The Recall Desk

Archive

October 2022 recalls

446 recalls were announced in October 2022.

What the numbers show

Critical
9
Severe
95
High
273
Moderate
64
Low
5

Of the 446 recalls this month scored against our rubric, 2% are Critical, 21% are Severe.

301–400 of 446

  • SevereNHTSA·22V759000·2022-10-11

    FCA Recalls 2019-2020 Ram 4500 and 5500 for Brake Hose Defect

    FCA US is recalling 2019-2020 Ram 4500 and 5500 Cab Chassis vehicles because rear brake hoses may rupture, causing loss of braking ability.

    Product
    RAM — RAM 4500, 5500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V760000·2022-10-11

    Kia K5 Transmission Malfunction May Cause Complete Loss of Drive Power

    Kia is recalling certain 2021-2023 K5 and 2021-2022 Sorento vehicles with transmission oil pump malfunction that may cause complete loss of drive power, increasing crash risk.

    Product
    KIA — KIA K5, SORENTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V761000·2022-10-11

    Alamo Recalls 2021-2022 Schwarze A9SE Monsoon Street Sweepers

    Alamo Group is recalling 2021-2022 Schwarze A9SE Monsoon street sweepers because the hydraulic lift system may continue rising after disengagement, posing an injury risk.

    Product
    SCHWARZE — SCHWARZE A9SE MONSOON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22E086000·2022-10-11

    Chrysler Recalls Mopar Brake Hoses Due to Rupture Risk

    Chrysler is recalling specific Mopar brake hoses because the inside diameter may be too small, causing rupture and loss of braking ability.

    Product
    SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V758000·2022-10-10

    Wabash National Recalls 2020-2023 RFALHSA Trailers for Visibility Defect

    Wabash National is recalling 2020-2023 RFALHSA trailers because the lift gate obscures rear conspicuity tape, reducing visibility and increasing crash risk.

    Product
    WABASH NATIONAL — WABASH NATIONAL RFALHSA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V757000·2022-10-10

    Fontaine Recalls 2020-2023 Elgin Sweepers Due to Air Line Defect

    Fontaine is recalling 56 Elgin sweepers because a braided air line may rub through an oil tube, causing pump failure and loss of power.

    Product
    ELGIN SWEEPER — ELGIN SWEEPER CROSSWIND 1 (PB 220)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V755000·2022-10-08

    Riverside Recalls 2023 Travel Trailers Due to Awning Seam Defect

    Riverside RV is recalling 2023 Retro, Intrepid, and Xplorer travel trailers because a welded seam on the electric awning may separate, posing an injury risk.

    Product
    RIVERSIDE — RIVERSIDE XPLORER, INTREPID, RETRO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V753000·2022-10-07

    Volkswagen Atlas Engine Bearing Defect Recall 2022 through 2023

    Volkswagen is recalling 2022 and 2023 Atlas and Cross Sport vehicles because engine connecting rod bearings may become damaged, causing engine failure and stalling. This increases crash and fire risk.

    Product
    AUDI — AUDI, VOLKSWAGEN Q5 SPORTBACK, Q5, ATLAS CROSS SPORT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V748000·2022-10-07

    2023 Newmar Dutch Star Motorhome Brake Pedal Contact May Cause Brake Failure

    Newmar is recalling certain 2023 Dutch Star motorhomes because the brake pedal may contact the dash panel, causing unintended brake engagement. This can lead to brake failure and increase crash risk.

    Product
    NEWMAR — NEWMAR DUTCH STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V752000·2022-10-07

    2022 BMW motorcycles recalled for improperly lubricated clutch cover bolts

    BMW is recalling certain 2022 and 2023 motorcycles with improperly lubricated clutch cover bolts that may loosen and cause oil leaks, increasing crash and fire risks. Free bolt replacement is available through BMW dealers.

    Product
    BMW — BMW M 1000 RR, S 1000 RR, S 1000 R, S 1000 XR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V750000·2022-10-07

    Forest River Recalls 2023 Prime Time Avenger Travel Trailers

    Forest River is recalling 2023 Prime Time Avenger AVT32BHS travel trailers because improperly installed brackets may cause rear bunks to fail, risking occupant injury.

    Product
    FOREST RIVER — FOREST RIVER AVENGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V749000·2022-10-07

    Newmar Recalls 2020-2023 Super Star Motorhomes for Incorrect Tire Labeling

    Newmar is recalling 2020-2023 Super Star motorhomes because the Federal Certification label may list incorrect rear tire sizes, potentially leading to improper tire installation.

