The Recall Desk

Archive

April 2022 recalls

391 recalls were announced in April 2022.

What the numbers show

Critical
7
Severe
66
High
258
Moderate
58
Low
2

Of the 391 recalls this month scored against our rubric, 2% are Critical, 17% are Severe.

201–300 of 391

  • HighNHTSA·22V253000·2022-04-14

    Ford Recalls 2022 F-150 Trucks for Steering Column Wiring Defect

    Ford is recalling 2022 F-150 vehicles because short steering column wiring may separate, potentially preventing the column from moving correctly in a crash.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22115·2022-04-14

    Shell Diving Inflation Valves Recalled Due to Hypothermia Risk

    SI Tech is recalling approximately 1,670 Shell Diving Inflation Valves with International Nipples used in diving dry suits. The internal valve part can malfunction during use, causing loss of inflation and thermal protection, which poses a risk of hypothermia.

    Product
    Shell Diving Inflation Valves with Int'l Nipples for diving dry suits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·22116·2022-04-14

    FAO Schwarz Toy Wood Play Smart Robot Buddy and Sensory Boards Recalled for Choking Hazard

    MerchSource is recalling about 46,200 FAO Schwarz Toy Wood Play Smart Robot Buddies and Sensory Boards because small parts can come loose, posing a choking hazard to young children.

    Product
    FAO Schwarz Toy Wood Play Smart Robot Buddy(s) and FAO Schwarz Toy Wood Sensory Boards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V248000·2022-04-14

    2022 Jeep Compass recalled for improperly welded seat head restraints

    Chrysler is recalling 114 2022 Jeep Compass vehicles because the front seat head restraints were not properly welded, creating an increased risk of injury during a crash. Dealers will replace both head restraints at no cost.

    Product
    JEEP — JEEP COMPASS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V252000·2022-04-14

    Ford Recalls 2019 F-Series Trucks for Rearview Camera Defect

    Ford is recalling 2019 F-150, F-250, F-350, F-450, and F-550 trucks because a poor electrical connection may cause the rearview camera to display a blank or distorted image, increasing crash risk.

    Product
    FORD — FORD F-450 SD, F-350 SD, F-250 SD, F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V247000·2022-04-14

    2022 Lincoln Aviator Head Restraint Cushions May Detach

    The front-row driver and passenger head restraint cushions in certain 2022 Lincoln Aviators may detach from their assemblies when adjusted fully forward, increasing crash injury risk.

    Product
    LINCOLN — LINCOLN AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22120·2022-04-14

    Dollar Tree Recalls 1 Million Crafter's Square Hot Glue Guns for Fire and Burn Hazards

    Dollar Tree is recalling about 1,025,000 Crafter's Square hot glue guns sold nationwide that can malfunction when plugged in, posing fire and burn hazards. Seven electrical malfunctions have been reported, including four fires and one skin irritation.

    Product
    Crafter's Square Glue Guns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·22119·2022-04-14

    Craftsman and Troy-Bilt Riding Lawn Mowers Recalled for Crash Hazard

    MTD Products is recalling about 6,200 Craftsman 30" Mini and Troy-Bilt TB30 riding lawn mowers because they can fail to stop completely and continue moving at about one mile per hour when the brake pedal is fully pressed.

    Product
    Craftsman 30" Mini and Troy-Bilt TB30 Riding Lawn Mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·22118·2022-04-14

    Hempväna Pain Relief Products with Lidocaine Fail Child-Resistant Packaging Requirement

    Telebrands is recalling four Hempväna pain relief products containing lidocaine because their packaging does not meet child-resistant requirements under the Poison Prevention Packaging Act, posing a poisoning risk to young children.

    Product
    Hempväna Ultra Strength Pain Relief Cream with Lidocaine, Hempväna Ultra Strength Pain Relief Cream Night with Lidocaine, Hempväna Ultra Strength Pain Relief Cream Turmeric with Lidocaine, Hempväna Pain Relieving Hand & Body Lotion with Lidocaine
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0962-2022·2022-04-13

    Yes! Enoki Mushrooms Recalled Due to Listeria monocytogenes Contamination

    T Fresh Company is recalling Yes! Enoki Mushrooms due to Listeria monocytogenes contamination detected in samples. The product was distributed to California, Georgia, and Texas.

    Product
    Yes! Enoki Mushrooms; Pesticide Free Produce: Vacuumed packed. Product of China 5.29 oz. (150g) packaged in pink and transparent plastic package. UPC:825382736718; 7.5 oz. (200g) packed in light blue and transparent plastic package. UPC: 825382736947 Distributed by T Fresh CO.,
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-0974-2022·2022-04-13

    Fresh Harvest Fruit Platter With Raspberry Dip Recalled for Listeria

    Fruit Fresh Up, Inc. is recalling Fresh Harvest Small fruit platters with raspberry dip due to potential Listeria monocytogenes contamination. The recall affects products distributed in NY, MA, and PA.

