The Recall Desk

Archive

June 2023 recalls

513 recalls were announced in June 2023.

What the numbers show

Critical
13
Severe
177
High
265
Moderate
57
Low
1

Of the 513 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.

Which agencies issued them

201–300 of 513

  • SevereFDA (Food)·F-0985-2023·2023-06-21

    Van Leeuwen ice cream recalled for undeclared walnuts

    Van Leeuwen brand ice cream may contain undeclared walnuts. Consumers with walnut allergies should not consume this product.

    Product
    Van Leeuwen brand BROWN SUGAR CHUNK WITH COOKIE DOUGH & BROWNIES FENCH ICE CREAM; 14 FL OZ (414 ML); ingredients: cream, milk, dark brown sugar, cane sugar, egg yolks, wheat flour, unbleached flour (wheat flour, malted barley flour), water, cocoa processed with alkali, canola oil
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-0874-2023·2023-06-21

    Hand sanitizer recalled nationwide for methanol contamination

    SOFT HANDS Alcohol Antiseptic 80% hand sanitizer is recalled nationwide due to FDA detection of methanol contamination. Approximately 7,303 gallons were distributed with manufacture dates from March to August 2020.

    Product
    SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon / 3785.41ml, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0873-2023·2023-06-21

    Hand Sanitizer Containing Methanol Recalled Due to Chemical Contamination

    Jarman's Midwest Cleaning Systems recalled 2,365 gallons of 80% alcohol antiseptic hand sanitizer nationwide due to FDA-detected methanol contamination. Consumers should stop using affected products immediately.

    Product
    Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2023·2023-06-21

    Medicine Dropper Recalled for Potential Glass Particulate Contamination

    Apothecary Products, LLC is recalling 1,596 units of Medicine Dropper (Lot 021623) due to potential glass particles on the dropper bulb exterior. Glass particles could contaminate medication or cause injury.

    Product
    Medicine Dropper, Product Code K508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1910-2023·2023-06-21

    Aspira Peritoneal Drainage Catheter Insertion Tray valve malfunction

    Merit Medical's Aspira Peritoneal Drainage Catheter Insertion Tray valve assemblies may fail to open, preventing fluid drainage. 175 units distributed nationwide and internationally are affected.

    Product
    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1913-2023·2023-06-21

    Aspira Pleural Drainage Catheter May Fail to Drain Fluid

    Merit Medical Systems is recalling 524 units of the Aspira Pleural Drainage Catheter Insertion Tray due to a defect where valve assemblies may not open, preventing fluid drainage. Affected units were distributed worldwide including across the US, France, UK, and Mexico.

    Product
    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1909-2023·2023-06-21

    FDA Recalls Aspira Peritoneal Drainage Catheter Insertion Tray for Valve Failure

    Merit Medical Systems recalls Aspira Peritoneal Drainage Catheter Insertion Tray due to a potential valve failure that could prevent necessary fluid drainage.

    Product
    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2023·2023-06-21

    bellavista 1000e Ventilator Software May Hang, Affecting Device Interface

    Vyaire Medical is recalling certain bellavista 1000e ventilators due to software issues that may cause the touchscreen to become unresponsive. The recall also addresses potential operator error risks if ventilator settings are not confirmed before application.

    Product
    bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V436000·2023-06-21

    2022 Volkswagen ID.4 Recalled for Rearview Camera Software Defect

    Volkswagen is recalling 2022 ID.4 vehicles with defective rearview camera software. The defect can delay or deactivate the rearview camera image, reducing rear visibility and increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V437000·2023-06-21

    2023 Volkswagen GTI and Golf R suspension strut mount defect

    Volkswagen is recalling certain 2023 GTI and Golf R vehicles due to deformed suspension strut mounts that may loosen and cause steering instability. Dealers will replace affected components at no cost.

    Product
    VOLKSWAGEN — VOLKSWAGEN GOLF R, GTI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0872-2023·2023-06-21

    Hand Sanitizer Recalled Due to Manufacturing Deficiency and Methanol Risk

    Jarman's Midwest Cleaning Systems recalled 1,276 gallons of isopropyl alcohol hand sanitizer nationwide due to manufacturing deficiencies and potential methanol contamination risk found at the production site.