    Product
    NEWMAR — NEWMAR SUPER STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V744000·2022-10-06

    2022 Rivian R1T steering knuckle fastener loose, increasing crash risk

    Rivian is recalling 2022 R1T, R1S, and EDV vehicles due to front steering knuckle fasteners that may be improperly tightened. A loose fastener could separate, causing loss of vehicle control and crash risk.

    Product
    RIVIAN — RIVIAN R1T, EDV, R1S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23701·2022-10-06

    MillerKnoll Eames Desk and Storage Units Recalled for Lead Paint Violation

    MillerKnoll is recalling about 700 Eames Desk and Storage Units sold between October 2020 and March 2022 because the tan side panels contain lead paint levels exceeding the federal ban, posing a lead poisoning hazard to young children.

    Product
    Eames Desk Units and Eames Storage Units
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23002·2022-10-06

    Hearth & Hand Tea Kettles Recalled for Fire and Burn Hazards

    Target is recalling about 12,800 Hearth & Hand with Magnolia Tea Kettles due to paint chipping that poses a fire hazard, and handle and spout defects that risk burn injuries. No injuries have been reported.

    Product
    Hearth & Hand™ with Magnolia Tea Kettles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23004·2022-10-06

    Katadyn North America Recalls Optimus Gemini Portable Gas Stoves for Fire Hazard

    Katadyn North America is recalling about 1,100 Optimus Gemini portable 2-burner stoves because the gas regulator seal can tear, causing a gas leak and fire hazard. No injuries have been reported.

    Product
    Optimus Gemini portable 2-burner stoves
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23003·2022-10-06

    Swift Industries Recalls 9-Inch Rubber Straps for Bicycle Bags

    Swift Industries is recalling 9-inch rubber straps used to fasten bicycle bags because the straps can break, causing the bag to fall and creating a crash hazard to riders. No injuries have been reported.

    Product
    9-inch Swift Straps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1809-2022·2022-10-05

    Scottish Smoked Salmon Recalled Due to Listeria Monocytogenes Risk

    St. James Smokehouse is recalling Scottish Smoked Salmon due to possible Listeria monocytogenes contamination. The recall affects 11,141 four-ounce packs distributed domestically and internationally.

    Product
    St. James Smokehouse, Scotch Reserve, Scottish Smoked Salmon, Net Wt 4oz (114g)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1802-2022·2022-10-05

    Keswick Creamery Recalls Bovre Cheese for Potential Listeria Contamination

    Keswick Creamery is recalling Bovre cheese in multiple flavors due to potential Listeria monocytogenes contamination. The product was distributed to farm stores and farmers markets in Washington DC, Maryland, Virginia, and Pennsylvania.

    Product
    Bovre, multiple flavors: plain; oregano and garlic; herbes de Provence; cranberry and honey. 8oz clear deli container, expiration dates 7/25/22, 8/1/22, 8/8/22, 8/22/22
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1801-2022·2022-10-05

    Pasteurized Havarti cheese recalled for potential Listeria contamination

    Keswick Creamery is recalling Havarti cheese due to potential Listeria monocytogenes contamination. All products manufactured by the firm may be affected.

    Product
    Pasteurized milk cheese "Havarti" 4 oz to 12 oz packages
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·22V740000·2022-10-05

    Blue Bird Recalls 2022-2023 Vision Transit Buses Due to Fuel Leak Risk

    Blue Bird is recalling 2022-2023 Vision transit buses with 7.3L gasoline engines because a transmission cable may cause a fuel leak, increasing fire risk.

    Product
    BLUE BIRD — BLUE BIRD VISION TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1804-2022·2022-10-05

    Vermeer Cheese Products Recalled for Potential Listeria Contamination

    Keswick Creamery is recalling Vermeer Cheese due to potential Listeria monocytogenes contamination. Products were distributed to farm stores and farmers markets in Washington DC, Maryland, Virginia, and Pennsylvania.

    Product
    Vermeer Cheese in 4 oz to 12 oz packages
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1798-2022·2022-10-05

    Aged Raw Milk Cheese Recalled for Listeria Contamination Risk

    Keswick Creamery recalls Calverley aged raw milk cheese due to potential Listeria monocytogenes contamination affecting products distributed to farm stores and farmers markets in DC, MD, VA, and PA.

