The Recall Desk

Archive

July 2021 recalls

412 recalls were announced in July 2021.

What the numbers show

Critical
11
Severe
112
High
250
Moderate
36
Low
3

Of the 412 recalls this month scored against our rubric, 3% are Critical, 27% are Severe.

1–100 of 412

  • SevereNHTSA·21V594000·2021-07-30

    Kawasaki Recalls Ninja H2 SX Motorcycles Due to Rear Wheel Lockup Risk

    Kawasaki is recalling 2018-2021 Ninja H2 SX motorcycles because insufficient grease in the rear hub needle-bearing may cause failure, leading to rear wheel lock-up and increased crash risk.

    Product
    KAWASAKI — KAWASAKI NINJA H2 SX, ZX1002A, ZX1002D
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V593000·2021-07-30

    Kawasaki Recalls 2020-2021 Motorcycles Due to Engine Oil Valve Defect

    Kawasaki is recalling certain 2020-2021 motorcycles because an engine oil pressure relief valve may fail, causing a loss of oil pressure and potential engine stall.

    Product
    KAWASAKI — KAWASAKI Z H2, ZX1002L, NINJA H2, ZX1002N
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V592000·2021-07-30

    Ford Transit vehicles recalled for defective seat belt locking system

    Ford is recalling 2021-2022 Transit and 2021 Transit Connect vehicles because the front passenger seat belt locking retractor may deactivate, preventing child restraint securement. Unsecured child restraints increase crash injury risk.

    Product
    FORD — FORD TRANSIT CONNECT, TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V590000·2021-07-30

    Airstream Recalls 2022 Interstate 24X RVs Due to Inverter Wiring Fire Risk

    Airstream is recalling 2022 Interstate 24X recreational vehicles because improperly wired inverters may increase the risk of fire. Dealers will install additional wiring and circuit breakers free of charge.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V591000·2021-07-30

    Entegra Coach Motorhomes Recalled for Fuel Rail Sealing Defect

    Entegra Coach is recalling certain 2018-2022 Anthem, Aspire, Insignia, and Reatta XL motorhomes. A faulty sealing washer in the fuel rail assembly may leak, creating a fire risk. Contact Entegra Coach at 1-800-517-9137 for repairs.

    Product
    ENTEGRA — ENTEGRA REATTA XL, INSIGNIA, ASPIRE, ANTHEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V588000·2021-07-30

    Wabash National Van Trailers Recalled for Fuel Tank Bracket Defect

    Wabash National is recalling 2018-2022 Van Trailers because fuel tank brackets may detach, increasing the risk of a crash or injury.

    Product
    WABASH NATIONAL — WABASH NATIONAL VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·21173·2021-07-29

    Generac Portable Generators Recalled for Finger Amputation Hazard

    Generac is recalling about 321,160 portable generators (6500 and 8000 watt models) because an unlocked handle can pinch and amputate consumers' fingers when the generator is moved. Eight injuries have been reported, including seven finger amputations.

    Product
    Generac® and DR® 6500 Watt and 8000 Watt portable generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V586000·2021-07-29

    BMW Recalls 11,216 Vehicles for High-Pressure Fuel Pump Failure Risk

    BMW is recalling 11,216 vehicles from 2014-2018 because a high-pressure fuel pump failure could cause the engine to stall while driving, increasing the risk of a crash.

    Product
    BMW — BMW X3, 328D, 535D, X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V580000·2021-07-29

    Sutphen Fire Truck Recall: Fuel Rail Leak Risk

    Sutphen is recalling 2017-2020 Fire Trucks because a sealing washer may not seat correctly, causing the high-pressure fuel rail to leak and increasing fire risk.

    Product
    SUTPHEN — SUTPHEN FIRE TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V587000·2021-07-29

    Subaru and Toyota Recall Vehicles for Fuel Pump Failure Risk

    Subaru is recalling certain 2018-2020 models and Toyota 86 vehicles because a fuel pump may fail, causing engine stall and increasing crash risk.

    Product
    SUBARU — SUBARU, TOYOTA OUTBACK, WRX, FORESTER, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·026-2021·2021-07-29

    Greater Omaha Packing Recalls Raw Beef Products for E. Coli O157:H7

    Greater Omaha Packing is recalling approximately 295,236 pounds of raw beef products intended for non-intact use due to possible E. coli O157:H7 contamination.