    Product
    Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. NDC: 74663-002-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0988-2023·2023-06-21

    Hu Vanilla Crunch Dark Chocolate recalled for undeclared tree nuts

    HU PRODUCTS is recalling Hu Vanilla Crunch Dark Chocolate bars nationwide because they may contain undeclared tree nuts, which pose a risk to consumers with tree-nut allergies.

    Product
    Hu Vanilla Crunch Dark Chocolate bar
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2023·2023-06-21

    Aspira Valve Repair Kit may fail to open and obstruct fluid drainage

    Merit Medical Systems is recalling Aspira Valve Repair Kits because valve assemblies may fail to open, preventing fluid drainage. The FDA Class II recall affects 2,559 units distributed across the US and internationally.

    Product
    Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1920-2023·2023-06-21

    Aspira Drainage Catheter Insertion Tray valve assembly may fail to open

    Merit Medical Systems is recalling certain Aspira Drainage Catheter Insertion Trays (Model 15.5F) due to a potential valve assembly defect that could prevent fluid drainage. No injuries have been reported.

    Product
    Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1918-2023·2023-06-21

    Aspira Drainage Catheter Tray Recalled for Potential Valve Malfunction

    Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly failure that may prevent fluid drainage. No injuries have been reported.

    Product
    Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2023·2023-06-21

    Aspira Pleural Drainage Catheter trays recalled for valve failure

    Merit Medical Systems recalls Aspira Pleural Drainage Catheter Insertion Trays because valve assemblies may not open, preventing fluid drainage. The recall affects 436 units distributed nationwide and internationally.

    Product
    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1908-2023·2023-06-21

    Aspira Peritoneal Drainage Catheter Insertion Tray Valve Malfunction Recall

    Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays due to a potential valve assembly malfunction that could prevent fluid drainage. No injuries have been reported.

    Product
    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1915-2023·2023-06-21

    Aspira Pleural Drainage Catheter Insertion Tray recalled due to valve failure

    Merit Medical Systems recalls the Aspira Pleural Drainage Catheter Insertion Tray due to a potential valve failure that could prevent fluid drainage. The recall affects approximately 1054 units distributed nationwide and internationally.

    Product
    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0986-2023·2023-06-21

    Texas Pete Buffalo Wing Sauce recalled for undeclared soy allergen

    T.W. Garner Food Co. is recalling Texas Pete Buffalo Wing Sauce due to undeclared soybean oil and soy lecithin. The product was distributed to 14 states.

    Product
    Texas Pete BUFFALO Wing Sauce 12 FL OZ - 355 mL TW GARNER FOOD CO. WINSTON-SALEM, NC 27105 UPC 0 75500 10011 6
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-1912-2023·2023-06-21

    Aspira Pleural Drainage Catheter Insertion Tray recalled for valve assembly malfunction

    Merit Medical Systems is recalling the Aspira Pleural Drainage Catheter Insertion Tray because valve assemblies may not open, preventing proper fluid drainage.

    Product
    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2023·2023-06-21

    bellavista 1000 Ventilator Recalled for Software Hang and Use Error Risk

    Vyaire Medical is recalling approximately 910 units of the bellavista 1000 Ventilator due to a software issue that can cause the touchscreen to become unresponsive and a potential use error risk if operators do not confirm settings are appropriate for the patient.

    Product
    bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2023·2023-06-21

    Prosthetic Socket Ratchet Locking Systems Recalled for Suspension Loss Risk

    Mechanical locking devices for prosthetic sockets may develop accelerated wear that causes the attachment pin to disengage, potentially leading to loss of prosthetic suspension and falls.

    Product
    Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1921-2023·2023-06-21

    Exeter V40 Trial Head 26mm -3 Color Mislabeling

    An orthopedic trial component may have incorrect color labeling. The Exeter V40 Trial Head (26mm, -3) may appear green when it should be blue. Two units distributed in Ireland.

    Product
    Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1970-2023·2023-06-21

    SteriPack Sterile Polyester Spun Swabs recalled due to breakage risk

    LumiraDx recalled 1,003 kits of SteriPack Sterile Polyester Spun Swabs due to failed post-sterilization testing. Swabs may break in the nasal cavity, potentially causing injury or requiring medical intervention to remove fragments.

    Product
    SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1968-2023·2023-06-21

    Tearaway Introducer Kit Recalled Due to Potential Connector Defect

    Galt Medical Corporation is recalling Tearaway Introducer Kits due to potential cracking or dislodging of the luer connection during use, which can render the device unusable and require replacement.

