testing, potentially affecting result accuracy and delaying reporting.

    Product
    Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1785-2024·2024-05-15

    Stryker Dynamic Mesh Mislabeled with Incorrect Catalog Number

    Stryker shipped 63 units of cranial mesh labeled as catalog 56-90614 (Gold) but actually containing 56-90314 (Blue) mesh. The mislabeling may cause procedural delays.

    Product
    Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0492-2024·2024-05-15

    Clorazepate Dipotassium Tablets Recalled for Tablet Discoloration Defects Nationwide

    Aurobindo Pharma USA Inc. is recalling 6909 bottles of Clorazepate Dipotassium 7.5 mg tablets due to visible discoloration with yellow and dotted spots. No illnesses or injuries have been reported.

    Product
    CLORAZEPATE DIPOTASSIUM — CLORAZEPATE DIPOTASSIUM (CLORAZEPATE DIPOTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0490-2024·2024-05-15

    Prescription skin cleanser recalled nationwide due to subpotency

    Acella Pharmaceuticals recalled 7,104 bottles of Sodium Sulfacetamide 10% Sulfur 5% Cleanser nationwide because the product contained less active ingredient than labeled. The recall was terminated in December 2025.

    Product
    SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER — SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1222-2024·2024-05-15

    Dietary Supplement Labeling Error: Kirkman 5-MTHF Folic Acid Misdeclared

    Kirkman 5-MTHF dietary supplement has a labeling error: the Supplement Facts incorrectly states 5000mcg Folic Acid per serving instead of 1000mcg. Lot# 477-0016, exp. 08/2025.

    Product
    Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule dietary supplement, Folate 1667mcg DFE, 5000mcg Folic Acid, 120 capsules per package, UPC 8 12325 02354 7. Manufactured exclusively by: Kirkman, Lake Oswego, OR 9703,
    Category
    Drug
    Distribution
    7 states

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