The Recall Desk

Archive

July 2024 recalls

547 recalls were announced in July 2024.

What the numbers show

Critical
9
Severe
88
High
398
Moderate
49
Low
3

Of the 547 recalls this month scored against our rubric, 2% are Critical, 16% are Severe.

301–400 of 547

  • ModerateFDA (Drugs)·D-0592-2024·2024-07-17

    Injectable Verapamil Hydrochloride Recalled Due to Cross Contamination Risk

    Zydus Pharmaceuticals is recalling Verapamil Hydrochloride Injection vials nationwide due to potential cross contamination with other products.

    Product
    VERAPAMIL HYDROCHLORIDE — VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2296-2024·2024-07-17

    Knee Surgery Procedure Kit Recalled for Ethylene Oxide Residue

    American Contract Systems Inc recalled a knee surgery procedure kit (Catalog RGTK10K) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits on the cast padding component.

    Product
    TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0599-2024·2024-07-17

    Rising Pharma recalls Diflorasone Diacetate ointment for failed impurity specifications

    Rising Pharma is recalling 868 tubes of Diflorasone Diacetate ointment because impurity levels failed to meet safety specifications during stability testing. No illnesses have been reported.

    Product
    DIFLORASONE DIACETATE — DIFLORASONE DIACETATE (DIFLORASONE DIACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2275-2024·2024-07-17

    Knee Procedure Tray Recalled for Excess Sterilization Gas Residue

    American Contract Systems is recalling TOTAL KNEE procedure trays because sterilization gas residuals on the cast padding component exceed regulatory safety limits. No injuries have been reported.

    Product
    TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0589-2024·2024-07-17

    Suntegrity IMPECCABLE SKIN Sunscreen Foundation Recalled for Manufacturing Deviations

    Suntegrity IMPECCABLE SKIN sunscreen foundation is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 8,202 tubes distributed nationwide and internationally.

    Product
    IMPECCABLE SKIN - IVORY — IMPECCABLE SKIN - IVORY (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0591-2024·2024-07-17

    Blemfree Salicylic Acid Lotion Recalled for Manufacturing Practice Deviations

    Equibal Inc. is recalling Blemfree All Day Lotion due to manufacturing deviations from Current Good Manufacturing Practices. The product was distributed nationwide via internet sales.

    Product
    BLEMFREE — BLEMFREE (SALICYLIC ACIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0596-2024·2024-07-17

    Micafungin for Injection Recalled for Cross Contamination Risk

    Zydus Pharmaceuticals recalls Micafungin for injection (Lot L300217) distributed nationwide due to potential cross contamination with other products. No illnesses have been reported.

    Product
    Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0593-2024·2024-07-17

    FDA recalls Verapamil Hydrochloride injectable due to cross contamination

    FDA is recalling 8,020 vials of Verapamil Hydrochloride Injection (Lot L300269) distributed nationwide due to potential cross contamination with other products.

    Product
    VERAPAMIL HYDROCHLORIDE — VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0595-2024·2024-07-17

    Micafungin injection vials recalled for cross-contamination

    Zydus Pharmaceuticals is recalling Micafungin for injection (100 mg/vial, Lot #L300220) due to potential cross-contamination with other products. Approximately 12,720 vials distributed nationwide in the USA and Puerto Rico are affected.

    Product
    Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2293-2024·2024-07-17

    Total Knee Procedure Kit Recalled for Excess Sterilization Residuals

    American Contract Systems Inc recalls the TOTAL KNEE Procedure Kit due to Ethylene Oxide and Ethylene Chlorohydrin residuals exceeding regulatory limits. No illnesses reported.

    Product
    TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V532000·2024-07-16

    Triple E RV Recalls Wonder Motorhomes Due to Generator Securing Defect

    Triple E Recreational Vehicles is recalling 2020-2024 Wonder motorhomes because the floor structure may be inadequately secured, allowing the generator to fall.

    Product
    TRIPLE E RV — TRIPLE E RV WONDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V533000·2024-07-16

    2024 Porsche Cayenne Front Suspension Control Arm May Crack and Fail

    Porsche is recalling 2,475 2024 Cayenne vehicles due to potentially cracked driver's side front upper control arms that may break and cause loss of steering control.

    Product
    PORSCHE — PORSCHE CAYENNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·022-2024·2024-07-15

    AW Farms Recalls Hot Dogs Produced Without Federal Inspection

    AW Farms is recalling approximately 6,900 pounds of ready-to-eat hot dogs produced without federal inspection. The products were distributed to restaurants and hotels in Ohio and West Virginia.

    Product
    AW Farms, LLC dba AW Meat House — AW Farms Recalls Ready-To-Eat Hot Dog Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    2 states
  • CriticalUSDA FSIS·021-2024·2024-07-13

    Taylor's Sausage Recalls Landjaeger Products for Undeclared Soy Allergen

    Taylor's Sausage is recalling approximately 74 pounds of ready-to-eat Landjaeger sausage due to misbranding and undeclared soy. The product was distributed in California and Oregon.