    Product
    1. Fresh Harvest Small fruit platter w/raspberry dip
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0978-2022·2022-04-13

    Fruit Fresh Up Recalls Bulk Fruit Salad for Potential Listeria Contamination

    Fruit Fresh Up, Inc. is recalling Eden Valley Bulk Fruit Salad which may be contaminated with Listeria monocytogenes. The recall affects 39,232 units distributed in New York, Massachusetts, and Pennsylvania.

    Product
    Eden Valley Bulk Fruit Salad
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0981-2022·2022-04-13

    Doodlebugs Tidbits Mix Recalled Due to Potential Listeria Contamination

    Fruit Fresh Up, Inc. is recalling Doodlebugs Tidbits Mix (cantaloupe, honeydew, pineapple, watermelon) distributed in New York, Massachusetts, and Pennsylvania due to potential Listeria monocytogenes contamination.

    Product
    Doodlebugs 12 # Tidbits Mix (cantaloupe, honeydew, pineapple, watermelon )
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0979-2022·2022-04-13

    Tops Dill Dip Bulk recalled due to Listeria contamination risk

    Tops Dill Dip Bulk is being recalled due to potential contamination with Listeria monocytogenes. Consumers should stop using the product and dispose of it safely.

    Product
    Tops Dill Dip Bulk
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0763-2022·2022-04-13

    FDA Recalls SYMJEPI Epinephrine Injection for Potential Needle Clogging

    Adamis Pharmaceuticals is recalling SYMJEPI epinephrine injections due to potential needle clogging that may prevent medication delivery. The FDA has classified this as a Class I recall affecting nationwide distribution.

    Product
    SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-130-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0980-2022·2022-04-13

    MapleVale 18# Wet Salad Bucket Recalled for Listeria Contamination

    Fruit Fresh Up, Inc. recalls MapleVale 18# Wet Salad Bucket due to potential Listeria monocytogenes contamination. Affected products were distributed in New York, Massachusetts, and Pennsylvania.

    Product
    MapleVale 18# Wet Salad Bucket Cut Cantaloupe, Honeydew, Pineapple, Grapes in Watermelon Juice with Potassium sorbate added.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0972-2022·2022-04-13

    Fruit Fresh Up melon trio and combo products recalled for Listeria contamination

    Melon trio and combo products from Fruit Fresh Up may contain Listeria monocytogenes. Products distributed in NY, MA, and PA with best-by dates from March 5–23, 2022 are affected.

    Product
    1. Wegmans 32oz Melon Trio 2.Fresh Harvest 18oz Melon Trio 64779300400 3. Lexington Co-op 32oz Melon Trios 64779300403 4. Lexington Co-op 10oz Melon Combo 64779300370 5. Tops Large Mixed Melon 6. Tops Small Mixed Melon
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0976-2022·2022-04-13

    Lexington Co-op and EDU Kids Honeydew Products Recalled for Listeria

    Fruit Fresh Up, Inc. recalls honeydew products that may contain Listeria monocytogenes. Affected products with best-by dates 03/05/2022–03/23/2022 were distributed in NY, MA, and PA.

    Product
    1. Lexington Co-op 10oz Honeydew Chunk (2/cs) 2. EDU Kids 2 oz Honeydew tidbits
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·22V241000·2022-04-13

    New England Wheels Recalls 2021-2022 Frontrunner Buses for Fire Risk

    New England Wheels is recalling 2021-2022 Frontrunner buses because a faulty module may cause a fire. Owners should contact the manufacturer for a free repair.

    Product
    NEW ENGLAND WHEELS — NEW ENGLAND WHEELS FRONTRUNNER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0970-2022·2022-04-13

    Watermelon Products Recalled Due to Potential Listeria Contamination

    Fruit Fresh Up, Inc. recalled watermelon products from multiple retailers due to potential Listeria monocytogenes contamination. The recall affects 39,232 units distributed in NY, MA, and PA with best-by dates of March 5–23, 2022.

    Product
    1. Wegmans 10oz Watermelon Chunks 2. Wegmans 32oz Watermelon Chunks 3.Fresh Harvest 18oz Watermelon Chunks 4. Tops Large Watermelon BBD: 3/5/22 to BBD: 3/22/22 5. Tops Small Watermelon BBD: 3/5/22 to BBD: 3/22/22 6. Lexington Co-op 10oz Watermelon Chunks 7. Lexington Co-o
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0964-2022·2022-04-13

    Top Quality Produce Enoki Mushrooms Recalled for Listeria

    Top Quality Produce Enoki Mushrooms are recalled due to Listeria monocytogenes contamination detected by California Department of Public Health. The recall affects 1108 cases distributed across six states.