    Product
    Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2023·2023-06-21

    Philips Tempus LS-Manual Defibrillator pacing failure due to communication error

    A communication failure in the Philips Tempus LS-Manual Defibrillator may prevent pacing delivery. The device displays an error message and potentially becomes ineffective, affecting approximately 1,147 units distributed nationwide.

    Product
    Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2023·2023-06-21

    Driver Instrument May Break During Surgery, Leaving Metal Fragments

    The Superion Indirect Decompression System's driver instrument may fracture during implantation if excessive force is applied, potentially leaving metal fragments in the surgical site. Retained fragments contraindicate MRI scans.

    Product
    Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2023·2023-06-21

    External Fixation System Post Component Recall Due to Thread Stripping

    New Standard Device Inc is recalling 222 units of 'n'-Hole Posts used in the Revolution External Fixation System because the threads strip out during tensioning, potentially compromising fracture fixation.

    Product
    'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0876-2023·2023-06-21

    Prescription Drug Recall: Extended Phenytoin Sodium Dissolution Failure

    Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium capsules (Lot HL00721A, Exp. 12/2023) due to failed dissolution specifications. The extended-release mechanism did not function properly, which could affect medication absorption.

    Product
    EXTENDED PHENYTOIN SODIUM — EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Food)·F-0987-2023·2023-06-21

    Tillamook Ice Cream Recalled for Undeclared Wheat and Soy Allergens

    Tillamook Chocolate Peanut Butter ice cream cartons were mislabeled and contain Waffle Cone Swirl ice cream with undeclared wheat and soy allergens. The affected cartons were distributed in Idaho and Washington.

    Product
    Recalled product has the carton labeled as Tillamook 1.5 QT CHOCOLATE PEANUT BUTTER Ice Cream, frozen, 1.5 Qt. and has the correct lid labeled as Tillamook WAFFLE CONE SWIRL ICE CREAM. The carton label is read Tillamook CHOCOLATE PEANUT BUTTER ICE CREAM, KEEP FROZEN ***allergen
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1911-2023·2023-06-21

    Merit Medical Peritoneal Drainage Catheter Insertion Tray Recalled for Valve Failure

    Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays because valve assemblies may fail to open, potentially preventing proper fluid drainage in affected lots.

    Product
    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2023·2023-06-21

    Eye and Ear Dropper Recalled for Potential Glass Particulate Contamination

    Apothecary Products is recalling Eye and Ear Droppers (Product Code 67082) due to the potential for glass particulate on the dropper bulb's external surface. Consumers should stop using affected units immediately.

    Product
    Eye and Ear Dropper, Product Code 67082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1693-2023·2023-06-21

    p-Chip Wand Reader Recalled for Laser Classification Safety Issue

    FDA is recalling 329 p-Chip Wand Reader units due to laser operation potentially exceeding its classified safety level. Affected models are WA-4000, WA-4500, WA-8000, and WA-8500 distributed nationwide.

    Product
    p-Chip Wand Reader
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2023·2023-06-21

    Aspira Drainage Catheter Insertion Tray May Have Non-Opening Valve

    Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly malfunction that could prevent fluid drainage.

    Product
    Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2023·2023-06-21

    Tearaway Introducer Set Recall Due to Potential Luer Connection Failure

    Galt Medical Corporation is recalling Tearaway Introducer Sets due to potential cracks or dislodgement of the luer connection during use. The defect, linked to improper storage conditions, could render the device unusable.

    Product
    Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1919-2023·2023-06-21

    Aspira Drainage Catheter Insertion Tray recalled due to valve malfunction

    Merit Medical Systems is recalling Aspira Drainage Catheter Insertion Tray 15.5F due to potential valve assembly failure that may prevent fluid drainage. No injuries reported.

    Product
    Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·23V435000·2023-06-21

    2023 Airstream Bambi Recalled for Incorrect Cargo Capacity Labels

    Airstream is recalling certain 2023 Bambi travel trailers due to an overstated freshwater tank capacity that resulted in an incorrect cargo carrying capacity label. The mislabel could lead to unintentional overloading and increased crash risk.