    Product
    Greater Omaha Packing Co., Inc. — Greater Omaha Packing Recalls Raw Beef Products Due to Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·21V579000·2021-07-29

    Brake system calibration defect affects 2021 Chevrolet Tahoe and GMC Yukon

    General Motors is recalling certain 2021 Chevrolet Tahoe and GMC Yukon vehicles because dealer technicians may have incorrectly calibrated the brake system control module, potentially compromising braking performance and stability control.

    Product
    CHEVROLET — CHEVROLET, GMC TAHOE, YUKON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21770·2021-07-29

    Specialized Electric Mountain Bike Battery Packs Recalled for Fire and Burn Hazards

    Specialized is recalling about 2,500 first-generation Turbo Levo and Kenevo electric mountain bike battery packs because water can penetrate the seal around the LED control pad and cause the battery to short circuit, creating fire and burn hazards.

    Product
    Specialized 1st Generation Turbo Levo and Kenevo electric mountain bike battery packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V584000·2021-07-29

    Land Rover Defender Recall for Incorrect Child Seat Manual Information

    Jaguar Land Rover is recalling 2020-2021 Defender vehicles because the owner's manual incorrectly states that third-row seats have LATCH top tethers, which may lead to improper child seat installation.

    Product
    LAND ROVER — LAND ROVER DEFENDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21769·2021-07-29

    Children's Sleepwear Sets Recalled for Flammability Standard Violation

    SHEIN children's sleepwear sets fail to meet federal flammability standards and pose a burn injury risk. About 2,320 units sold online from August 2019 through January 2021 are affected.

    Product
    Children's Sleepwear Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V589000·2021-07-29

    Spartan RV Chassis Instrument Cluster May Intermittently Go Blank

    Shyft Group is recalling certain 2018-2022 Spartan RV Chassis models (K1, K2, K3, K4) because the instrument cluster may intermittently go blank while the vehicle is in motion, potentially obscuring critical speed and warning information.

    Product
    SPARTAN — SPARTAN K2, K4, K3, K1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V578000·2021-07-29

    2020-2021 Silverado 2500 and Sierra 2500 Spare Tire ABS Failure Recall

    General Motors is recalling 2020-2021 Silverado 2500 and Sierra 2500 trucks where a 17-inch spare tire paired with larger road tires prevents ABS from engaging, raising crash risk. Dealers will replace the spare tire and label at no cost.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 2500, SIERRA 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V585000·2021-07-29

    Mitsubishi Fuso Recalls FEC9T Trucks for Loose Front Leaf Spring Bolts

    Mitsubishi Fuso is recalling 2020-2021 FEC9T trucks because loose front leaf spring shackle bolts may detach, creating a road hazard and increasing crash risk.

    Product
    MITSUBISHI FUSO — MITSUBISHI FUSO FEC9T
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V583000·2021-07-29

    NRC Recalls 2019-2020 Motorhomes Due to Gas Leak Risk

    NRC is recalling 2019-2020 motorhomes because an overtightened stove bolt may damage the seal, causing a gas leak that increases fire risk.

    Product
    NRC — NRC MOTOR HOME
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0663-2021·2021-07-28

    Shogun-X Capsules Recalled for Undeclared Prescription Drug Ingredients

    Shogun-X capsules have been recalled because they contain undeclared tadalafil, sildenafil, and/or vardenafil—prescription drugs not listed on the label. These are unapproved drugs whose safety and efficacy have not been established.

    Product
    Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0662-2021·2021-07-28

    Krazy Night Capsules Contain Undeclared Prescription Drug Ingredients

    Krazy Night capsules (1-count blister cards and 10-count boxes) are being recalled nationwide because they contain undeclared tadalafil, sildenafil, and/or vardenafil without FDA approval. These unapproved drugs have not undergone safety and efficacy review.

    Product
    Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0686-2021·2021-07-28

    Thumbs Up 7 Black 25K Capsules Recalled for Undeclared Tadalafil

    Nuri Trading LLC is recalling Thumbs Up 7 Black 25K capsules nationwide because they contain undeclared tadalafil, an FDA-approved drug. The product was marketed without required approval, making it an unapproved drug with unestablished safety and efficacy.

    Product
    Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0682-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Chemical Contamination

    Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer Aloe Watermelon Lemonade due to contamination with methanol, benzene, and acetaldehyde. The 3.38 FL. OZ. bottles were distributed nationwide.

    Product
    Goose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 814630 02423 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0685-2021·2021-07-28

    Shogun-X 7000 Capsules Recalled for Undeclared Prescription Drug Ingredients

    Nuri Trading LLC is recalling Shogun-X 7000 capsules nationwide because they contain undeclared tadalafil and sildenafil, FDA-approved prescription drugs not listed on the label, making the product an unapproved drug.