    Product
    Aged raw milk cheese "Calverley" 4 oz to 12 oz packages
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1800-2022·2022-10-05

    Whole Milk Ricotta Cheese Recall Due to Listeria Contamination Risk

    Keswick Creamery is recalling Whole Milk Ricotta cheese sold at farm stores and farmers markets in DC, MD, VA, and PA regions due to potential Listeria monocytogenes contamination.

    Product
    Pasteurized milk cheese "Whole Milk Ricotta" 8 oz and 16 oz clear deli container, expiration dates 7/18/22, 7/25/22, 8/1/22, 8/8/22, 8/18/22
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1795-2022·2022-10-05

    Aged raw milk cheese recalled for potential Listeria monocytogenes contamination

    Keswick Creamery is recalling Ploughman Cider Wash Tomme aged raw milk cheese (batch 47) due to potential Listeria monocytogenes contamination. The product was distributed to farm stores and farmers markets in Washington DC, MD, VA, and PA.

    Product
    Aged raw milk cheese "Ploughman Cider Wash Tomme" batch 47 4 oz to 12 oz packages
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1810-2022·2022-10-05

    Dutch Red Potatoes with Mustard Sauce Recalled for Undeclared Egg Allergen

    World Variety Produce is recalling Dutch Red Potatoes with Dijon Mustard Sauce because the sauce packet fails to declare the presence of egg, a common allergen. Consumers with egg allergies who consume the product risk allergic reactions.

    Product
    Dutch Red Potatoes with Dijon Mustard Sauce. NET WT. 1 LB 1.7 OZ (502g) UPC code 0-45255-15221-0 Distributed by World Variety Produce, Inc. Los Angeles, CA Product of USA.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1803-2022·2022-10-05

    Pasteurized Quark Cheese Recalled for Potential Listeria Contamination

    Keswick Creamery is recalling Pasteurized Quark cheese due to potential Listeria monocytogenes contamination. The cheese was distributed to farm stores and farmers markets in DC, Maryland, Virginia, and Pennsylvania.

    Product
    Pasteurized milk cheese "Quark", multiple flavors "Dill and Onion", and "Plain" 8 oz and 16 oz clear deli container, expiration dates 7/7/22, 8/4/22, 8/25/22
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1763-2022·2022-10-05

    TANDEM LIFE controller software failures affecting cardiopulmonary bypass equipment nationwide

    FDA recalls TANDEM LIFE LivaNova LIFESPARC Controllers due to critical software failures that cause the device to freeze, crash, or stop displaying data. The controllers are used in cardiopulmonary bypass procedures.

    Product
    TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1799-2022·2022-10-05

    Aged Raw Milk Feta Cheese Recalled for Listeria Risk

    Keswick Creamery is recalling aged raw milk feta cheese due to potential Listeria monocytogenes contamination. The product was distributed to farm stores and farmers markets in DC, Maryland, Virginia, and Pennsylvania.

    Product
    Aged raw milk cheese "Feta" in 4 oz to 12 oz packages
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1791-2022·2022-10-05

    Chocolate to Die For Premium Ice Cream recalled for undeclared peanuts

    Belfonte Ice Cream's Chocolate to Die For Premium Ice Cream may contain undeclared peanuts. Affected products were sold at Hy-Vee, Cash Saver, Harps, Price Mart, and Heartland in Kansas City, Tulsa, Columbia, and Springfield areas.

    Product
    1.5 quarts (1.41 L) Chocolate to Die For Premium Ice Cream UPC: 83057 17049 Plant Code 29-050
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1796-2022·2022-10-05

    Aged Raw Milk Cheese Recalled Due to Listeria Monocytogenes Risk

    Keswick Creamery at Carrock Farms LLC is recalling Vulkwin's Folly Scratch 2 aged raw milk cheese due to potential Listeria monocytogenes contamination. All products manufactured by the firm may be affected.

    Product
    Aged raw milk cheese "Vulkwin's Folly Scratch 2" 4oz-12oz packages
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0045-2023·2022-10-05

    Mother's Touch Complete Nutrition infant formula fails FDA conformance standards

    Mother's Touch Complete Nutrition for New Babies infant formula is being recalled because it does not conform to FDA safety standards for infant formula sold in the United States.