    Product
    AIRSTREAM — AIRSTREAM BAMBI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1907-2023·2023-06-21

    Cardiosave Hybrid IABP Recall: Incorrect Compliance Annotation in Instructions

    The Cardiosave Hybrid Intra-Aortic Balloon Pump software update version D.00 includes instructions with incorrect annotations about compliance to standard 60601-1-12:2014. Four units were distributed in Germany.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0871-2023·2023-06-21

    Tranexamic Acid Tablets Recalled for Failed Manufacturing Specifications

    Amring Pharmaceuticals is recalling 48,989 bottles of Lysteda (tranexamic acid) USP 650 mg tablets due to failed manufacturing specifications for impurities and degradation. The affected lots did not meet conductivity specifications during quality testing.

    Product
    TRANEXAMIC ACID — TRANEXAMIC ACID (TRANEXAMIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0875-2023·2023-06-21

    Tranexamic Acid tablets recalled due to failed specification testing

    AVKARE LLC is recalling Tranexamic Acid USP 650mg tablets nationwide due to failed quality control specifications for conductivity. No illnesses have been reported.

    Product
    TRANEXAMIC ACID — TRANEXAMIC ACID (TRANEXAMIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1973-2023·2023-06-21

    Total Knee Pack Medical Kits Recalled for Incorrect Expiration Date

    American Contract Systems is recalling 36 Total Knee Pack medical convenience kits distributed to Massachusetts due to an incorrect expiration date on the product labeling.

    Product
    Total Knee Pack, REF CETJ130, medical convenience kits
    Category
    Medical Device
    Distribution
    1 state
  • SevereUSDA FSIS·026-2023·2023-06-20

    BCI Foods Recalls Chicken Noodle Soup for Import Violation

    BCI Foods Inc. is recalling approximately 13,561 pounds of chicken noodle soup products that were not presented for FSIS import reinspection.

    Product
    BCI Foods Inc. Recalls Chicken Noodle Soup Products Produced Without Benefit of Import Reinspection
    Category
    Food
    Distribution
    4 states
  • SevereUSDA FSIS·025-2023·2023-06-20

    USDA Recalls Ineligible Imported Ready-to-Eat Pork Rind Product

    Distribuidora El Paisano Import is recalling 1,715 pounds of TorTrix Con Chicharrón pork rinds imported from Guatemala, a country ineligible to export meat to the U.S.

    Product
    Distribuidora El Paisano Import, LLC, Recalls Ineligible Ready-To-Eat Pork Rind Product Imported from Guatemala
    Category
    Food
    Distribution
    4 states
  • HighNHTSA·23V434000·2023-06-19

    2023 Tesla Model 3 and Model Y Battery Disconnect Defect Recall

    Tesla is recalling 26 Model 3 and Model Y vehicles from 2023 because the pyrotechnic battery disconnect may fail to isolate the high-voltage battery after a crash, creating a risk of electrical shock.

    Product
    TESLA — TESLA MODEL Y, MODEL 3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V433000·2023-06-16

    Altec Recalls L and LR Series Aerial Devices for Hydraulic Hose Defect

    Altec is recalling 1999-2022 L and LR Series aerial devices because a hydraulic hose may fail, causing the platform or load to move unexpectedly.

    Product
    ALTEC — ALTEC LR SERIES AERIAL DEVICE, L SERIES AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·024-2023·2023-06-16

    Conagra Recalls Frozen Beef Shepherd's Pie Due to Plastic Contamination

    Conagra Brands is recalling approximately 2,717 pounds of frozen Marie Callender's Beef Shepherd's Pie due to possible contamination with clear, flexible plastic.

    Product
    Conagra Brands (Conagra Foods Packaged Foods, LLC) — Conagra Brands, Inc., Recalls Frozen Beef Shepherd’s Pie Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·23V430000·2023-06-15

    2023 Honda Civic recalled for brake modulator fluid leak

    Honda recalls 2023 Civic vehicles with a defective brake modulator that may leak fluid, potentially causing unintended vehicle movement or increased brake pedal travel.

    Product
    HONDA — HONDA, ACURA ACCORD, INTEGRA, RDX, CIVIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V428000·2023-06-15

    2023 Grand Design Momentum Toy Hauler Recall: Incorrect Cargo Capacity Label

    Grand Design RV is recalling certain 2023 Momentum toy haulers due to an incorrect Cargo Carrying Capacity label. The mislabeled weight information can lead to vehicle overload, increasing crash risk.

    Product
    GRAND DESIGN — GRAND DESIGN MOMENTUM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V431000·2023-06-15

    Honda Odyssey, Pilot, Passport Rearview Camera Display Failure Recall

    A faulty MOST cable connector in certain 2018-2023 Honda Odyssey, Pilot, and Passport vehicles may prevent the rearview camera image from displaying, reducing rear visibility and increasing crash risk.