    Product
    Top Quality Produce Enoki Mushrooms; 200G/7.05 oz. clear package with green bottom. Vacuumed packed Product of Taiwan. Keep Refrigerated, Cook before Eating. UPC: 848180019661 50 bags per box Distributed by: Top Quality Produce, Inc., Irwindale, CA 91706
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0764-2022·2022-04-13

    SYMJEPI Epinephrine Injection Recalled for Defective Delivery System Nationwide

    Adamis Pharmaceuticals is recalling 2,500 cartons of SYMJEPI (epinephrine injection) nationwide due to a defective delivery system that may clog the needle and prevent medication dispensing.

    Product
    SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-131-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·22E032000·2022-04-13

    NTN Driveshaft Recall: Improper Heat Treatment May Cause Failure

    NTN Bearing Corporation is recalling specific driveshafts because internal components may not have been heat-treated properly. This defect could lead to driveshaft failure and a sudden loss of drive power.

    Product
    POWER TRAIN:DRIVELINE:DRIVESHAFT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V238000·2022-04-13

    Lexus Recalls 2022 NX Models for Front Shock Absorber Weld Defect

    Lexus is recalling 2022 NX250, NX350, NX350h, and NX450h+ vehicles because missing spot-welds may cause the front shock absorber to separate, increasing crash risk.

    Product
    LEXUS — LEXUS NX350H, NX250, NX450H+, NX350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0977-2022·2022-04-13

    Fruit Fresh Up Raspberry Dip Recalled Due to Listeria Contamination Risk

    Fruit Fresh Up, Inc. is recalling Fruit Fresh Up Raspberry Dip (7oz) due to potential Listeria monocytogenes contamination. Affected units distributed in NY, MA, and PA should not be consumed.

    Product
    Fruit Fresh Up Raspberry Dip (7oz)
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0971-2022·2022-04-13

    Multiple Brands of Pineapple Spears and Chunks Recalled for Listeria Contamination

    Fruit Fresh Up is recalling multiple pineapple products sold under various store brands due to potential Listeria monocytogenes contamination. Affected products were distributed in New York, Massachusetts, and Pennsylvania with best-by dates from March 5 to March 23, 2022.

    Product
    1. Wegmans 32oz Pineapple Spears 2. Fresh Harvest 18oz Pineapple Spears 3. Fresh Harvest 6# Pine Bucket 4. Tops Small Pineapple 5. Lexington Co-op 10oz Pineapple chunks 6. Lexington Co-op 32oz Pineapple Spears 7. EDU Kids 2 oz. Pineapple tidbits
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0973-2022·2022-04-13

    Multiple cantaloupe products recalled due to potential Listeria contamination

    Fruit Fresh Up, Inc. is recalling six cantaloupe products distributed in NY, MA, and PA (39,232 units) due to potential Listeria monocytogenes contamination. Products have best-by dates between March 5 and March 26, 2022.

    Product
    All BBD 03/05/22 through 03/23/2022 1. Wegmans 32oz Cantaloupe Spears 2. Fresh Harvest 18oz Cantaloupe Spears 3. Tops Large Cantaloupe 4. Tops Small Cantaloupe 5. Lexington Co-op 10oz Cantaloupe Chunk (4/cs) 6. EDU Kids 2 oz. Cantaloupe tidbits
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0966-2022·2022-04-13

    Bread Alone Fruit & Nut Sourdough recalled for undeclared sulfites

    Bread Alone, Inc. is recalling Fruit & Nut Sourdough bread because it contains undeclared sulfites. The affected product includes all loaves with expiration dates through March 28, 2022, distributed in New York, Massachusetts, and Connecticut.

    Product
    Bread Alone Fruit & Nut Sourdough; packaged in 27 ounce plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0975-2022·2022-04-13

    Fresh Harvest veggie platter recalled for possible Listeria contamination

    Fruit Fresh Up, Inc. is recalling Fresh Harvest Small veggie platters with ranch that may be contaminated with Listeria monocytogenes. Affected products were distributed in New York, Massachusetts, and Pennsylvania.

    Product
    Fresh Harvest Small veggie platter w/ranch 64779300337
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0961-2022·2022-04-13

    Asian Style Noodle Salad recalled for possible plastic contamination

    GH Foods GA is recalling 1,421 units of Asian Style Noodle Salad because an ingredient may contain clear plastic objects. The product was distributed in Georgia and South Carolina.

    Product
    Asian Style Noodle Salad, Net Wt 1lb (16oz) 453 g PERISHABLE, KEEP REFRIGERATED CONTAINS: SOY, TREE NUTS (ALMONDS), WHEAT. Distributed By: Renaissance Food Group, LLC 4222 Moreland Avenue, Conley, GA 30286 UPC 8 26766 14888 1
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0741-2022·2022-04-13

    Tetracaine Injection Recalled for Sterility Assurance Manufacturing Defect

    Tetracaine 1% Injectable is being recalled due to sterility assurance failures caused by manufacturing deviations that may compromise product sterility.

