The Recall Desk

Archive

November 2020 recalls

382 recalls were announced in November 2020.

What the numbers show

Critical
11
Severe
85
High
183
Moderate
78
Low
25

Of the 382 recalls this month scored against our rubric, 3% are Critical, 22% are Severe.

1–100 of 382

  • SevereNHTSA·20V741000·2020-11-30

    Mitsubishi Recalls 2016 Outlander Models for Parking Brake Corrosion Risk

    Mitsubishi is recalling 2016 Outlander and Outlander Sport vehicles because rust prevention coating on parking brake shafts may peel, causing corrosion and potential brake failure.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER SPORT, OUTLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V742000·2020-11-30

    2021 Freightliner Cascadia clutch defect may cause disengagement

    Daimler Trucks North America is recalling 2021 Freightliner Cascadia trucks due to a manufacturing defect in the clutch assembly that may cause the clutch to disengage, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V740000·2020-11-30

    Triumph Rocket 3 Motorcycles Recalled for Air in Antilock Brake System

    Triumph is recalling certain 2020-2021 Rocket 3 motorcycles because air may have entered the rear brake ABS modulator during production. This can reduce braking efficiency over time, increasing stopping distance and crash risk.

    Product
    TRIUMPH — TRIUMPH ROCKET 3 TFC, ROCKET 3 R, ROCKET 3 GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·027-2020·2020-11-26

    Tarantino Wholesale Foods Recalls Undercooked Ready-to-Eat Chicken Breast

    Tarantino Wholesale Foods is recalling ready-to-eat chicken breast products that may be undercooked, posing a risk of bacterial pathogens.

    Product
    Producers Meat & Provision — Tarantino Wholesale Foods Distributor Recalls Ready-to-Eat Chicken Breast Products That May be Undercooked
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0124-2021·2020-11-25

    National Food Trading Recalls Frozen Green Beans for Listeria Risk

    National Food Trading Corporation is recalling 28,262 lbs of frozen French cut green beans due to possible Listeria monocytogenes contamination.

    Product
    Frozen French Cut Green Beans. Packaged in 20.5 lb boxes. Expiration date 11/25/2022
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0079-2021·2020-11-25

    Hand Sanitizer Recalled for Methanol Contamination and Low Ethanol Content

    Albek De Mexico S.A. De C.V. is recalling Modesa Instant Hand Sanitizer because it contained methanol and had lower ethanol content than labeled.

    Product
    Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0081-2021·2020-11-25

    Hand Sanitizer Recalled for Methanol Contamination and Low Ethanol Content

    Albek De Mexico is recalling Assured Instant Hand Sanitizer bottles because they contained methanol and had lower ethanol levels than labeled.

    Product
    Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0117-2021·2020-11-25

    Trader Joe's Gluten Free Battered Halibut Recalled for Undeclared Wheat and Milk

    Orca Bay Foods LLC is recalling Trader Joe's Gluten Free Battered Halibut because the retail packaging fails to declare wheat and milk allergens.

    Product
    Trader Joe's brand Gluten Free Battered Halibut, SKU 00503822. Product of USA. Frozen product is packed in plastic bag and sold in retail carton box (10 oz. box). Each master case contains 20/10 oz. boxes. RETAIL BOX'S label is read in parts: '***TRADER JOE'S BATTERED HALIBUT
    Category
    Food
    Distribution
    19 states
  • SevereFDA (Drugs)·D-0082-2021·2020-11-25

    Next Advanced Antibacterial Hand Sanitizer Recalled for Methanol Contamination

    Albek De Mexico S.A. De C.V. is recalling Next Advanced Antibacterial Hand Sanitizer because it contained methanol and had lower ethanol levels than labeled.

    Product
    NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0078-2021·2020-11-25

    Hand Sanitizer Recalled for Methanol Contamination and Low Ethanol Content

    Albek De Mexico S.A. De C.V. is recalling NuuxSan hand sanitizer because it contained methanol and had lower ethanol levels than labeled.

    Product
    NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0077-2021·2020-11-25

    Preferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets Due to NDMA

    Preferred Pharmaceuticals is recalling 99 bottles of Metformin HCl Extended Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) levels exceeding the Acceptable Daily Intake Limit.