    Product
    HONDA — HONDA PASSPORT, ODYSSEY, PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V432000·2023-06-15

    2023 Toyota Camry and Camry Hybrid: Loose Wheel Lug Nuts Risk Detachment

    Toyota is recalling 298 2023 Camry and Camry Hybrid vehicles because lug nuts attaching wheels may be loose, risking wheel detachment and loss of vehicle control. Owners are advised not to drive until dealers repair the issue.

    Product
    TOYOTA — TOYOTA CAMRY, CAMRY HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23222·2023-06-15

    Oceanic SCUBA Buoyancy Compensating Devices Recalled for Drowning Hazard

    Huish Outdoors is recalling Oceanic brand SCUBA diving buoyancy compensating devices because the weight pocket handle can break during use, preventing divers from dumping weight in an emergency to surface safely. No injuries have been reported, but 73 broken handles have been documented.

    Product
    SCUBA Diving Buoyancy Compensating Devices OceanPro, Excursion, Hera
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23223·2023-06-15

    Trek Bicycles with Promax Hydraulic Disc Brakes Recalled for Crash Hazard

    Trek Bicycle Corp. is recalling about 96,900 bicycles equipped with Promax hydraulic disc brakes because the brake hose can detach from the brake lever, posing a crash hazard. Trek has received 195 reports of this issue with no injuries reported.

    Product
    Promax hydraulic disc brakes sold on Trek bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·023-2023·2023-06-15

    Johnsonville Recalls Beddar With Cheddar Pork Sausage Links Due to Plastic Fibers

    Johnsonville is recalling approximately 42,062 pounds of Beddar with Cheddar pork sausage links due to possible contamination with thin black plastic fibers.

    Product
    Johnsonville, LLC — Johnsonville, LLC, Recalls Beddar With Cheddar Ready-to-Eat Pork Sausage Links Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1650-2023·2023-06-14

    Philips Trilogy and LifeVent ventilator models recalled for flow sensor debris

    Environmental debris accumulation may block flow sensors in Philips ventilators, potentially preventing accurate pressure and flow delivery to patients.

    Product
    Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0983-2023·2023-06-14

    Cookies Recalled for Undeclared Soy and Wheat Allergens

    TETAS Mireya, SABOR Galleta Oreo cookies are being recalled due to undeclared soy and wheat allergens. Consumers with soy or wheat allergies should not consume this product.

    Product
    TETAS Mireya, SABOR Galleta Oreo
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0976-2023·2023-06-14

    Tastykake Chocolate Kandy Kakes recalled for undeclared peanuts

    Tastykake Chocolate Kandy Kakes are being recalled due to undeclared peanuts. The product poses a serious risk to individuals with peanut allergies.

    Product
    Tastykake Chocolate Kandy Kakes NET WT 8 OZ (227g) 6-1.3 OZ (38g) PKGS TASTY BAKING COMPANY, PHILADELPHIA, PA 19112 UPC 0 25600 00225 4
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Devices)·Z-1666-2023·2023-06-14

    StealthStation Cranial Software displays inaccurate navigation during brain surgery

    A software anomaly in Medtronic's StealthStation Cranial Software may cause inaccurate surgical navigation during brain procedures. This can result in unintended tissue damage and prolonged surgery.

    Product
    StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
    Category
    Medical Device
    Distribution
    1 state
  • SevereNHTSA·23V427000·2023-06-14

    Great Dane Recalls 2024 Trailers Due to Tire Pressure Loss Risk

    Great Dane is recalling 2024 Champion and Everest trailers because tire pressure may drop at speeds over 45 mph, increasing crash risk.

    Product
    GREAT DANE — GREAT DANE EVEREST, CHAMPION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1630-2023·2023-06-14

    StealthStation Cranial Software Depth Gauge Synchronization Failure Risk

    A software anomaly in StealthStation Cranial Software causes depth gauge displays to lose synchronization during cranial biopsy procedures, risking inaccurate surgical guidance and tissue injury.

    Product
    StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1652-2023·2023-06-14

    Trilogy Evo Universal Ventilator Class I Recall—22,237 Units Affected

    The FDA has issued a Class I recall for the Trilogy Evo Universal Ventilator Model DS2000X11B, affecting 22,237 units distributed nationwide and globally. The device is manufactured by Philips Respironics, Inc.