    Product
    TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V240000·2022-04-13

    2022-2023 BMW iX Air Bag Warning System Software Defect

    BMW is recalling 2022-2023 iX vehicles due to incorrect software in the air bag control unit. The malfunction indicator light may not illuminate if the air bag system has a problem, increasing crash injury risk.

    Product
    BMW — BMW IX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22E033000·2022-04-13

    Bendix Brake Light Switch Recall Due to Binding Connection

    Bendix is recalling brake light switches that may bind, causing lights to stay on or fail to illuminate, increasing crash risk.

    Product
    EXTERIOR LIGHTING:BRAKE LIGHTS:SWITCH recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0759-2022·2022-04-13

    Pfizer Recalls Blood Pressure Tablets Due to Manufacturing Defects

    Pfizer is recalling quinapril HCl/hydrochlorothiazide tablets due to manufacturing defects that allowed N-nitroso impurities to exceed acceptable daily intake limits. Patients taking affected lots should contact their pharmacy.

    Product
    quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0748-2022·2022-04-13

    Prescription Eye Drop Medication Recalled for Subpotency and Contamination

    Mylan Pharmaceuticals recalls one lot of Travoprost ophthalmic solution due to subpotency and impurity issues found during stability testing. Patients should consult their pharmacist or physician if they have medication from this lot.

    Product
    TRAVOPROST OPHTHALMIC SOLUTION, 0.004% — TRAVOPROST OPHTHALMIC SOLUTION, 0.004% (TRAVOPROST OPHTHALMIC SOLUTION, 0.004%)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0746-2022·2022-04-13

    Diabetes Drug Janumet Recalled Due to Stainless Steel Contamination

    Merck is recalling 3,600 cartons of Janumet (sitagliptin/metformin HCl) tablets nationwide due to the presence of stainless steel particulates in the tablets.

    Product
    JANUMET — JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0754-2022·2022-04-13

    Pfizer recalls Accuretic blood pressure tablets for impurities exceeding acceptable limits

    Pfizer is recalling 53 bottles of Accuretic blood pressure tablets nationwide due to manufacturing impurities that exceed FDA acceptable daily intake limits. The affected lot is FG5379, expiring August 2024.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-3112-23.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0755-2022·2022-04-13

    Pfizer Accuretic Blood Pressure Tablets Recalled for Chemical Impurity

    Pfizer is recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets nationwide due to unacceptable levels of N-nitroso chemical impurities from manufacturing deviations. The affected lot includes 160 bottles.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0887-2022·2022-04-13

    Surgical drive mechanism recalled due to corrosion risk

    Maquet Cardiovascular is recalling the Ultima Activator II Reusable Drive Mechanism due to potential corrosion on pins, which could cause allergic reactions, metal toxicity, and other delayed health effects.

    Product
    Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0879-2022·2022-04-13

    DeRoyal Ultra/Mammo Tray Medical Kits Recalled for Unvalidated Manufacturing Test Methods

    DeRoyal Industries is recalling 780 Ultra/Mammo Tray kits with antiseptic swabs due to uncertain validation of manufacturing test methods. Kits are used for patient skin preparation before surgery or injection.

    Product
    DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0859-2022·2022-04-13

    GE SIGNA Excite 3T MRI Systems Recalled Over Potential Image Flip

    GE Healthcare is recalling 55 SIGNA Excite 3T MRI systems due to potential for images to be flipped left to right, which could affect diagnostic accuracy. The affected systems were distributed worldwide.

    Product
    SIGNA Excite 3T. Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2022·2022-04-13

    GE Healthcare MRI Systems May Display Flipped Images Affecting Diagnosis

    GE Healthcare's 1.5T and 3.0T SIGNA Excite HD MRI systems may display medical images flipped left to right, potentially affecting diagnostic accuracy. The recall involves 76 units distributed worldwide.

    Product
    1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0737-2022·2022-04-13

    Philips StentBoost Live imaging system acquisition malfunction recall

    Philips Healthcare is recalling the StentBoost Live R2.0 application due to a software configuration error. The imaging system fails to stop image acquisition automatically, continuing indefinitely while the pedal is pressed instead of stopping after 40 images.

    Product
    Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0881-2022·2022-04-13

    Philips HeartStart HS1 AED Pads: Potential Gel Separation Defect

    Philips is recalling adult Smart PADS cartridges for HeartStart HS1 defibrillators due to potential gel separation from the pad backing. Affected pads may have reduced gel contact, potentially affecting device performance.