    Product
    Mother's Touch Complete Nutrition for New Babies Net WT. 13.8 OZ (391.6g) packaged in a white plastic circular container, 6 units per case
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1793-2022·2022-10-05

    Yellow Squash from Southeast Processing Recalled for Listeria monocytogenes

    Southeast Processing Ltd is recalling yellow squash sold in multiple forms due to positive detection of Listeria monocytogenes in product samples. The affected product was distributed to Georgia and South Carolina.

    Product
    Yellow Squash sold as Bulk, Diced, Half Moon Sliced, Julienne and Planks (Product codes 168-173)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1818-2022·2022-10-05

    Diagnostic imaging software may lose patient information edits during processing

    Ambra PACS and ProViewer versions 3.22.2.0 and 3.22.3.0 have a software defect where patient information edits may be lost during initial study processing due to a race condition between database systems.

    Product
    Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
    Category
    Medical Device
    Distribution
    43 states
  • HighNHTSA·22V741000·2022-10-05

    2023 BMW iX Transmission Defect Risk of Vehicle Rollaway

    BMW is recalling one 2023 iX with a defective transmission final drive gear weld that could break, causing vehicle rollaway if the parking brake is not engaged. Dealers will replace the electric drive unit at no cost.

    Product
    BMW — BMW IX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2022·2022-10-05

    FDA Recalls Cook Roadrunner PC Wire Guides for Packaging Sterility Breach

    Cook Incorporated is recalling Roadrunner PC Wire Guide devices due to a breach in packaging's chevron seal that may compromise sterility. Affected devices should not be used.

    Product
    Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1794-2022·2022-10-05

    Organic GreenWise Animal Crackers recalled for undeclared tree nut allergen

    Toufayan Bakery is recalling Organic GreenWise Animal Crackers due to undeclared coconut (tree nut) on the label. Consumers with tree nut allergies should not consume this product.

    Product
    Organic GreenWise Animal Crackers, NET WT 8 OZ (227 g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1854-2022·2022-10-05

    Barco Medical Network Adapter Recalled for Installation Issues

    Barco NV recalls 169 NexxisOR system network adapters (models K9303078A and K9303097A) due to installation issues. The affected devices were distributed in Florida, Illinois, and New Jersey.

    Product
    Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1545-2022·2022-10-05

    Inhalation Drug Recalled Due to Sterility Assurance Failure

    Cipla recalls Budesonide Inhalation Suspension ampules due to inability to assure sterility. Affected lots GA20080, GA20081, and GA20094 expire January 2024.

    Product
    BUDESONIDE — BUDESONIDE (BUDESONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1789-2022·2022-10-05

    Alida's Wheat Saoka Pita Bread recalled for undeclared soy allergen

    Alida's Wheat Saoka Pita Bread is recalled for undeclared soy lecithin found in the pan-grease canola oil. The product label does not disclose soy, posing a risk to soy-allergic consumers. Distributed in Washington state only.

    Product
    Alida's Wheat Saoka Pita Bread, 5 pieces per package. Net Wt. 16.25 oz. UPC 8 60004 65931 0. Product contains ingredients: Wheat Flour, White Flour, Water, Wheat Gluten, Yeast, Sorbitan monostearate, ascorbic acid, salt, Canola Oil. CONTAINS: Wheat, Gluten.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1807-2022·2022-10-05

    Frozen Organic Hash Browns Recalled for Listeria Contamination Risk

    Sprouts and True Goodness frozen organic hash browns are being recalled due to potential Listeria monocytogenes contamination. Products were distributed nationwide and internationally.

    Product
    Item SP204, Sprouts Organic Hash Browns Shredded Potatoes, 16 oz. bag, 12/16 oz. bags per case. Product contains Organic Potatoes and is frozen and it's not ready to eat and labeled with cooking instructions. Manufactured For Sprouts Farmers Market Phoenix, Arizona 85054. UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1829-2022·2022-10-05

    Cope Nitinol Guidewire Recalled Due to Packaging Sterility Breach

    Cook Incorporated is recalling Cope Mandril Wire Guide (Nitinol) devices because the packaging's chevron seal may be completely breached, potentially compromising sterility. The recall affects 1,501 US units and 380 international units.

    Product
    Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1805-2022·2022-10-05

    Alexia Organic Seasoned Hashed Browns recalled for potential Listeria contamination

    Lamb Weston Sales is recalling Alexia Organic Seasoned Hashed Browns Yukon Select Potatoes due to potential Listeria monocytogenes contamination. The frozen product was distributed nationwide and internationally.