    Product
    Trilogy Evo Universal Ventilator, Model Number DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0977-2023·2023-06-14

    Onion Powder Premium Recalled for Potential Salmonella Contamination

    Olam Food Ingredients is recalling Onion Powder Premium sold in bulk fiber bags due to potential Salmonella contamination. Affected product was distributed to Canada, Arkansas, and Illinois.

    Product
    Onion Powder Premium, 44.9 and 50 lb. fiber bags sold as bulk ingredient
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0980-2023·2023-06-14

    TETAS Mireya candy recalled for undeclared soy and walnut allergens

    DIBE LLC is recalling TETAS Mireya candy due to undeclared soy and walnut allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    TETAS Mireya, SABOR Ferrero
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0974-2023·2023-06-14

    Dark Chocolate Almonds Recalled Due to Undeclared Milk Allergen

    Meijer Inc is recalling Frederik's by Meijer Dark Chocolate Almonds due to undeclared milk. The product was distributed to Meijer stores in six Midwest states.

    Product
    Frederik's by Meijer Dark Chocolate Almonds, 12oz stand-up pouch, UPC 7-08820-68730-1
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1633-2023·2023-06-14

    FDA Recalls Walnut Wearable Smart Thermometer Due to Reported Skin Burns

    BearCare's Walnut Wearable Smart Thermometer (Model WT20) is being recalled due to reports of skin burns in children ages 0-6. The device was distributed nationwide; 1818 units were affected.

    Product
    Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1649-2023·2023-06-14

    Philips Respironics Ventilators Recalled for Flow Sensor Debris Accumulation

    Philips Respironics recalled approximately 57,395 ventilators due to environmental debris potentially accumulating on the flow sensor, which may prevent accurate delivery of pressure and volume to patients, risking hypoxemia.

    Product
    Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0979-2023·2023-06-14

    TETAS Mireya Galleta Maria Cookies Recalled for Undeclared Soy and Wheat

    DIBE LLC is recalling TETAS Mireya SABOR Galleta Maria cookies due to undeclared soy and wheat allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    TETAS Mireya, SABOR Galleta Maria
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0975-2023·2023-06-14

    Food Recall: Meijer Express Dark Chocolate Covered Almonds Due to Undeclared Milk

    Meijer Inc is recalling Meijer Express Dark Chocolate Covered Almonds due to undeclared milk, a serious risk for consumers with milk allergies. The recall affects 9,030 units in Michigan, Indiana, Illinois, Ohio, Kentucky, and Wisconsin.

    Product
    Meijer Express Dark Chocolate Covered Almonds, 7.5oz plastic cup with lid, UPC 7-60236-19787-4
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1651-2023·2023-06-14

    Trilogy Evo O2 EV300 respiratory devices recalled for debris accumulation

    Philips Respironics recalled 18,855 Trilogy Evo O2 EV300 devices because environmental debris may accumulate on the flow sensor, potentially causing inaccurate delivery of pressure or flow. This could result in patient hypoxemia if not promptly addressed.

    Product
    Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1692-2023·2023-06-14

    Surgical Procedure Packs Recalled Due to Included Light Handle Covers

    DeRoyal Industries is recalling two models of custom surgical procedure packs because they contain light handle covers that were previously recalled by another manufacturer. The packs were distributed in Virginia.

    Product
    Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1685-2023·2023-06-14

    AVNS ambIT System infusion kits recalled for missing air filter

    Avanos Medical is recalling certain AVNS ambIT System infusion kits because some units may lack the required air in-line filter. Affected kits were distributed worldwide including the US (Texas and Oregon) and Australia.

    Product
    AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2023·2023-06-14

    AVNS ambIT Catheter System Kits Recalled for Missing Air Filter

    Avanos Medical recalls some AVNS ambIT System catheter kits that were potentially distributed without an air in-line filter. Affected units were distributed worldwide, including in Texas, Oregon, and Australia.

    Product
    AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0865-2023·2023-06-14

    Empower Pharmacy Ascorbic Acid Injection Mislabeled as Preserved

    Empower Pharmacy is recalling Ascorbic Acid 500 mg/mL injection solution because vials labeled as preserved are actually preservative-free. The 504 affected vials were distributed nationwide.