    Product
    Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0679-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Methanol and Benzene Contamination

    Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Melon Picnic spray (3.38 FL. OZ., Lot #20259) due to contamination with methanol, benzene, and acetaldehyde.

    Product
    Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02424 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0677-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Methanol and Chemical Contamination

    Goose Creek Hand Sanitizer aloe Dragonfruit Splash (3.38 FL. OZ.) is being recalled because the product is contaminated with methanol, benzene, and acetaldehyde. Consumers should stop using the product immediately.

    Product
    Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01332 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0671-2021·2021-07-28

    SS Tangerine & Guava Scented Sanitizer Recalled for Chemical Contamination

    Scentsational Soaps & Candles Inc is recalling SS Tangerine & Guava Scented Sanitizer (3.38 FL. OZ.) due to contamination with methanol, benzene, and acetaldehyde. The product was distributed nationwide.

    Product
    SS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0693-2021·2021-07-28

    Compounded Lyophilized AOD-9604 Injection Recalled for Sterility Risk

    Innoveix Pharmaceuticals is recalling compounded lyophilized AOD-9604 3 mg injection vials nationwide due to lack of assurance of sterility. The affected product was distributed as Rx-only injectable medication.

    Product
    Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0670-2021·2021-07-28

    SS Lemon Zest Scented Sanitizer contaminated with methanol and benzene

    Scentsational Soaps & Candles Inc is recalling SS Lemon Zest Scented Sanitizer due to contamination with methanol, benzene, and acetaldehyde. The affected product was distributed nationwide.

    Product
    SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V576000·2021-07-28

    New Flyer Recalls 2021 XD35 and XD40 Buses for Fuel Leak Risk

    New Flyer is recalling 2021 XD35 and XD40 buses with Cummins L9 engines due to a potential fuel hose leak that could cause a fire.

    Product
    NEW FLYER — NEW FLYER XD40, XD35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0684-2021·2021-07-28

    Coconut Stand CoCo TKO Hand Sanitizer Contaminated with Methanol, Benzene, Acetaldehyde

    Scentsational Soaps & Candles Inc is recalling Coconut Stand CoCo TKO Hand Sanitizer due to contamination with methanol, benzene, and acetaldehyde. The product was distributed nationwide in 3.4 FL. OZ. bottles.

    Product
    Coconut Stand CoCo TKO Hand Sanitizer, Totally Knocks Out 99.9% of Germs, 3.4 FL. OZ. (100.55 mL), Distributed by: Beauty Sparks LLC St. Petersburg, FL 33711
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0681-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Chemical Contamination

    Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray (3.38 FL. OZ.) is being recalled nationwide because it is contaminated with methanol, benzene, and acetaldehyde.

    Product
    Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02045 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0666-2021·2021-07-28

    Ulta Beauty Hand Sanitizer Spray Recalled for Chemical Contamination

    Ulta beauty Fresh Lemon Citron Frais Hand Sanitizer Spray is being recalled because the product contains methanol, benzene, and acetaldehyde. Affected lot numbers are 20357A, 20358B, and 20363C with expiration date 12/1/2022.

    Product
    Ulta beauty Fresh Lemon Citron Frais, 70% Alcohol Hand Sanitizer Spray, Net Wt. 100.55/3.4 fl. oz., UPC 717897092017
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0688-2021·2021-07-28

    69MODE Blue 69 Capsules Recalled for Undeclared Drug Ingredients

    Nuri Trading LLC is recalling 69MODE Blue 69 capsules nationwide because they contain undeclared tadalafil and sildenafil, two FDA-approved drugs, making the product an unapproved drug without established safety or efficacy.

    Product
    69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0676-2021·2021-07-28

    Goose Creek Hand Sanitizer Spray Recalled for Chemical Contamination

    Goose Creek Hand Sanitizer aloe Champagne Bubbles spray (3.38 FL. OZ.) has been recalled because it is contaminated with methanol, benzene, and acetaldehyde. Consumers should stop using the product immediately.

    Product
    Goose Creek Hand Sanitizer aloe Champagne Bubbles, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01334 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0673-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Chemical Contamination

    Goose Creek Hand Sanitizer aloe Limoncello (100 mL) is being recalled because the product contains methanol, benzene, and acetaldehyde. Consumers should stop using the product immediately.

    Product
    Goose Creek Hand Sanitizer aloe Limoncello, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL),Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 18489 01333 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0667-2021·2021-07-28

    SS Coconut Breeze Scented Sanitizer Recalled for Chemical Contamination

    SS Coconut Breeze Scented Sanitizer has been recalled due to contamination with methanol, benzene, and acetaldehyde. The 3.38 FL. OZ. bottles were distributed nationwide.