    Product
    Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·20V739000·2020-11-25

    Peterbilt 520 Recalled for Incorrect Brake Relay Connections

    PACCAR is recalling 2020-2021 Peterbilt 520 vehicles because incorrectly connected brake components may destabilize the vehicle during stability control events, increasing crash risk.

    Product
    PETERBILT — PETERBILT 520
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0080-2021·2020-11-25

    Assured Instant Hand Sanitizer Recalled for Methanol Contamination

    Albek De Mexico S.A. De C.V. is recalling 27,000 bottles of Assured Instant Hand Sanitizer because the product contained methanol and was below the label claim for ethanol content.

    Product
    Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0097-2021·2020-11-25

    Ascent Pharmaceuticals Recalls Hydrocodone and Acetaminophen Tablets Due to Foreign Tablet

    Ascent Pharmaceuticals is recalling 9,768 bottles of Hydrocodone Bitartrate and Acetaminophen Tablets because one bottle contained a Losartan Potassium tablet.

    Product
    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722, NDC 31722-943-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·21036·2020-11-25

    Santa Cruz Recalls 2020 Aluminum Bicycles Due to Frame Buckling Risk

    Santa Cruz Bicycles is recalling about 2,900 model year 2020 aluminum frames because thermal damage can cause them to bend or buckle, posing a fall hazard.

    Product
    Model Year 2020 Aluminum Santa Cruz and Juliana Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0151-2021·2020-11-25

    Mayer Brothers Recalls Apple Cider Due to Pasteurization Error

    Mayer Brothers Apple Products is recalling specific apple cider products because a processing error mixed pasteurized and raw cider. Consumers in MD, MA, and MI should check their products.

    Product
    1. Giant brand " Premium Apple Cider*** 64 fl. oz. (Half Gal) 1.89L***Distributed by Foodhold USA LLC, Landover, MD 20785" 2. "Nature's Nectar 100% Fresh Apple Cider***128 fl. oz.***Distributed by Aldi, Inc. Batavia, IL 60510" 3. Open Acres Honeycrisp Apple Cider, 128 fl.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0118-2021·2020-11-25

    Rosebud's Elderberry Syrup Kit Recalled for Potential Salmonella Contamination

    Rosebud's Ranch and Garden, LLC is recalling 41 units of Elderberry Syrup Kits due to potential salmonella contamination in the elderberries.

    Product
    Rosebud's brand Elderberry Syrup Kit in a 3 oz. clear stand-up pouch (GS1 Code 852782007834).
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0461-2021·2020-11-25

    Roche Recalls cobas infinity Software Due to Incorrect Validation

    Roche Diagnostics is recalling 40 cobas infinity central lab licenses because an erroneous QC status may cause incorrect validation of results.

    Product
    cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V736000·2020-11-25

    GM Recalls 2015-2016 Silverado and Sierra Trucks for Air Bag Defect

    General Motors is recalling 2015-2016 Chevrolet Silverado and GMC Sierra trucks because the roof-rail air bag inflator end cap may detach, posing an injury risk.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 1500, SIERRA 1500, SIERRA 2500, SIERRA 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2021·2020-11-25

    GE v|tome|x L Series X-ray Systems Recalled for Warning Signal Defect

    GE Inspection Technologies is recalling v|tome|x L Series X-ray systems because pre-warning signals may fail to activate if the warm-up mode is not completed.

    Product
    v|tome|x L Series non-destructive testing cabinet x-ray systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0472-2021·2020-11-25

    Mako MICS Handpiece Recalled for Potential Bone Preparation Discrepancies

    Stryker is recalling Mako MICS Handpieces due to a characterization issue that may cause unsuccessful checkpoint verification or bone cuts differing from the preoperative plan.

    Product
    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to ex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21033·2020-11-25

    Herobility Eco Baby Spoons and Feeding Sets Recalled for Choking Hazard

    Herobility is recalling Eco Baby Spoons, Forks, and Feeding Sets because they can break into small pieces, posing a choking hazard. No injuries have been reported.

    Product
    Baby Spoons and Forks, Feeding Spoons and Placemat Feeding sets 4PCs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V737000·2020-11-25

    Audi recalls S5, A5, and RS5 for rear wiring defect

    Volkswagen Group (Audi) is recalling 2020-2021 S5, A5, and RS5 vehicles due to missing anti-abrasion protection on rear light wiring. In a crash, exposed wires may be damaged, potentially disabling door locks and hazard lights.