    Product
    Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2022·2022-04-13

    Neurological surgical kits may have compromised packaging sterility

    Stradis Medical is recalling Surgicare Neuro Pack neurological kits because the outer bag may be perforated or torn, potentially compromising product sterility. 176 units were distributed in Indiana, Texas, and Pennsylvania.

    Product
    Surgicare Neuro Pack - Neurological Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V245000·2022-04-13

    2021-2022 Volkswagen Atlas Fuel Injector Fire Risk Recall

    Volkswagen is recalling 2021-2022 Atlas and Atlas Cross Sport vehicles because some fuel injectors lack filters, potentially causing fuel leaks and increasing fire risk. Dealers will replace affected injectors at no cost.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS CROSS SPORT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0865-2022·2022-04-13

    Anterior Hip Surgical Kit Recall Due to Potential Sterility Breach

    Stradis Medical is recalling Anterior Hip Pack surgical kits due to perforated or torn outer bags that may compromise sterility. No illnesses have been reported.

    Product
    Anterior Hip Pack - Surgical Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0882-2022·2022-04-13

    Philips infant/child defibrillator pads recalled for gel separation defect

    Philips is recalling 331,712 infant and child defibrillator pads worldwide due to potential gel separation from the pad backing. The gel may fold onto itself or separate nearly completely, leaving reduced surface coverage on the pad.

    Product
    Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0860-2022·2022-04-13

    GE Healthcare MRI Systems Recalled Due to Potentially Flipped Images

    GE Healthcare has recalled 653 SIGNA MRI systems worldwide due to a potential defect that could flip medical images left to right. This could affect diagnostic accuracy in patient care.

    Product
    1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2022·2022-04-13

    Draeger Babylog VN500 Ventilators Recalled for Cybersecurity Vulnerability

    Draeger Medical is recalling Babylog VN500 ventilators for neonatal and pediatric patients due to cybersecurity vulnerabilities. The devices are not equipped against potential cyber threats.

    Product
    Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2022·2022-04-13

    C-Peptide ELISA Kit Recalled Due to Defective Standards

    DRG International recalls its C-Peptide ELISA kit (Catalog # EIA-1293) after the standards were found to have optical density below the required threshold. The defect may cause invalid test runs and delayed patient results.

    Product
    C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0898-2022·2022-04-13

    Medline Excelsior Medical Sterile Saline Flush Syringes Recalled for Sterility Failure

    Medline Industries is recalling 7,800 Excelsior Medical 10mL Sterile Field Saline Flush syringes due to sterility failure of the exterior syringe surface, which may prevent the product from being safely used on a sterile field.

    Product
    Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2022·2022-04-13

    Abbott Alinity m HBV Device Misquantitation of Negative Samples

    Abbott Molecular recalled Alinity m HBV Application Specification Files due to potential for incorrect high quantitation results on negative samples, which could affect test accuracy for hepatitis B virus detection.

    Product
    Alinity m HBV Application Specification File (US and CE)
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0890-2022·2022-04-13

    Customized Brius orthodontic devices recalled for design control failure

    Brius Technologies is recalling 13 customized metal orthodontic appliances that were sold and distributed prior to completing the required design control process and documentation.

    Product
    Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2022·2022-04-13

    Stradis Medical Anesthesia Kit Recalled Due to Sterility Breach Risk

    Stradis Medical is recalling Lum Lam Custom Pack Anesthesia Kits because the outer bag may be perforated or torn, potentially compromising the kit's sterility. Two lot numbers are affected.

    Product
    Lum Lam Custom Pack - Anesthesia Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2022·2022-04-13

    DeRoyal DEXMED Access Center Tray Recalled for Manufacturing Test Validation Uncertainty

    DeRoyal Industries is recalling 1,360 DEXMED ACCESS CENTER TRAY kits with Prevantics antiseptic swabs due to uncertain validation of manufacturing test methods. The affected kits were distributed in Florida, New Jersey, and Tennessee.

    Product
    DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0893-2022·2022-04-13

    SPECT/CT Imaging Systems Recalled Due to Defective Balancing Weight Bolts

    Siemens is recalling seven Symbia Intevo SPECT/CT imaging systems due to a quality defect in the bolts that secure the CT balancing weights, which could create a safety issue.

    Product
    Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0967-2022·2022-04-13

    Powerade Zero Grape recalled for undeclared sugar content

    Powerade Zero Grape 20oz bottles in 24-variety packs are recalled because they contain undeclared sugar. The product is marketed as zero-sugar, making this labeling error significant for consumers managing sugar intake.