    Product
    SS Coconut Breeze Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL), a) Black and White Collection; b) Photo Real Collection
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2074-2021·2021-07-28

    Philips Respironics V60 Plus Ventilator software defect reduces oxygen delivery to patients

    Respironics V60 Plus Ventilators (software versions 3.00 and 3.10) may reduce oxygen flow below clinical settings, risking oxygen desaturation and hypoxemia in mechanically ventilated patients.

    Product
    Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0669-2021·2021-07-28

    SS Lavender & Herbs Scented Sanitizer Recalled for Chemical Contamination

    Scentsational Soaps & Candles Inc is recalling SS Lavender & Herbs Scented Sanitizer due to contamination with methanol, benzene, and acetaldehyde. The affected product was distributed nationwide.

    Product
    SS Lavender & Herbs Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0790-2021·2021-07-28

    Circle K Chicken Salad Sandwich Recall Due to Listeria Risk

    LSG Sky Chefs is recalling Circle K Chicken Salad Sandwiches because the chicken used is subject to a national recall due to potential Listeria monocytogenes contamination. The recall affects products with best buy dates of 6/7/21 through 7/9/21 distributed in AZ, CA, and NV.

    Product
    Circle K Chicken Salad Sandwich, 5.9 oz. (167g) clamshell packaging with tamper strip, UPC 815138013996, Manufactured By: LSG Sky Chefs Supply Chain Solutions, Inc. 3555 S. 28th St. Phoenix, AZ. Perishable/Keep Refrigerated.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0664-2021·2021-07-28

    Thumbs Up 7 Red Capsules Recalled for Undeclared Active Pharmaceutical Ingredients

    Ummzy LLC is recalling Thumbs Up 7 Red 70K capsules because they contain undeclared tadalafil and/or sildenafil and vardenafil, making them unapproved drugs with unestablished safety and efficacy.

    Product
    Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0692-2021·2021-07-28

    Compounded Semorelin/Ipamorelin Injection Recalled for Sterility Assurance

    Innoveix Pharmaceuticals is recalling 728 vials of compounded Semorelin/Ipamorelin 3 mg injection due to lack of assurance of sterility. The affected lots are SIP215, SIP220, and SIP210.

    Product
    Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0672-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Chemical Contamination

    Goose Creek Hand Sanitizer aloe Blueberry Limeade spray has been recalled due to contamination with methanol, benzene, and acetaldehyde. The product should not be used.

    Product
    Goose Creek Hand Sanitizer aloe Blueberry Limeade, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 14630 02049 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0687-2021·2021-07-28

    Thumbs Up 7 White Capsules Recalled for Undeclared Pharmaceutical Ingredients

    Nuri Trading LLC is recalling Thumbs Up 7 White 11K capsules nationwide because they contain undeclared prescription drug ingredients (tadalafil, sildenafil, and vardenafil) and lack FDA approval.

    Product
    Thumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0675-2021·2021-07-28

    Goose Creek Hand Sanitizer Spray Recalled for Chemical Contamination

    Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Grape Soda spray because it contains methanol, benzene, and acetaldehyde. The contaminated product was distributed nationwide.

    Product
    Goose Creek Hand Sanitizer aloe Grape Soda, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01328 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0683-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Methanol and Benzene Contamination

    Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Tropical Daydream spray due to contamination with methanol, benzene, and acetaldehyde. The product was distributed nationwide.

    Product
    Goose Creek Hand Sanitizer aloe Tropical Daydream, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01335 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0680-2021·2021-07-28

    Goose Creek Hand Sanitizer Contaminated With Methanol, Benzene, Acetaldehyde

    Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Optimistic Vibes spray due to contamination with methanol, benzene, and acetaldehyde. The product was distributed nationwide.

    Product
    Goose Creek Hand Sanitizer aloe Optimistic Vibes, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02234 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2073-2021·2021-07-28

    Philips Respironics V60 Ventilator Flow Rate Reduction Safety Defect

    Philips Respironics V60 ventilators with High Flow Therapy software versions 3.00 and 3.10 may reduce oxygen delivery below prescribed levels when pressure limits are reached, risking oxygen desaturation.

    Product
    Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0668-2021·2021-07-28

    SS Eucalyptus Mint Scented Sanitizer Recalled for Chemical Contamination

    Scentsational Soaps & Candles Inc is recalling SS Eucalyptus Mint Scented Sanitizer due to contamination with methanol, benzene, and acetaldehyde. The affected product was distributed nationwide.