    Product
    ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0972-2023·2023-06-14

    Blueberry Yogurt Parfaits Recalled for Undeclared Soy and Brown Sugar

    Sodexo Operations recalls simply to go Blueberry Yogurt Parfaits due to undeclared soy lecithin and brown sugar syrup. Consumers allergic to soy should not consume the product.

    Product
    simply to go Blueberry Yogurt Parfaits, 8.53oz, UPC 477088156552 and 477088150550; packaged in plastic cups
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0997-2023·2023-06-14

    Chili Cacahuate Japones Snacks Recalled for Undeclared Peanut

    Werner Gourmet Meat Snacks recalls Chili Cacahuate Japones snacks due to undeclared peanut allergen. The product poses a serious risk to consumers with peanut allergies.

    Product
    Chili Cacahuate Japones, net weight 5 oz (127g), packaged in a soft teal colored plastic pouch with the UPC code 7 09972 80082 2. There are 6 pouches per case. Werner Gourmet Meat Snacks Inc. Tillamook, OR 97141. The label declares: INGREDIENTS: CHILI, RICE FLOUR, WHEAT FLOUR
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-0981-2023·2023-06-14

    Chocolate spread recalled for undeclared soy allergen

    DIBE LLC is recalling TETAS Mireya, SABOR Nutella chocolate spread due to undeclared soy allergen. Consumers with soy allergies should not consume this product.

    Product
    TETAS Mireya, SABOR Nutella
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1683-2023·2023-06-14

    QIAstat-Dx Respiratory SARS-CoV-2 Test Kit Recalled for False Result Risk

    Qiagen Sciences LLC recalls 347 QIAstat-Dx Respiratory SARS-CoV-2 test kits due to faulty cartridges that could produce false results. Affected kits were distributed nationwide in nine states.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1698-2023·2023-06-14

    Magic3 Go Female Intermittent Urinary Catheters Recalled for Packaging Defect

    C.R. Bard Inc is recalling Magic3 Go female intermittent urinary catheters worldwide due to a manufacturing defect where the resealing label can separate from the product pouch, potentially compromising product sterility.

    Product
    Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0996-2023·2023-06-14

    Nature's Energy Children's Chewable Colostrum Recalled for Undeclared Milk Allergen

    Nature's Energy is recalling Children's Chewable Colostrum Orange Creamsicle (180 count) due to undeclared milk allergen on the label. Consumers with milk allergies could experience serious allergic reactions.

    Product
    Nature's Energy Children's Chewable Colostrum Orange Creamsicle, 180 count, UPC 804879183969 GTIN 860008676993
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1680-2023·2023-06-14

    DePuy Mitek surgical anchor inserter may fracture during use

    DePuy Mitek BIOKNOTLESS Rapid surgical anchor inserters may fracture during use, potentially retaining fragments in patients. Removal during surgery may cause bone damage and extended surgical time.

    Product
    DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0973-2023·2023-06-14

    Frozen Brat Roll Dough Recalled for Undeclared Egg Allergen

    Gonnella Frozen Products is recalling 949 cases of frozen brat roll dough due to undeclared egg. Egg was not disclosed on the product label.

    Product
    Brat Roll Frozen Dough Product Code 18429 UPC: 00078296184292. Individual unit wt 2.50 oz. Packaged in a cardboard box. 180 pieces per case.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1676-2023·2023-06-14

    Diagnostic Test Recall: 4Kscore Test Software Anomalies May Produce Erroneous Results

    BioReference Health is recalling the 4Kscore Test system due to software anomalies in its processing module that may generate erroneous diagnostic results. The recall affects 662 patient test results distributed in New Jersey.

    Product
    The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1677-2023·2023-06-14

    Surgical Anchor Inserter Tip Fragmentation During Patient Procedures

    DePuy Mitek's BIOKNOTLESS Plus anchor inserter may fragment during surgical use if bending force is applied. Fragments retained in the patient may require surgical removal, potentially causing bone damage.

    Product
    DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1681-2023·2023-06-14

    Surgical anchor inserter recalled for potential tip fracture and bone damage

    DePuy Mitek BIOKNOTLESS Rapid anchor inserters may fracture during use, potentially leaving fragments in the patient. If detected during surgery, removal could cause bone damage.

    Product
    DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0971-2023·2023-06-14

    Strawberry Yogurt Parfaits Recalled for Undeclared Soy Lecithin

    Sodexo is recalling simply to go Strawberry Yogurt Parfaits due to undeclared soy lecithin and brown sugar syrup. Consumers with soy allergies may be at risk.