    Product
    Item AX058, Alexia Organic Seasoned Hashed Browns Yukon Select Potatoes, 16 oz. bag, 12/16 oz. bags per case. Product is frozen and it's not ready to eat and labeled with cooking instructions. Produced by Lamb Weston, Kennewick, WA. UPC 8 34183 00303 5. Product contains Organ
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1788-2022·2022-10-05

    Alida's Saoka Pita Bread recalled for undeclared soy allergen

    Alida's Saoka Pita Bread contains undeclared soy lecithin from cooking oil, posing a risk to people with soy allergies. The product was distributed in Washington state.

    Product
    Alida's Saoka Pita Bread, 5 pieces per package. Net Wt. 16.25 oz. UPC 8 60004 65930 3. Product contains ingredients: White Flour, Water, Wheat Gluten, Yeast, Sorbitan monostearate, ascorbic acid, Salt, Canola Oil. CONTAINS: Wheat, Gluten.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1792-2022·2022-10-05

    A&W Root Beer Zero Sugar Recalled for Undeclared Sugar Content

    A&W Root Beer Zero Sugar in 20oz bottles is being recalled because it contains full sugar but is labeled as sugar-free. The affected product has lot number 071892 and was distributed in DC, MD, PA, and VA.

    Product
    "A&W Root Beer Zero Sugar" packaged in 20oz PET bottles. UPC: 00-0-78000-05340-1
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-1544-2022·2022-10-05

    Oxytocin injection recalled for incorrect sodium chloride concentration

    QuVa Pharma is recalling oxytocin injections due to incorrect formulation. Bags contain 0.45% sodium chloride instead of the intended 0.9%.

    Product
    oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1547-2022·2022-10-05

    Rifampin Capsules Recalled for Exceeding Impurity Specification Limits

    Akorn, Inc. is recalling 18,145 bottles of Rifampin Capsules, USP 150 mg due to impurity levels exceeding the FDA's 5 ppm interim specification limit for 1-Methyl-4-Nitrosopiperazine (MNP).

    Product
    Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1546-2022·2022-10-05

    Antidepressant Medication Recalled for Excessive Active Ingredient Potency

    Leading Pharma, LLC is recalling Clomipramine Hydrochloride Capsules (25mg) with Lot B14221 due to testing that found 110.6% of the labeled active ingredient strength. The medication was distributed nationwide.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1548-2022·2022-10-05

    Akorn Rifampin Capsules Recalled for Impurity Specification Failure

    Akorn is recalling Rifampin Capsules USP 300 mg (30-, 60-, and 100-count bottles) distributed nationwide because finished product exceeds the interim limit for 1-Methyl-4-Nitrosopiperazine impurity. The recall affects approximately 177,439 bottles.

    Product
    Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1835-2022·2022-10-05

    Cook Incorporated Recalls Guidewire Due to Packaging Seal Breach

    Cook Incorporated is recalling Heavy Double Flexible Tipped Wire Guide devices due to potential packaging seal breach that may compromise sterility. Affected products were distributed domestically and worldwide.

    Product
    Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2022·2022-10-05

    Vinyl Connecting Tubes Recalled Due to Packaging Seal Breach

    Cook Incorporated is recalling Vinyl Connecting Tubes because of a complete breach of the chevron seal in the packaging, which may compromise device sterility.

    Product
    Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2022·2022-10-05

    Bentson Plus Guidewire Recall for Compromised Packaging Sterility Seal

    Cook Incorporated is recalling Bentson Plus Wire Guides due to potential packaging seal breaches that may compromise device sterility. Affected devices may not maintain proper sterility before use.

    Product
    Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1840-2022·2022-10-05

    Cook Roadrunner PC Guidewire Recalled for Compromised Packaging Seal

    Cook Incorporated recalls Roadrunner PC Wire Guide devices due to a potential packaging seal breach that may compromise sterility. The recall affects 115 units distributed domestically and internationally.

    Product
    Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1842-2022·2022-10-05

    Cook Rosen Curved Wire Guide Recall: Sterility Concerns

    Cook Incorporated is recalling specific lots of Rosen Curved Wire Guide guidewires due to a complete breach of the packaging seal that may compromise device sterility. Affected devices were distributed nationwide in the US and worldwide.