    Product
    SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL), a) Black and White Collection; b) Photo Real Collection
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0678-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Chemical Contamination

    Goose Creek Hand Sanitizer aloe Marshmallows (3.38 FL. OZ.) is recalled nationwide due to contamination with methanol, benzene, and acetaldehyde. Consumers should stop using the product immediately.

    Product
    Goose Creek Hand Sanitizer aloe Marshmallows, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01331 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0674-2021·2021-07-28

    Goose Creek Hand Sanitizer recalled for methanol and benzene contamination

    Goose Creek Hand Sanitizer aloe Beach Dreams spray (3.38 FL. OZ.) is being recalled because it is contaminated with methanol, benzene, and acetaldehyde. The product was distributed nationwide.

    Product
    Goose Creek Hand Sanitizer aloe Beach Dreams, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandles.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 18489 01336 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2021·2021-07-28

    DJO Surgical EMPOWR 3D Knee Tibial Insert packaging may contain wrong implant size

    Packaging for DJO Surgical EMPOWR 3D Knee Tibial Insert knee prosthesis implants may be mislabeled, with 12mm packages potentially containing 16mm implants or vice versa, risking incorrect surgical implantation.

    Product
    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2021·2021-07-28

    Exactech Hip Implant Liners Recalled Due to Premature Wear Risk

    Exactech is recalling 89,050 Connexion GXL acetabular polyethylene hip implant liners due to risk of premature prosthesis wear in certain patient configurations and surgical positioning scenarios.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm ID. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2021·2021-07-28

    MTS Set dialysis accessory recalled for freezing temperature exposure during transport

    Fresenius is recalling MTS Sets distributed to Texas due to exposure to freezing temperatures from refrigerated truck malfunctions. This exposure may compromise the sterility of the device.

    Product
    The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2122-2021·2021-07-28

    Hip Implant Liners Recalled Due to Risk of Premature Wear

    Exactech Connexion GXL hip implant liners are being recalled due to a risk of edge-loading and premature prosthesis wear in patients with certain implant configurations and surgical positioning.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped Ant, 36mm; and Novation GXL Liner, Lipped, 36mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2130-2021·2021-07-28

    Exactech Connexion GXL hip implant liners risk edge-loading and wear

    Exactech Connexion GXL acetabular polyethylene liners used in hip replacements may experience edge-loading and premature wear in certain patients due to implant configuration or surgical positioning. Approximately 89,050 units were distributed nationwide.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V575000·2021-07-28

    Forest River Recalls 2021 Prime Time Tracer Trailers Due to Tail Light Defect

    Forest River is recalling 2021 Prime Time Tracer TRT22RBS recreational trailers because the tail light is located too close to the water heater exhaust, which may cause the light to fail.

    Product
    PRIME TIME — PRIME TIME TRACER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2021·2021-07-28

    Fresenius Sterile Stay Safe Cap Recalled for Freezing Temperature Exposure

    Fresenius recalls 39 cases of Sterile Stay Safe Caps (lot numbers B1ZH191, B1ZI092) distributed to Texas due to exposure to freezing temperatures during refrigerated truck malfunction, which may have compromised product sterility.

    Product
    050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the s
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2133-2021·2021-07-28

    Hip implant acetabular liners recalled for edge-loading and premature wear

    Exactech Connexion GXL acetabular polyethylene liners for hip implants are recalled due to risk of edge-loading and premature wear in certain patient configurations and implant positions. Approximately 89,050 units distributed nationwide are affected.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2125-2021·2021-07-28

    Exactech Connexion GXL hip implant liners recalled for premature wear risk

    Exactech is recalling 89,050 hip implant liners due to edge-loading and premature wear risk in a subset of patients with certain implant configurations.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation GXL Liner, +5mm Lateralized, G00, 22mm ID. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2096-2021·2021-07-28

    Mediana Vital Signs Monitor May Fail to Power Up or Respond

    Mediana AVSM3 SNF vital signs monitors may fail to power up or have unresponsive button controls, potentially preventing patient vital sign monitoring. The company is recalling 618 units distributed in Wisconsin.

    Product
    AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2095-2021·2021-07-28

    Infant Heel Warmer Recalled Due to Risk of Rupture and Contents Splashing

    Cardinal Health is recalling 2.9 million infant heel warmers that may rupture or leak during activation, potentially splashing heated contents onto infants' eyes or skin and causing rash, burn, or inflammation.

    Product
    Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2021·2021-07-28

    Stryker Cortoss Bone Augmentation Material Recalled for Temperature Storage Violation

    Stryker Spine recalled Cortoss Bone Augmentation Material due to a 12-hour temperature excursion at the distribution center that could have compromised product sterility and efficacy.