    Product
    Powerade Zero - Grape 20oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety pack
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0757-2022·2022-04-13

    Accuretic Blood Pressure Tablets Recalled for Excess Chemical Impurity

    Pfizer is recalling Accuretic blood pressure tablets due to manufacturing deviations that resulted in N-nitroso chemical impurities exceeding safe intake limits. Patients should contact their pharmacist or physician.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0969-2022·2022-04-13

    Thai Noodle Salad Kit Recalled for Potential Plexiglass Contamination

    Taylor Farms Southwest is recalling Thai Noodle Salad Kits (108 oz bags) due to potential contamination with plexiglass pieces supplied by an ingredient vendor. Consumers should not consume the affected product.

    Product
    Thai Noodle Salad Kit 108 oz. bag (behind the counter salad), UPC 0 30223 11270 9, Taylor Farms Southwest, 859 S. 86th Ave, Tolleson, AZ 85353. Perishable, refrigerate until consumption.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0963-2022·2022-04-13

    Caesar Dressing in 1.5 oz Pouch Recalled for Undeclared Soy Allergen

    Caesar dressing in 1.5 oz pouches manufactured by Sauer Brands Inc is being recalled due to undeclared soy. The product was distributed to institutional foodservice accounts in 14 states and poses a risk to people with soy allergies.

    Product
    Caesar dressing in a 1.5 oz pouch
    Category
    Food
    Distribution
    14 states
  • HighFDA (Drugs)·D-0753-2022·2022-04-13

    FDA Recalls Orphenadrine Citrate Tablets Due to Nitrosamine Impurity

    Sandoz is recalling Orphenadrine Citrate Extended-Release Tablets due to nitrosamine impurity levels exceeding acceptable daily limits. Affected patients should consult their healthcare provider.

    Product
    ORPHENADRINE CITRATE — ORPHENADRINE CITRATE (ORPHENADRINE CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0743-2022·2022-04-13

    Phenobarbital Sodium Injection Recalled for Sterility Assurance Deviations

    Vitae Enim Vitae Scientific is recalling Phenobarbital Sodium Injection nationally due to deviations from manufacturing practices that compromise sterility assurance on this injectable drug.

    Product
    PHENOBARBITAL SODIUM — PHENOBARBITAL SODIUM (PHENOBARBITAL SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0761-2022·2022-04-13

    Accuretic tablets recalled for N-nitroso impurities exceeding safe limits

    Pfizer is recalling 195 bottles of Accuretic blood pressure tablets nationwide due to N-nitroso impurities exceeding acceptable daily intake limits. No illnesses have been reported.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 .
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0744-2022·2022-04-13

    Phenobarbital Sodium Injection recalled for manufacturing sterility defect

    Vitae Enim Vitae Scientific, Inc. is recalling Phenobarbital Sodium Injection nationwide due to deviations from Current Good Manufacturing Practices (CGMP) that raise concerns about product sterility.

    Product
    PHENOBARBITAL SODIUM — PHENOBARBITAL SODIUM (PHENOBARBITAL SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0760-2022·2022-04-13

    Pfizer Recalls Quinapril/Hydrochlorothiazide Tablets for N-Nitroso Impurities

    Pfizer is recalling 1,104 bottles of quinapril/hydrochlorothiazide tablets due to nitrosamine impurities above acceptable limits. The affected lot (DP3414) was distributed nationwide.

    Product
    quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V242000·2022-04-13

    2022 Crossroads Zinger Travel Trailers Recalled for Missing Furnace Vent

    Keystone RV is recalling 2022 Crossroads Zinger travel trailers because the furnace vent extension may not have been installed. A missing vent can allow carbon monoxide to enter the living area.

    Product
    CROSSROADS — CROSSROADS ZINGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0742-2022·2022-04-13

    Drug recall: Papaverine hydrochloride injection due to sterility concerns

    Vitae Enim Vitae Scientific, Inc. is recalling papaverine hydrochloride injection nationwide due to manufacturing deviations that compromise sterility assurance in this intravenous drug product.

    Product
    PAPAVERINE HYDROCHLORIDE — PAPAVERINE HYDROCHLORIDE (PAPAVERINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0756-2022·2022-04-13

    Accuretic Tablets Recalled Due to Excess N-Nitroso Impurity

    Pfizer is recalling Accuretic (quinapril/hydrochlorothiazide) tablets nationwide due to N-nitroso impurities exceeding acceptable daily intake limits. The impurity resulted from a manufacturing deviation.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0220-23.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2022·2022-04-13

    X-ray System Radiation Dose May Exceed Safety Limits in Some Modes

    Shimadzu SonialVision safire X-ray systems may emit radiation exceeding federal limits during some fluoroscopic procedures. The manufacturer is addressing installation criteria to prevent potential dose violations.

    Product
    MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0866-2022·2022-04-13

    Surgical kit recall due to outer bag perforation and sterility risk

    Stradis Medical is recalling 348 units of its Total Joint Pack Surgical Kit due to risk of outer bag tears or perforations that could compromise kit sterility. The recall affects units distributed in Indiana, Texas, and Pennsylvania.