    Product
    Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1832-2022·2022-10-05

    Cook Guidewire Products Recalled Due to Compromised Sterile Packaging

    Cook Incorporated is recalling Fixed Core Wire Guide products due to potential breach of sterile packaging seals. Affected devices may have compromised sterility.

    Product
    Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1823-2022·2022-10-05

    CooperSurgical incubator humidifier kit recall due to sterile barrier breach

    CooperSurgical is recalling 5,182 humidifier bottle and filter kits for BT37 Mark II incubators due to potential sterile barrier damage from packaging defects. This could result in use of unsterilized components, risking embryo contamination.

    Product
    Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1831-2022·2022-10-05

    Cook Medical Wire Guide Devices Recalled for Packaging Breach

    Cook Incorporated is recalling specific lots of Double Flexible Tipped Wire Guide Guidewire devices due to a complete breach of the packaging chevron seal, which may compromise sterility.

    Product
    Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DOC-21-40-0-2 G02431 C-TDOC-21-50-0-2 G05195 C-TDOC-25-50-0-2 G05145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1830-2022·2022-10-05

    Cope Mandril Wire Guide Guidewires Recalled for Packaging Seal Breach

    Cook Incorporated is recalling Cope Mandril Wire Guide stainless steel guidewires because the packaging chevron seal may be completely breached, compromising device sterility. Affected lots total 2,748 units in the US and 302 internationally.

    Product
    Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2022·2022-10-05

    Roadrunner PC Wire Guide Recalled for Packaging Breach and Sterility Compromise

    Cook Incorporated recalls Roadrunner PC Wire Guide devices due to packaging seal breaches that may compromise sterility. Devices were distributed nationwide and internationally.

    Product
    Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1827-2022·2022-10-05

    Bentson Wire Guide Recalled for Packaging Defect Affecting Sterility

    Cook Incorporated is recalling Bentson Wire Guide guidewires due to packaging seal failures that may compromise sterility. The recall affects over 5,500 units distributed in the U.S. and internationally.

    Product
    Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2022·2022-10-05

    Bentson Wire Guide Devices Recalled for Potential Sterility Compromise

    Cook Incorporated is recalling Bentson Wire Guide devices due to potential packaging defects that may compromise device sterility.

    Product
    Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2022·2022-10-05

    Olympus POWERSEAL Electrosurgical Device Recalled for Retention Ring Malfunction

    Olympus POWERSEAL electrosurgical devices are recalled for a component defect that may prevent the retention ring from securing the rotation knob, potentially delaying treatment.

    Product
    Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1845-2022·2022-10-05

    Cook Lunderquist Ring Torque Wire Guide packaging breach may compromise sterility

    Cook Incorporated is recalling Lunderquist Ring Torque Wire Guides due to a complete breach in the chevron seal of the packaging, which may compromise device sterility. The recall affects multiple lot numbers distributed nationwide and internationally.

    Product
    Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1828-2022·2022-10-05

    Coons Interventional Guidewire Recall Due to Packaging Sterility Breach

    Cook Incorporated is recalling Coons Interventional Wire Guide devices because the chevron seal on packaging may be completely breached, compromising sterility. 1,236 units were distributed.

    Product
    Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2022·2022-10-05

    Insulin Infusion Sets Recalled for Incorrect Dosing Information in Instructions

    Autosoft 90 insulin infusion sets are recalled because the instructions incorrectly state insulin fill values for two cannula sizes, potentially causing patients to receive fewer insulin units than intended.

    Product
    Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1790-2022·2022-10-05

    Alida's Samoon Pita Bread recalled for undeclared soy allergen

    Alida's Bakery is recalling Alida's Samoon Pita Bread because canola oil used in production contained undeclared soy lecithin. The recall affects 19 bags distributed in Washington state.

    Product
    Alida's Samoon Pita Bread, 4 pieces per package, net wt. 21 oz. UPC 8 60004 65933 4. Product contains ingredients: While Flour, Water, Wheat Gluten, Yeast, Sorbitan monostearate, ascorbic acid, Salt, Canola Oil. CONTAINS: Wheat, Gluten.
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·22V742000·2022-10-05

    Audi vehicles recalled for faulty rearview camera display software

    Certain 2021-2022 Audi vehicles may display a blank or black screen instead of the rearview camera image in reverse, reducing rear visibility and increasing crash risk. Dealers will update the infotainment software at no cost.