    Product
    AUDI — AUDI A5, RS 5, S5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2021·2020-11-25

    Siemens Atellica IM 1300 Analyzer Recalled for Test Definition Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers because scanning specific test definitions may reset custom settings, causing inaccurate test results.

    Product
    Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21034·2020-11-25

    RH Recalls Wine Barrel Chandeliers Due to Falling Hardware Hazard

    RH is recalling approximately 7,800 wine barrel chandeliers because hanging hardware can break, causing the fixture to fall. No injuries have been reported.

    Product
    Wine Barrel Chandeliers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2021·2020-11-25

    Medicrea Ligapass Tension Pulley Handle Recalled for Band Breakage Risk

    Medicrea International is recalling Ligapass Tension Pulley Handles because the instrument can crush the band, causing it to break during surgery and leading to infection risk.

    Product
    MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0453-2021·2020-11-25

    Cardinal Health Recalls Kangaroo Connect 1000ml Bag Sets Due to Leak Risk

    Cardinal Health 200, LLC is recalling Kangaroo Connect 1000ml Bag Sets because the feeding spike sets may leak at the tube and spike connector interface.

    Product
    Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V734000·2020-11-25

    Toyota RAV4 and Avalon Steering Column Airbag Failure Recall

    Certain 2020-2021 Toyota RAV4, RAV4 Hybrid, Avalon, and Avalon Hybrid vehicles may have damaged steering column breakaway pins that could reduce airbag performance in a crash. Toyota will replace the steering column at no cost.

    Product
    TOYOTA — TOYOTA AVALON, RAV4, RAV4 HYBRID, AVALON HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V735000·2020-11-25

    Front Seat Bolts May Not Be Installed Properly in 2021 Chevrolet Tahoe

    Front seat attachment bolts may not have been properly installed on certain 2021 Chevrolet Tahoe, Suburban, and GMC Yukon models. If loose or missing, the seats could move during a crash, increasing injury risk.

    Product
    GMC — GMC, CHEVROLET YUKON, YUKON XL, TAHOE, SUBURBAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0454-2021·2020-11-25

    MeritMedical Cultura Flex Swab Recall Due to Tip Breakage Risk

    Merit Medical Systems is recalling Cultura Flex Swabs because the flocked tip may break off during use, potentially causing soft tissue injury or treatment delays.

    Product
    MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0120-2021·2020-11-25

    John Nagle Steelhead Fillets Recalled for Listeria Contamination Risk

    John Nagle Co. is recalling steelhead fillets that may be contaminated with Listeria monocytogenes. The product was distributed in Massachusetts, New York, Pennsylvania, and Ohio.

    Product
    John Nagle Steelhead Fillets; 1/3 lb; Iceland; N44515; Habrun ehf; Packaging date: 29 10 2020
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0449-2021·2020-11-25

    Thomas Scientific Recalls Wuxi Nest Patient Specimen Collection Tubes

    Thomas Scientific is recalling Wuxi Nest patient specimen collection tubes to replace units manufactured and distributed prior to Enforcement Discretion Approval.

    Product
    Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2021·2020-11-25

    Merit Medical Cultura Collection and Transport System Swab Tip Breakage Recall

    Merit Medical is recalling Cultura Collection and Transport Systems because the swab tip may break off during sample collection, potentially causing soft tissue injury.

    Product
    Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2021·2020-11-25

    Cardinal Health Recalls Kangaroo Connect 500ml Bag Sets Due to Leakage

    Cardinal Health is recalling Kangaroo Connect 500ml Bag Sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V733000·2020-11-25

    Renegade Motorhomes Recalled for Gas Leak Risk in Cooking Stove

    Kibbi is recalling certain 2019-2021 Renegade motorhomes with Dometic cooking stoves due to a potential gas leak from an overtightened saddle valve bolt, which could increase fire risk. Dealers will install repair kits free of charge.

    Product
    RENEGADE — RENEGADE VERONA LE, VERONA, VALENCIA, CLASSIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0457-2021·2020-11-25

    Stryker Recalls Osteosynthesis Compression Staple EasyClip Devices

    Stryker GmbH is recalling EasyClip and EasyClip Xpress staples due to potential nickel release above safety margins in pediatric patients under 20 kg.