    Product
    Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2022·2022-04-13

    SyncVision Systems cardiac imaging measurement error in same-session workflow

    SyncVision cardiac imaging systems may display incorrect measurements during same-session procedures if workflow steps are performed out of order, potentially affecting patient treatment.

    Product
    SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0884-2022·2022-04-13

    Alinity m HBV AMP Kit Recalled for Risk of Falsely High Test Results

    Abbott Molecular is recalling the Alinity m HBV AMP Kit due to potential for falsely high results on negative samples. The kits are used for Hepatitis B virus testing in the US and internationally.

    Product
    Alinity m HBV AMP Kit (US and CE)
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0815-2022·2022-04-13

    CT Scanner Dose Display Error in GE Healthcare Revolution Systems

    GE Healthcare Revolution Apex and Revolution CT systems display accumulated radiation doses inaccurately high in certain situations. No injuries have been reported.

    Product
    Revolution Apex, Revolution CT with Apex Edition
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0892-2022·2022-04-13

    Unauthorized SARS-CoV-2 Antigen Tests recalled for lack of FDA clearance

    WHPM Inc. is recalling approximately 535,755 First SIGN SARS-CoV-2 Antigen Tests distributed in California, Florida, Louisiana, Massachusetts, and Texas. The tests were sold without FDA Emergency Use Authorization or clearance.

    Product
    First SIGN SARS-CoV-2 Antigen Test
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0877-2022·2022-04-13

    Panther Fusion GBS Assay Cartridges Recalled for False Negative Results

    Hologic is recalling 2,061 Panther Fusion GBS Assay Cartridges because samples at or near the limit of detection may produce false negative results, risking missed diagnosis of group B streptococcus infection.

    Product
    Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-0870-2022·2022-04-13

    Draeger Evita V500 Ventilator Cybersecurity Vulnerability Affects Patient Safety

    Draeger Medical is recalling Evita V500 ventilators due to cybersecurity vulnerabilities that could potentially compromise device functionality. Affected units require software remediation.

    Product
    Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2022·2022-04-13

    DeRoyal ST Neonatal Dressing Change Kit recalled for unvalidated manufacturing test methods

    DeRoyal Industries is recalling 400 DeRoyal ST Neonatal Dressing Change Kits due to uncertain validation of manufacturing test methods. The recall affects kits distributed to healthcare facilities in Florida, New Jersey, and Tennessee.

    Product
    DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0864-2022·2022-04-13

    Total Knee Surgical Kit Recall Due to Potential Sterility Breach

    Stradis Medical is recalling 76 units of Total Knee Surgical Kits with potentially perforated or torn outer bags that may compromise sterility. Distribution occurred in Indiana, Texas, and Pennsylvania.

    Product
    Total Knee Pack - Surgical Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2022·2022-04-13

    Abbott ARCHITECT STAT myoglobin calibrators recalled for calibration failure

    Abbott is recalling 402 kits of ARCHITECT STAT myoglobin calibrator that failed stability testing and may produce out-of-specification calibration results. The affected calibrators could impact the accuracy of myoglobin measurements used in clinical diagnostics.

    Product
    ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2022·2022-04-13

    Cardiohelp-i Transport Guard Pin Defect May Prevent Device Opening

    Maquet Medical Systems is recalling certain Cardiohelp-i Transport Guard units due to a potential loose cylindrical pin that may jam the locking mechanism. This could prevent the device from opening or cause complete disassembly, potentially delaying critical cardiac support.

    Product
    Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2022·2022-04-13

    CT Scanner Dose Display Shows Inaccurate Values in Certain Situations

    GE Healthcare Revolution CT scanners display inaccurate radiation dose values in certain situations. This could affect clinical dosing decisions during patient scans.

    Product
    Revolution CT, Revolution CT ES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2022·2022-04-13

    Defibrillator devices unapproved for US market recalled by FDA

    Remote Diagnostic Technologies recalls Tempus LS defibrillators not approved for US distribution. Two units were distributed in Illinois and Kansas.

    Product
    Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2022·2022-04-13

    X-ray fluoroscopy system may deliver excessive radiation dose

    Shimadzu FLUOROspeed X1 fluoroscopy systems may deliver radiation doses exceeding federal regulatory limits in specific fluoroscopic operating modes due to inadequate installation adjustment criteria.

    Product
    MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
    Category
    Medical Device
    Distribution
    37 states
  • HighNHTSA·22V244000·2022-04-13

    Nissan Recalls 2020 Sentra Vehicles for Headlight Misalignment

    Nissan is recalling 2020 Sentra vehicles with LED headlights because the right-hand headlight may be misaligned, potentially reducing visibility and increasing crash risk.