    Product
    AUDI — AUDI A5 CABRIOLET, SQ8, S5, E-TRON GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2022·2022-10-05

    Medline ClearPro Trach T-Piece Suction Catheter May Separate at Connector

    Medline is recalling 136,080 ClearPro Trach T-Piece Closed Suction Catheters because the suction catheter can come apart from the connector during patient suctioning.

    Product
    MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14; b. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1834-2022·2022-10-05

    Cook Guidewire Devices Recalled for Packaging Defect and Sterility Compromise

    Cook Incorporated is recalling fixed core wire guide devices due to packaging defects that may compromise device sterility. Approximately 5,669 units were distributed in the US and 5,286 internationally.

    Product
    Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 TSF-35-180 G00652 C-SF-18-40 G02255 TSF-25-145 G00617 TSF-32-145 G00638 C-SF-15-50 G02274 TSF-18-145 G00587 TSF-18-50 G00593
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2022·2022-10-05

    Leica Surgical Operating Microscopes recalled for illumination adjustment defect

    Leica Microsystems recalls 25 Leica Surgical Operating Microscopes (Part Number 10448999) due to a photodiode component change causing inaccurate illumination adjustment when BrightCare Plus with Luxmeter is used.

    Product
    Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1806-2022·2022-10-05

    Great Value Shredded Hash Browns Recalled for Listeria Contamination

    Great Value Shredded Hash Browns are recalled due to potential Listeria monocytogenes contamination. Consumers should not consume the product.

    Product
    Item GV020, Great Value Shredded Hash Browns, 4 lbs. bag, 6/4 lbs. bags per case. Product is frozen and it's not ready to eat. Distributed By: Walmart Inc. Bentonville, AR 72716. UPC 0 78742 15557 9. Product contains Potatoes, Disodium Dihydrogen Pyrophosphate, Dextrose.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2022·2022-10-05

    Olympus POWERSEAL surgical sealer recalled for loose retention ring defect

    Olympus Corporation is recalling certain POWERSEAL electrosurgical sealers due to an out-of-specification component that may allow the retention ring to loosen, potentially delaying surgical treatment.

    Product
    Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1543-2022·2022-10-05

    FDA Recalls Neoral Cyclosporine for Out-of-Specification Ethanol Content

    Novartis is recalling Neoral cyclosporine 25 mg capsules nationwide due to a manufacturing quality deviation. Lot APCD162 (expiration 01/2023) was found to have out-of-specification ethanol content during stability testing.

    Product
    NEORAL — NEORAL (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1833-2022·2022-10-05

    Cook Medical Guidewire Recall: Packaging Seal Breach May Compromise Sterility

    Cook Incorporated is recalling Fixed Core Wire Guide devices due to a potential breach in the packaging seal that may compromise device sterility.

    Product
    Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00466 THSCF-35-80-3 G04069 THSCF-35-180-15 G01151 TSCF-21-50-3 G00456 THSCF-35-145-3 G00412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1786-2022·2022-10-05

    Mobile X-Ray System Recalled for Software Calibration Error in Radiation Dose Meter

    Micro-X Rover mobile X-ray systems recalled due to a software calibration error that causes incorrect radiation dose readings. The malfunction may impede proper radiation exposure management decisions.

    Product
    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2022·2022-10-05

    Collagen Dental Wound Dressing Recalled Due to Potential Sterility Compromise

    Collagen Matrix Inc is recalling Collagen Dental Wound Dressing products because packaging may not be sealed, potentially compromising sterility. Affected products were distributed to medical distributors in six states.

    Product
    Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schuma
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1836-2022·2022-10-05

    Cook Newton Wire Guide Recalls Due to Potential Sterility Compromise

    Cook Incorporated is recalling certain Newton Wire Guide surgical guidewires because packaging seals may be breached, potentially compromising device sterility.

    Product
    Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2022·2022-10-05

    YelloPort Plus 5x70 Cannula recalled: labeled sterile but non-sterile

    YelloPort Plus 5x70 Cannula devices are labeled as sterile but are actually non-sterile. This mislabeling poses an infection risk for laparoscopic surgical patients.

    Product
    Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1811-2022·2022-10-05

    Insulin pumps recalled for software malfunctions affecting blood glucose control

    Tandem Diabetes Care is recalling 31,100 t:slim X2 insulin pumps due to software issues that could cause inaccurate insulin delivery, potentially leading to dangerous blood sugar levels. A software update is available to address the issues.