    Product
    Osteosynthesis Compression Staple EasyClip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0116-2021·2020-11-25

    Art Of Tea Feel Better tea recalled for potential Salmonella

    Art Of Tea is recalling Feel Better tea due to potential Salmonella contamination in elder berries. Consumers should stop using the product.

    Product
    Art Of Tea - Feel Better tea; Produced and Distributed by: Art of Tea LLC, Monterey Park, CA Directions: 1 Tbsp of tea in 8 oz. of water at 206 degrees; steep for 5-7 minutes. Packaged in: Black Mylar bag with label, Silver Mylar bag with label, Silver Tin Canisters
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-0455-2021·2020-11-25

    Merit Medical Cultura Collection and Transport System recall due to swab tip breakage risk

    Merit Medical recalls its Cultura Collection and Transport System because the swab tip may break off during sample collection, potentially causing soft tissue injury.

    Product
    Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0086-2021·2020-11-25

    Milbar Recalls DCL SA Scalp Therapy Shampoo Due to GMP Deviations

    Milbar Laboratories is recalling 1,815 bottles of DCL SA Scalp Therapy Shampoo due to Good Manufacturing Practice (GMP) deviations.

    Product
    DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486503120
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0460-2021·2020-11-25

    Exactech Equinoxe Cage Glenoid Posterior Augment Recalled for Mislabeling

    Exactech is recalling 40 Equinoxe Cage Glenoid, Posterior Augment, Right, Medium devices due to potential mislabeling. The devices were distributed to US and international consignees.

    Product
    Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Food)·F-0119-2021·2020-11-25

    FreshPoint Roma Diced Tomatoes Recalled for Potential Foreign Material

    FreshPoint Dallas is recalling specific lots of Roma diced tomatoes due to potential foreign material. The products were distributed in Texas and Kansas.

    Product
    FC TOMATOES ROMA DICED 3/8" 1/5#; FC TOMATOES ROMA DICED 3/8" 4/5#, and FC TOMATOES ROMA DICED 3/8" 2/5# all packaged in white plastic trays with heat seal lid, packed inside a cardboard box
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0093-2021·2020-11-25

    Milbar Recalls Willa Pore Perfector Pads Due to GMP Deviations

    Milbar Laboratories is recalling 2,638 jars of Willa Pore Perfector pads due to Good Manufacturing Practice deviations. The product was distributed nationwide and internationally.

    Product
    Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0469-2021·2020-11-25

    Siemens Artis X-Ray Systems Recalled for Overvoltage Protection Defect

    Siemens is recalling 26 Artis X-ray systems worldwide because incorrect diodes may fail to protect against overvoltage, potentially causing system malfunction.

    Product
    Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0088-2021·2020-11-25

    Milbar Recalls Malin + Goetz Dandruff Shampoo Due to GMP Deviations

    Milbar Laboratories is recalling 5,312 bottles of Malin + Goetz dandruff shampoo due to Good Manufacturing Practice deviations.

    Product
    (Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione Zinc) 8 fl.oz bottle, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0122-2021·2020-11-25

    Denali Coffee Cream Stabilizer Recalled for Ingredient Substitution

    Denali Ingredients LLC is recalling 3,050 lbs of Supreme1251 Coffee Cream Stabilizer because it was made with Citric Acid instead of Sodium Citrate.

    Product
    Denali Ingredients Supreme1251Coffee Cream Stabilizer, Item 501251-1014, 50 lb. bag. Storage: For maximum Performance Store at Ambient Temperatures Below 85F. This container is intended for Food Products Only. No other Use Authorized. Dispose of in an Approved Manner.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0459-2021·2020-11-25

    Exactech Equinoxe Cage Glenoid Posterior Augment Recalled for Mislabeling

    Exactech, Inc. is recalling 69 Equinoxe Cage Glenoid, Posterior Augment, Left, Medium devices because they may be mislabeled.

    Product
    Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-0450-2021·2020-11-25

    Ortho Recalls VITROS SARS-CoV-2 IgG Calibrators Due to Elevated Signal Values

    Ortho Clinical Diagnostics is recalling specific lots of VITROS SARS-CoV-2 IgG Calibrators because they produced elevated signal values. The recall also includes one lot of IgG Controls with decreased signal.