    Product
    NISSAN — NISSAN SENTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V239000·2022-04-13

    Electronic Stability Control Software Defect in 2022 Toyota RAV4 Prime and Other Models

    Certain Toyota and Lexus vehicles may have a software defect preventing the Electronic Stability Control system from re-engaging after being manually disabled. Dealers will update the software free of charge.

    Product
    TOYOTA — TOYOTA, LEXUS SIENNA HYBRID, VENZA HYBRID, MIRAI, redundant VENZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0874-2022·2022-04-13

    Philips Allura and Azurion X-ray systems may display incorrect previous images

    Philips Allura and Azurion X-ray systems running StentBoost Live R2.0 may display images from previous scans or other patients due to a software defect. 338 units are affected and globally distributed.

    Product
    Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V243000·2022-04-13

    Recreational Vehicles LP Gas System Fire Hazard Recall

    Forest River is recalling certain 2021–2023 recreational vehicles because quick disconnect fittings in the LP gas system may crack and leak, creating a fire risk in the presence of an ignition source.

    Product
    COACHMEN — COACHMEN, FOREST RIVER, PRIME TIME FREELANDER, IMPRESSION, LACROSSE, SANIBEL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0868-2022·2022-04-13

    X-ray System Models Recalled for Potential Radiation Dose Exceeding Standards

    Shimadzu Medical Systems recalls 176 SonialVision G4 X-ray systems that may emit radiation doses exceeding federal standards in some fluoroscopic mode cases. No injuries have been reported.

    Product
    MODEL: X-RAY TV SYSTEM SONIALVISION G4
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0857-2022·2022-04-13

    Signa 1.5T MRI System Recall: Potential Horizontal Image Reversal

    GE Healthcare is recalling 10 Signa 1.5T TwinSpeed MRI systems worldwide due to a potential defect where magnetic resonance images may be flipped left to right.

    Product
    Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0968-2022·2022-04-13

    Asian Style Noodle Salad Recalled for Potential Plastic Foreign Material

    Garden Highway Southwest recalled 141 units of Asian Style Noodle Salad in Texas due to potential plastic contamination. No illnesses have been reported.

    Product
    Asian Style Noodle Salad Net Wt. 1 lb (16 oz) 463 g PERISHABLE KEEP REFRIGERATED packaged in plastic clamshells
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0856-2022·2022-04-13

    Oral gel recalled for failed microbial testing

    SA3, LLC is recalling Silatrix Oral Gel Polymerized Sucralfate Gel due to failed microbial testing. Consumers should not use the product and contact their healthcare provider or SA3, LLC.

    Product
    Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0758-2022·2022-04-13

    Quinapril and Hydrochlorothiazide Tablets Recalled for Elevated Chemical Impurity

    Pfizer is recalling quinapril and hydrochlorothiazide tablets (20 mg/25 mg) nationwide due to elevated chemical impurities exceeding acceptable daily intake limits. No illnesses have been reported.

    Product
    quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0889-2022·2022-04-13

    Brius Patient Specific Brackets recalled without completing design control process

    Brius Technologies is recalling Brius Patient Specific Brackets that were sold before the company completed the required design control process and regulatory documentation.

    Product
    Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0762-2022·2022-04-13

    Risedronate Sodium Tablets Recalled for Failed Content Uniformity Specifications

    Macleods Pharma USA Inc is recalling Risedronate Sodium 5 mg tablets (Lot BRD2001A, expiration 5/2022) due to failed content uniformity specifications. The recall affects 4,872 bottles distributed nationwide.

    Product
    RISEDRONATE SODIUM — RISEDRONATE SODIUM (RISEDRONATE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0747-2022·2022-04-13

    NETSPOT prescription drug kit recalled for subpotency in vial 1

    Advanced Accelerator Applications recalls approximately 14,089 NETSPOT kits distributed nationwide due to subpotency detected during stability studies. The affected lots contain insufficient active ingredient concentration.

    Product
    NETSPOT — NETSPOT (68GA-DOTATATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0752-2022·2022-04-13

    FDA Voluntary Recall of Methylprednisolone Tablets for Subpotency

    Jubilant Cadista Pharmaceuticals is recalling Methylprednisolone Tablets USP 4mg because they contain less active ingredient than labeled. Lot 21 P0322 was distributed nationwide and in Puerto Rico.

    Product
    Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0751-2022·2022-04-13

    Oral antiseptic rinse recalled due to label mix-up and wrong barcode

    The Natural Dentist Healthy Breath Antiseptic Rinse (Cool Mint) is being recalled due to a label mix-up. The back label incorrectly states the active ingredient as Peppermint Oil and Sage Oil and displays the wrong UPC code.

    Product
    The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (500 mL, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC Code 714132000714.
    Category
    Drug
    Distribution
    Distributed nationwide

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