    Product
    t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1850-2022·2022-10-05

    Leica M530 Surgical Microscopes recalled for illumination adjustment defect

    Leica Microsystems is recalling 115 M530 surgical microscopes due to a photodiode component change that causes inaccurate illumination limit adjustment when using the BrightCare Plus feature with Luxmeter.

    Product
    Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1848-2022·2022-10-05

    Leica Surgical Operating Microscopes ARveo 8 recalled for illumination accuracy issue

    Leica Microsystems is recalling 30 ARveo 8 surgical microscopes (Part Number 10449063) distributed nationwide due to a photodiode component change causing inaccurate illumination adjustment when using the BrightCare Plus Luxmeter feature.

    Product
    Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2022·2022-10-05

    Olympus POWERSEAL 5MM Electrosurgical Sealer Recalled Due to Loose Retention Ring

    Olympus is recalling POWERSEAL 5MM electrosurgical sealers due to a component defect that may cause the rotation knob to loosen and delay surgical treatment.

    Product
    Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1785-2022·2022-10-05

    BD Pyxis MedBank Cabinet Software Update Prevents Drawer Access

    A software update for BD Pyxis MedBank medication dispensing cabinets contains an incompatible file that prevents Matrix drawers from opening, potentially delaying medication access in healthcare facilities.

    Product
    BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 . MedBank 200 Main operating with Windows 7 . MedBank 500 Main operating with Windows 7. An automated dispensing cabinet intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2022·2022-10-05

    Cook guidewires recalled for compromised sterility due to packaging breach

    Cook Incorporated is recalling Amplatz extra Stiff Wire Guides because packaging seals may be completely breached, potentially compromising device sterility.

    Product
    Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2022·2022-10-05

    Humidifier Bottle and Syringe Filter Kit Sterile Barrier Breach Recall

    CooperSurgical is recalling BT37 benchtop incubator humidifier and filter kits due to a potential sterile barrier breach. The defect may allow unsterilized devices to contaminate and degrade embryos during incubation.

    Product
    Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0742-2022·2022-10-05

    VIDAS CMV IgM diagnostic test kits recalled for invalid calibrations

    bioMerieux is recalling 480 VIDAS CMV IgM test kits with invalid calibrations distributed across 18 U.S. states. The calibration errors may affect diagnostic test accuracy.

    Product
    VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1761-2022·2022-10-05

    NanoSight particle analyzer recalled for laser safety non-compliance

    Malvern Panalytical is recalling approximately 111 NanoSight LM10 instruments with LM12 modules nationwide due to non-compliance with Class I laser safety requirements. Users may be exposed to unsafe laser radiation.

    Product
    NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1843-2022·2022-10-05

    Torq-Flex Wire Guide Guidewires Recalled Due to Packaging Seal Defect

    Cook Incorporated is recalling Torq-Flex Wire Guide guidewires because the packaging chevron seal may be breached, potentially compromising device sterility. The affected units were distributed domestically and internationally.

    Product
    Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1837-2022·2022-10-05

    Cook Roadrunner PC Guidewires Recalled for Compromised Packaging Sterility

    Cook Incorporated is recalling Roadrunner PC Hydrophilic Guidewires due to potential packaging seal breaches that may compromise device sterility. Affected devices were distributed in the United States and internationally.

    Product
    Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0 G175
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1852-2022·2022-10-05

    YelloPort Elite Laparoscopic Trocar and Adaptor Non-Sterile Recall

    Surgical Innovations Ltd is recalling YelloPort Elite laparoscopic surgical instruments because devices labeled as sterile are non-sterile, posing infection risk if used in surgery.

    Product
    Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1812-2022·2022-10-05

    t:slim X2 Insulin Pumps Recalled for Software Issues Affecting Blood Sugar Management

    Tandem Diabetes Care is recalling approximately 8,399 t:slim X2 insulin pumps due to software malfunctions that may affect blood sugar control. A software update is available to resolve the issues.

    Product
    t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1847-2022·2022-10-05

    Medical Guidewire Recalled for Packaging Defect Affecting Sterility

    Cook Incorporated is recalling Movable Core Wire Guide (Tefcor) guidewires due to a packaging defect where the chevron seal may be breached, potentially compromising device sterility.

    Product
    Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
    Category
    Medical Device
    Distribution
    Distributed nationwide

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