    Product
    VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized labora
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0092-2021·2020-11-25

    Milbar Recalls Willa Clear Skin Salicylic Acid Tubes Due to GMP Deviations

    Milbar Laboratories is voluntarily recalling 4,855 tubes of Willa Clear Skin (Salicylic Acid 2%) due to Good Manufacturing Practice (GMP) deviations. The product was distributed nationwide and internationally.

    Product
    Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist. Chandler, AZ 85226
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0083-2021·2020-11-25

    Milbar Recalls DCL Active Mattifying Cleanser Due to GMP Deviations

    Milbar Laboratories is recalling 4,878 tubes of DCL Active Mattifying Cleanser due to Good Manufacturing Practice (GMP) deviations. The product was distributed nationwide and internationally.

    Product
    DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486509627
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0101-2021·2020-11-25

    Hikma Recalls Sodium Chloride Injection Vials Due to pH Failures

    Hikma Pharmaceuticals is recalling specific lots of Sodium Chloride Injection USP 0.9% 2 mL vials because they failed pH specifications.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0096-2021·2020-11-25

    Milbar Recalls Salicylic Acid Shampoo Due to GMP Deviations

    Milbar Laboratories is recalling Salicylic Acid Shampoo 3% due to Good Manufacturing Practice deviations. The product was distributed in the US and internationally.

    Product
    Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0468-2021·2020-11-25

    Strauss 25 Carbide Dental Burs Recalled for Incorrect Packaging

    Coltene Whaledent Inc is recalling Strauss 25 Carbide Dental Burs because they were incorrectly packaged as a different model, posing a risk of excessive material removal.

    Product
    Strauss 25 Carbide Dental Burs (100057XXV)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0106-2021·2020-11-25

    Apotex Recalls Aripiprazole Tablets Due to Dissolution Failures

    Apotex Corp. is recalling Aripiprazole Tablets 15 mg because they failed to meet dissolution specifications. The affected products were distributed nationwide in the USA.

    Product
    Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0087-2021·2020-11-25

    Milbar Recalls DCL T Shampoo for GMP Deviations

    Milbar Laboratories is voluntarily recalling 1,225 bottles of DCL T Shampoo due to Good Manufacturing Practice (GMP) deviations.

    Product
    DCL T Shampoo for Hair and Body ( Solution Coal Tar U.S.P. 3% and 0.6% Coal Tar), 300 ml/ 10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 3574865069947
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0440-2021·2020-11-25

    Inova Lasers Recalls Class IV New Era Medical Laser Devices

    Inova Lasers LLC is recalling eight Class IV New Era medical laser devices because they failed to comply with Electronic Product Radiation Control regulations.

    Product
    Class IV New Era medical laser device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0084-2021·2020-11-25

    Milbar Recalls DCL B Prox10 Anti-Blemish Wash Due to GMP Deviations

    Milbar Laboratories is voluntarily recalling 7,591 bottles of DCL B Prox10 Anti-Blemish Wash due to Good Manufacturing Practice (GMP) deviations.

    Product
    DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 0357486500853
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0451-2021·2020-11-25

    Ortho Recalls VITROS Anti-SARS-CoV-2 IgG Control Due to Signal Issues

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Control and Calibrator lots due to elevated signal/cutoff values and decreased signal.

    Product
    VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier): 61999
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0090-2021·2020-11-25

    Milbar Recalls Malin+Goetz SPF 30 Face Moisturizer Due to GMP Deviations

    Milbar Laboratories is recalling 3,692 tubes of Malin+Goetz SPF 30 Face Moisturizer due to Good Manufacturing Practice (GMP) deviations.

    Product
    (Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%, Oxybenzone 5%) 1.7 fl. oz. 50 ml tubes, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0474-2021·2020-11-25

    Siemens Atellica IM 1600 Analyzer Recalled for Custom Settings Reset

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers because scanning a new kit lot may reset custom settings to defaults.

    Product
    Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0094-2021·2020-11-25

    Milbar Recalls DCL Alpha Beta Gel Toner Due to GMP Deviations

    Milbar Laboratories is voluntarily recalling DCL Alpha Beta Gel Toner due to Good Manufacturing Practice (GMP) deviations. The product was distributed nationwide and internationally.

    Product
    DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0462-2021·2020-11-25

    LivaNova VNS Therapy AspireSR Generator Recall for Serial Number Error

    LivaNova is recalling 134 VNS Therapy AspireSR Generators because an extra digit in the serial number makes them incompatible with specific therapy programmers.