    Product
    simply to go Strawberry Yogurt Parfaits, 8.53oz, UPC 477088125794; packaged in plastic cups
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1675-2023·2023-06-14

    Elekta Unity Image-Guided Radiation Therapy System Electrical Connector Overheating Risk

    Elekta, Inc. is recalling 18 Elekta Unity Image-Guided Radiation Therapy Systems due to a potential electrical connector overheat hazard in the MR gradient coil. No injuries have been reported.

    Product
    Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0994-2023·2023-06-14

    Children's colostrum supplement recalled due to undeclared milk allergen

    Nature's Energy Children's Chewable Colostrum Berry supplement is recalled because the label does not declare milk allergen, despite containing bovine colostrum. The recall affects consumers with milk allergies.

    Product
    Nature's Energy Children's Chewable Colostrum Berry, 180 count, UPC 804879183945 GTIN 860008676979
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1700-2023·2023-06-14

    Magic3 Go Pediatric Intermittent Urinary Catheters Recalled for Packaging Defect

    C.R. Bard Inc is recalling Magic3 Go pediatric intermittent urinary catheters due to a manufacturing defect where the resealing label can separate from the foil pouch, potentially compromising product sterility.

    Product
    Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1678-2023·2023-06-14

    DePuy Mitek BIOKNOTLESS Plus Anchor Inserter Tip May Fracture During Surgery

    DePuy Mitek BIOKNOTLESS Plus anchor inserter tips may break and be retained in patients during surgery. Removal of fragments could cause bone damage and prolong surgery time.

    Product
    DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0867-2023·2023-06-14

    Eye Drops Recalled: Travoprost Missing Tamper Evidence Seal

    Golden State Medical Supply is recalling Travoprost eye drops due to missing tamper evidence seals on some bottles. The missing seal prevents sterility assurance on 1,920 units distributed nationwide.

    Product
    TRAVOPROST — TRAVOPROST (TRAVOPROST)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1699-2023·2023-06-14

    Magic3 Go Intermittent Urinary Catheters Recalled for Packaging Defect

    C.R. Bard is recalling Magic3 Go Intermittent Urinary Catheters because the clear resealing label can separate from the pouch, potentially compromising sterility. The recall affects devices distributed worldwide.

    Product
    Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1688-2023·2023-06-14

    Avanos Recalls ambIT Cassette Filters for Missing Air In-Line Filter

    Avanos Medical is recalling ambIT Cassette Filter Male Luer (Product Code 220266) because some units were potentially distributed without an air in-line filter component.

    Product
    ambIT Cassette Filter Male Luer, Product Code: 220266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1687-2023·2023-06-14

    Avanos Medical Recalls ambIT Reusable Cassettes Missing Air-Inline Filter

    Avanos Medical is recalling SMMT ambIT Reusable cassettes (Product Code 220568, Lot 30191805) that were potentially distributed without a required air-in-line filter. The missing component affects units in Texas, Oregon, and Australia.

    Product
    SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1682-2023·2023-06-14

    BD Veritor System Instructions for Use Not FDA Approved

    The Instructions for Use for BD Veritor System rapid diagnostic tests for COVID-19 and flu were not FDA-approved, lacking proper specimen type specifications. Using the test with invalid specimen types could produce false positive or negative results, potentially delaying diagnosis or treatment.

    Product
    BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0866-2023·2023-06-14

    Levsin injection recalled for manufacturing quality program discontinuation

    Viatris Inc. is recalling Levsin injection (hyoscyamine sulfate, 0.5 mg/ml) due to discontinuation of the quality assurance program that verifies product identity, strength, quality, and purity. The recall affects 2,736 boxes distributed to 10 distributors.

    Product
    Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1691-2023·2023-06-14

    Sterile Surgical Procedure Packs Recalled for Defective Light Handle Covers

    DeRoyal Industries is recalling 2,972 sterile surgical procedure packs containing light handle covers that have been recalled by another manufacturer. The affected packs were distributed to hospitals in Virginia.

    Product
    Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Va
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2023·2023-06-14

    Presource Laparoscopy Kit Recalled for Lack of Sterility Assurance

    Cardinal Health is recalling Presource Kit laparoscopy surgical packs due to being released without sterility assurance. Affected units may harbor contamination and pose a risk during surgical procedures.

    Product
    Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
    Category
    Medical Device
    Distribution
    1 state

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