    Product
    Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2088-2021·2021-07-28

    Fresenius APD Luer-Lock Adapter Recalled Due to Freezing Temperature Exposure

    Fresenius Medical Care is recalling 5 cases of the APD Luer-Lock Adapter (Lot 20LR08111) distributed in Texas after exposure to freezing temperatures during truck transport. Freezing may have compromised device sterility and functionality.

    Product
    The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, N
    Category
    Medical Device
    Distribution
    1 state
  • HighCPSC·21171·2021-07-28

    Children's Pajamas Recalled for Flammability Standard Violation

    Tkala Fashion children's pajamas fail to meet federal flammability standards for sleepwear, posing a burn injury risk. About 6,000 units sold on Amazon from January through June 2021 are affected.

    Product
    Children's Pajamas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V577000·2021-07-28

    2022 Kia Telluride Instrument Cluster Display May Go Blank

    Certain 2022 Kia Telluride vehicles have instrument cluster displays that may go blank after startup, potentially hiding critical driving information like speed and gear selection. Kia will update the software at no cost.

    Product
    KIA — KIA TELLURIDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2082-2021·2021-07-28

    Hemodialysis concentrate recalled for freezing exposure during transport

    Fresenius Medical Care recalls Granuflo and Naturalyte hemodialysis concentrate affected by freezing temperatures during refrigerated truck transport. Freezing may compromise product sterility and safety.

    Product
    (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunct
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2126-2021·2021-07-28

    Exactech GXL Hip Implant Liners Recalled for Premature Wear Risk

    Exactech is recalling its Connexion GXL acetabular polyethylene liners used in hip implants because they may experience edge-loading and premature wear in certain patient configurations and surgical positioning. A total of 89,050 units were distributed nationwide.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner, +5mm Lateralized, G0, 22mm ID. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2021·2021-07-28

    Infant Heel Warmer Units Recalled for Rupture and Chemical Splashing Risk

    Cardinal Health is recalling 926,425 infant heel warmers (SKU MH00002T) due to reports of pack rupture or leaking during activation. The heated liquid may splash into a user's eyes or onto an infant, potentially causing rash, burn, or inflammation.

    Product
    Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2084-2021·2021-07-28

    Hemodialysis Acid Concentrates Recalled After Freezing Exposure During Transport

    Fresenius Medical Care is recalling Citrasate and GranuFlo Dry Acid Concentrates after freezing temperature exposure during refrigerated truck transport. Affected lots distributed in Texas should be discontinued immediately.

    Product
    Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0784-2021·2021-07-28

    Pow Pow Powders Vanilla Chai Powder Recalled for Undeclared Milk Allergen

    San Diego Coffee, Tea and Spice is recalling Pow Pow Powders Vanilla Chai because the product lacks ingredient and allergen labeling, leaving milk allergen undeclared. The recall affects smoothie mixes distributed in California.

    Product
    Pow Pow Powders: A standard of Quality Vanilla Chai; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Fat Dry Milk, Non-Dairy Creamer (coconut oil, Corn Syrup Solids, Sodium Caseinate (a milk derivative), Sodium Citrate, Mono and Diglycerides, Salt), Instant Black Tea, Honey,
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0785-2021·2021-07-28

    Pow Pow Powders Hot Cocoa Mix Recalled for Undeclared Milk Allergen

    San Diego Coffee, Tea and Spice is recalling Pow Pow Powders hot cocoa mix because the product lacks ingredient and allergen labeling, with undeclared milk present in the formulation.

    Product
    Pow Pow Powders: A standard of Quality Hot Cocoa Mix; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Dairy Creamer (coconut oil, Corn Syrup Solids, Sodium Caseinate (a milk derivative), Sodium Citrate, Mono and Diglycerides, Salt), Cocoa (processed with alkali) Non-Fat Dry
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2127-2021·2021-07-28

    Exactech Connexion GXL Hip Implant Liners Recall Risk of Premature Wear

    Exactech is recalling 89,050 Connexion GXL acetabular hip implant liners due to risk of edge-loading and premature wear in certain patient configurations and surgical placements.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0794-2021·2021-07-28

    MCT Powder 70% from Coconut Recalled for Milk Allergen

    Nutralliance Inc is recalling Medium Chain Triglyceride (MCT) Powder 70% from Coconut distributed in bulk to supplement manufacturers because an ingredient tested positive for milk allergen.