    Product
    VNS Therapy¿ AspireSR¿ Generator
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Drugs)·D-0085-2021·2020-11-25

    Milbar Recalls DCL AHA Lightening Gel Due to GMP Deviations

    Milbar Laboratories is recalling 1,608 bottles of DCL AHA Lightening Gel due to Good Manufacturing Practice deviations. The product was distributed nationwide and internationally.

    Product
    DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0099-2021·2020-11-25

    Grato Holdings Recalls Homeopathic Energy Catalyst for Undeclared API

    Grato Holdings is recalling 399 bottles of Homeopathic Energy Catalyst due to an undeclared active pharmaceutical ingredient and incorrect formulation.

    Product
    Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0756-1.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0091-2021·2020-11-25

    Milbar Recalls MD Complete Breakout Treatment Due to GMP Deviations

    Milbar Laboratories is voluntarily recalling 2,655 bottles of MD Complete Breakout Treatment due to Good Manufacturing Practice deviations.

    Product
    MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0095-2021·2020-11-25

    Milbar Recalls DCL Clear Skin Anti-Blemish Hydrator Due to GMP Deviations

    Milbar Laboratories is voluntarily recalling 927 tubes of DCL Clear Skin Anti-Blemish Hydrator due to Good Manufacturing Practice (GMP) deviations.

    Product
    DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0089-2021·2020-11-25

    Milbar Recalls Malin + Goetz Salicylic Gel Due to GMP Deviations

    Milbar Laboratories is recalling 2,664 tubes of Malin + Goetz Salicylic Gel due to Good Manufacturing Practice (GMP) deviations.

    Product
    (Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-0470-2021·2020-11-25

    Micro-Tech Elastic Traction Device Recalled for Regulatory Classification Issues

    Micro-Tech USA is recalling Elastic Traction Devices because they are not appropriately classified as Class I and require 510(k) clearance.

    Product
    Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0471-2021·2020-11-25

    Ortho VITROS Chemistry Performance Verifier II Recalled for Product Instability

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Performance Verifier II due to product instability that causes biased ALKP values.

    Product
    VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0401-2021·2020-11-25

    Merz Recalls COAPTITE Injectable Implant Due to Documentation Mismatch

    Merz North America is recalling 2,051 units of COAPTITE Injectable Implant because the Instructions for Use do not match post-approval study data.

    Product
    COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water
    Category
    Medical Device
    Distribution
    48 states
  • LowFDA (Devices)·Z-0458-2021·2020-11-25

    Steris Olympus Leak Test Adapter Recalled for Cleaning Solution Intrusion Risk

    Steris Corporation is recalling Olympus Leak Test Adapters used with Acu-sInQ systems due to a potential for cleaning solution to intrude into endoscopes.

    Product
    Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0121-2021·2020-11-25

    Denali Ingredients Recalls Sour Cream Stabilizer Due to Ingredient Substitution

    Denali Ingredients LLC is recalling 2,250 lbs of Cream Tech 250 Sour Cream Stabilizer because it was made with citric acid instead of sodium citrate.

    Product
    Denali Ingredients Cream Tech 250 Sour Cream Stabilizer, Item 500120-1014, 50 lb. bag. Storage: For maximum Freshness Store at Ambient Temperatures Below 85F. This container is intended for Food Products Only. No other Use Authorized. Dispose of in an Approved Manner.
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·20V730000·2020-11-24

    Ford Recalls 2020 Explorers Due to Fuel Tank Weld Defect

    Ford is recalling 2020 Explorers with 2.3L engines because an incomplete weld on the fuel tank inlet check valve could cause a fuel leak and fire during a crash.

    Product
    FORD — FORD EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V729000·2020-11-24

    Mercedes-Benz Metris Recalled for Potential Brake Line Fitting Defects

    Daimler Vans USA is recalling 2019-2020 right-hand drive Mercedes-Benz Metris vehicles because brake line fittings may be incorrectly installed, risking fluid leaks and reduced braking performance.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21710·2020-11-24

    Any Volume Recalls Bicycle Helmets Due to Head Injury Risk

    Any Volume is recalling about 660 adult bicycle helmets sold on eBay because they do not comply with U.S. safety standards, posing a risk of head injury.