    Product
    Medium Chain Triglyceride (MCT) Powder 70% from Coconut / CocoTrim packaged in 20 kilogram brown bags with plastic inner lining for bulk sale to supplement manufacturers. Exclusively Distributed by Nutralliance / Manufactured by Bio-gen Extracts Pvt. Ltd. Store tightly sealed con
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2128-2021·2021-07-28

    Hip Implant Liners Recalled Due to Premature Wear Risk

    Exactech Connexion GXL acetabular polyethylene liners used in hip replacement systems are recalled due to risk of edge-loading and premature wear in certain patients. The 89,050 affected units were distributed nationwide.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized, 36mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2100-2021·2021-07-28

    Cortoss Bone Augmentation Material Recalled Due to Storage Temperature Excursion

    Stryker Spine is recalling 559 units of Cortoss Bone Augmentation Material 5cc Cartridges due to a 12-hour temperature excursion at the distribution center. The affected lot may not meet required storage conditions.

    Product
    Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2083-2021·2021-07-28

    Drain Bag Set for Peritoneal Dialysis Exposed to Freezing During Transport

    A Drain Bag Set used in peritoneal dialysis was exposed to freezing temperatures due to refrigerated truck malfunction during distribution. The affected lot was distributed to Texas.

    Product
    The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects t
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2116-2021·2021-07-28

    Hip Implant Acetabular Liners Recalled for Premature Wear Risk

    Exactech Connexion GXL acetabular polyethylene liners used in orthopedic hip implants are recalled due to risk of edge-loading and premature wear in certain configurations. The recall affects 89,050 units distributed nationwide.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28mm; and Novation GXL Neutral Liner, G0, 28mm ID. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2124-2021·2021-07-28

    Hip implant liners recalled for edge-loading and premature wear

    Exactech Connexion GXL hip implant liners are recalled due to risk of edge-loading and premature wear in certain configurations. About 89,050 units distributed nationwide are affected.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Liner, 28mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2021·2021-07-28

    Knee Prosthesis Recall: Packaging Mixup May Cause Wrong Size Implantation

    Encore Medical recalls DJO Surgical EMPOWR 3D knee prosthetic components because packaging labels may not match the product inside, risking implantation of incorrect prosthesis sizes.

    Product
    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2080-2021·2021-07-28

    Multiple Brands of Cotton Pads Recalled for Mold Contamination Risk

    Medline Industries is recalling multiple brands of cotton pads and rounds due to potential mold contamination. The affected products were distributed nationwide and internationally for use in cosmetic and personal care applications.

    Product
    Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft and strong 100 count; 2. BEAUTY 360 Premium Cotton Rounds - two textures soft and strong 240 count; 3. BEAUTY 360 Patterned Basic Cotton Rounds - multipurpos
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0788-2021·2021-07-28

    Heidi's Brownies Recalled for Undeclared Soy Allergen

    Heidi's Brownies are being recalled because soy lecithin is listed in the ingredients but soy is not mentioned in the allergen declaration on the label, posing a risk to people with soy allergies.

    Product
    Heidi's Brownies is packaged in saran wrap in a plastic bag with a twist tie, 3 oz (85g). Label is read in parts: "***Heidi's ~~~ Brownies ~~~ *Malted barley wheat flour, cane sugar, water, chocolate chips (unsweetened chocolate, sugar, dextrose, soy lecithin (an emulsifier)(may
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0793-2021·2021-07-28

    MCT Powder 50% from Coconut Recalled for Undeclared Milk Allergen

    Nutralliance Inc is recalling Medium Chain Triglyceride (MCT) Powder 50% from Coconut because an ingredient tested positive for milk allergen. The product was distributed nationwide and to Canada for bulk sale to supplement manufacturers.

    Product
    Medium Chain Triglyceride (MCT) Powder 50% from Coconut / CocoTrim packaged in 20 kilogram brown bags with plastic inner lining for bulk sale to supplement manufacturers. Exclusively Distributed by Nutralliance / Manufactured by Bio-gen Extracts Pvt. Ltd. Store tightly sealed con
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2091-2021·2021-07-28

    Backflush Brush Needles Recalled Due to Incorrect Gauge Labeling

    Dutch Ophthalmic USA is recalling Disposable Replacement Backflush Brush Needles (lot 3420011396) distributed in IL, IN, MO, and PA because the label incorrectly identifies the gauge as 20 gauge/0.9mm when the product is actually 23 gauge/0.6mm.

    Product
    Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2132-2021·2021-07-28

    Exactech Hip Implant Liners Recalled Due to Premature Wear Risk

    Exactech is recalling Connexion GXL hip implant liners due to edge-loading and premature wear risk in certain patient configurations. The recall affects 89,050 units distributed nationwide.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2093-2021·2021-07-28

    Laboratory Information System SoftGenomics Recalled for Displaying Incorrect Results

    SoftGenomics version 4.1.15.6, a laboratory information system used in clinical laboratories, has been recalled due to reports that the software displays incorrect results and PDF reports do not match the hospital information system.

    Product
    SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and tra
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2121-2021·2021-07-28

    Exactech GXL Acetabular Hip Implant Liners Recalled for Premature Wear Risk

    Exactech, Inc. is recalling 89,050 Connexion GXL and Novation GXL acetabular hip implant liners due to risk of edge-loading and premature prosthesis wear in certain patients. The risk depends on implant configuration and surgical positioning.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0783-2021·2021-07-28

    Pow Pow Powders Mocha Latte Recall for Undeclared Milk Allergen

    San Diego Coffee, Tea and Spice is recalling Pow Pow Powders Mocha Latte because the product lacks ingredient and allergen labeling and contains undeclared milk.

    Product
    Pow Pow Powders: A standard of Quality Mocha Latte; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Dairy Creamer (coconut oil, Corn Syrup Solids, Sodium Caseinate (a milk derivative), Sodium Citrate, Mono and Diglycerides, Salt and sodium Aluminosilicate), Non-Fat Dry Milk,
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2099-2021·2021-07-28

    Medical Device Calibration Standard Assigned Incorrectly in NEFA CAL Kit

    Randox Laboratories recalls NEFA CAL IVD calibration standard kits (Batch 544642) due to incorrectly assigned calibration values that could cause measurement errors up to 8% in quality control and patient test results.

    Product
    NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2086-2021·2021-07-28

    Medical dialysis concentrates recalled for freezing temperature exposure

    Fresenius Medical Care recalls Citrasate and NaturaLyte hemodialysis acid concentrates due to exposure to freezing temperatures during refrigerated truck transport. The affected products were distributed exclusively to Texas.

    Product
    Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for us
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0782-2021·2021-07-28

    Pow Pow Powders Spice Chai Recall: Undeclared Milk Allergen

    San Diego Coffee, Tea and Spice is recalling Pow Pow Powders Spice Chai because the product lacks required ingredient and allergen labeling, with milk present but undeclared. Consumers with milk allergies are at risk.

    Product
    Pow Pow Powders: A standard of Quality Spice Chai; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Dairy Creamer (coconut oil, Corn Syrup Solids, Sodium Caseinate (a milk derivative), Sodium Citrate, Mono and Diglycerides, Salt and sodium Aluminosilicate), Non-Fat Milk, Insta
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2131-2021·2021-07-28

    Exactech Hip Implant Liners Recalled Due to Premature Wear Risk

    Exactech is recalling certain acetabular polyethylene hip implant liners due to risk of edge-loading and premature wear in specific implant configurations and surgical positions.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2113-2021·2021-07-28

    Exactech Connexion GXL hip implant liners recalled due to premature wear risk

    Exactech is recalling 89,050 Connexion GXL hip implant liners distributed nationwide due to a risk of edge-loading and premature wear in certain patient implant configurations.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2021·2021-07-28

    Exactech Connexion GXL Hip Implant Liners Risk Premature Wear

    Exactech hip implant liners may experience premature wear and edge-loading in certain patient configurations, according to this Class II recall of 89,050 units distributed nationwide.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2021·2021-07-28

    Moderna COVID-19 Vaccine Administration Kits Recalled for Unsuitable Syringes

    McKesson is recalling 53,388 Moderna COVID-19 vaccine administration kits due to unsuitable 3mL syringes included in the kits. The affected kits were distributed May 4-24, 2021, and should not be used for vaccine administration.

    Product
    ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the COVID-19 vaccine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2021·2021-07-28

    SoftCytogenetics Software Recalled for Incorrect Test Result Transmission

    Soft Computer Consultants, Inc. is recalling SoftCytogenetics software (versions 4.1.11.20, 4.1.12.11, 4.1.15.6) distributed in CA, FL, MN, and NJ because it produces incorrect results for retested specimens that are transmitted to clinical information systems.

    Product
    SoftCytogenetics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21172·2021-07-28

    Birkenstock Kids' Mogami Sandals Recalled for Choking Hazard

    Birkenstock USA has recalled Kids' Mogami Sandals in sizes 24-28 because a plastic rivet can detach from the ankle strap, posing a choking hazard for young children. No injuries have been reported.

    Product
    Birkenstock Kids' Mogami Sandals Sizes 24-28
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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