    Product
    Bicycle Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20E088000·2020-11-24

    Weldon i4G Vivtech Control Panels Recalled for Electrical Defect

    Weldon is recalling i4G Vivtech control panels because an electrical defect may cause the display to stop working, potentially delaying emergency services.

    Product
    ELECTRICAL SYSTEM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V728000·2020-11-23

    Rosenbauer Aerial Vehicles Recalled for Power Take-Off Defect

    Rosenbauer America is recalling 2018-2020 Aerial vehicles because the power take-off may disengage, causing the aerial device to become inoperable.

    Product
    ROSENBAUER — ROSENBAUER AERIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V727000·2020-11-23

    Multiple recreational vehicle models recalled for cooking stove gas leak

    Forest River and Coachmen recreational vehicles with Dometic 3-burner cooking stoves may experience gas leaks from overtightened saddle valve bolts, creating a fire hazard. Owners should contact dealers for a free remedy kit.

    Product
    COACHMEN — COACHMEN, FOREST RIVER, DYNAMAX CROSS TREK, FREELANDER, LEPRECHAUN, MIRADA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-11212020-01·2020-11-21

    Chicken and Beef Samosa Products Recalled for Undeclared Milk Allergen

    USDA FSIS issued a public health alert for Taza and South Asian Food samosas containing spring roll pastry with undeclared milk. Consumers should not eat these products.

    Product
    FSIS Issues Public Health Alert for Chicken and Beef Samosa Products Containing Pastry Ingredients That Have Been Recalled Due to Misbranding
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·20V722000·2020-11-20

    Triple E Recalls Motorhomes Due to Chafed Wire Harness and Tail Light Loss

    Triple E is recalling 2018-2021 Unity and Serenity motorhomes because a shifting water tank bracket can chafe the wire harness, causing tail lights to fail and increasing crash risk.

    Product
    TRIPLE E — TRIPLE E UNITY, SERENITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V720000·2020-11-20

    Isuzu and Chevrolet Trucks Recalled for Battery Cable Fire Risk

    Isuzu and Chevrolet are recalling 2020 NPR-HD and 4500 trucks because a battery cable may overheat near the exhaust, posing a fire risk.

    Product
    ISUZU — ISUZU, CHEVROLET NPR HD, LOW CAB FORWARD 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V721000·2020-11-20

    Isuzu and Chevrolet Recall 2020 Trucks for Wiring Chafe Risk

    Isuzu and Chevrolet are recalling 2020 NPR-HD and 4500 Crew Cab trucks because a chafing wire harness or hose could cause a short circuit, engine stall, or fire.

    Product
    ISUZU — ISUZU, CHEVROLET NPR HD, LOW CAB FORWARD 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V726000·2020-11-20

    2021 Lincoln Aviator steering knuckle defect increases crash risk

    Ford is recalling certain 2021 Lincoln Aviator vehicles due to improperly manufactured steering knuckles that may fracture, reducing steering control and increasing crash risk. Dealers will inspect and replace affected knuckles free of charge.

    Product
    LINCOLN — LINCOLN AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V725000·2020-11-20

    2021 Honda Pilot Tire Safety Recall Due to Over-Curing Defect

    Honda is recalling 2021 Pilot vehicles with certain Continental tires that may be over-cured, potentially causing sidewall breaks or belt separation leading to loss of vehicle control. Dealers will replace affected tires free of charge.

    Product
    HONDA — HONDA PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V719000·2020-11-20

    Newmar Motorhomes Recalled for Cooking Stove Gas Leak Fire Risk

    Newmar motorhomes equipped with Dometic 3-burner cooking stoves may have an overtightened saddle valve bolt that damages the seal, causing a gas leak and increasing fire risk. Owners should contact Newmar for a free remedy.

    Product
    NEWMAR — NEWMAR VENTANA, VENTANA LE, BAY STAR, DUTCH STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V718000·2020-11-19

    2021 Thor Motor Coach Four Winds motorhomes recalled for stove gas leak

    Thor Motor Coach is recalling certain 2021 Four Winds motorhomes with Dometic stoves due to a potential gas leak that could increase fire risk. The stove's saddle valve bolt may be overtightened, damaging the seal.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH FOUR WINDS
    Category
    Vehicle
    Distribution
    Distributed nationwide

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