    Product
    Taylor's Sausage, Inc. — Taylor's Sausage, Inc. Recalls Ready-To-Eat Landjaeger Sausage Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·24V531000·2024-07-12

    2025 Forest River Cherokee Travel Trailers Recalled for Hitch Coupler Defect

    Forest River is recalling certain 2025 Cherokee travel trailers with incorrect trailer hitch couplers that may fail when overloaded, increasing the risk of crash or injury.

    Product
    FOREST RIVER — FOREST RIVER PUMA, CHEROKEE, WILDWOOD, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V530000·2024-07-12

    2024 Forest River travel trailers recalled for incorrect Federal Placard rim size

    Forest River is recalling 2024 Stealth EVO, Salem, and Wildwood travel trailers due to incorrect rim-size information on the Federal Placard. The mislabeling may result in wrong wheels being installed, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER SALEM, WILDWOOD, STEALTH EVO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24302·2024-07-11

    Best Lighting Products LED High Bay Light Fixtures Recalled for Fire Hazard

    Best Lighting Products is recalling approximately 710,600 LED High Bay Light Fixtures because plastic pins securing the LED board can degrade, allowing the energized board to come loose and pose a fire hazard. Three fires have been reported.

    Product
    LED High Bay Light Fixtures
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V529000·2024-07-11

    2024 Hyundai Santa Fe Transmission Control Software Error Causes Roll-Away Risk

    Hyundai is recalling 2024 Santa Fe vehicles due to a transmission control unit software error that may cause vehicles in PARK to roll away, increasing crash and injury risk. Hyundai will release an over-the-air software update and dealers will inspect and replace the transmission as needed.

    Product
    HYUNDAI — HYUNDAI SANTA FE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V527000·2024-07-11

    BMW Recalls Vehicles Due to Driver Air Bag Inflator Defect

    BMW is recalling specific 2013-2015 models because the driver's air bag inflator may explode during deployment, posing a risk of injury or death.

    Product
    BMW — BMW 328D, ACTIVE HYBRID 5, 535D, 528I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24300·2024-07-11

    Children's Lace Nightgowns Recalled for Burn Hazard

    Lovely Angel children's lace nightgowns sold on Temu.com violate federal flammability standards for sleepwear, posing a burn injury risk to children. About 4,360 units were sold between June 2023 and May 2024.

    Product
    Lovely Angel Children's Lace Nightgowns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V528000·2024-07-11

    Hyundai and Genesis fuel pump defect may cause loss of power

    Hyundai and Genesis are recalling 2019-2023 vehicles because the fuel pump may fail, causing loss of drive power and increasing crash risk. Dealers will update engine software and inspect/replace the fuel pump as needed.

    Product
    HYUNDAI — HYUNDAI, GENESIS VELOSTER N, G70, ELANTRA N, KONA N
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24299·2024-07-11

    Claire's and Icing Stores Halloween Witch Hats Burn Hazard Recall

    Claire's and Icing stores are recalling about 5,700 Halloween witch hats sold nationwide from July through December 2023. The hats violate federal flammability requirements and pose a risk of burn injuries.

    Product
    Halloween Witch Hats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24303·2024-07-11

    TonGass Pool Drain Covers Recalled for Entrapment Hazard

    TonGass 8-inch round pool drain covers do not meet Virginia Graeme Baker Pool and Spa Safety Act standards and pose an entrapment hazard to swimmers and bathers. About 1,650 units sold on Amazon from September 2023 through June 2024 are affected.

    Product
    TonGass pool drain covers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24298·2024-07-11

    Atomi Smart Heaters recalled for fire and burn hazards

    Atomi Smart Heaters can turn on without user input, creating fire and burn risks. About 99,400 units sold nationwide are affected; consumers should stop use immediately and follow refund instructions.

    Product
    Atomi Smart Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24301·2024-07-11

    Children's Pajama Sets Recalled for Burn Hazard and Flammability Violation

    JUVENNO KIDS is recalling about 18,620 children's button-up pajama sets sold on Temu.com because they violate federal flammability standards for sleepwear and pose a burn injury risk to children. No injuries have been reported.

    Product
    Children's Button-up Short-Sleeve/Shorts Two-Piece Pajama Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24296·2024-07-11

    Children's Pajama Sets Recalled for Flammability Hazard

    About 45,300 children's two-piece pajama sets sold on Temu.com violate federal flammability standards for sleepwear, posing a burn risk to children. Consumers should immediately stop using the garments and contact Fashion Online for a refund.

    Product
    Children's Long-Sleeve/Pants Two-Piece Pajama Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24297·2024-07-11

    Metal-framed Armchairs Recalled for Fall and Injury Hazards

    Ross Stores is recalling about 1,600 metal-framed armchairs because the chair legs can bend or break, posing fall and injury hazards. The company has received five reports of broken legs, four of which resulted in minor injuries.

    Product
    Metal-framed Armchairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0586-2024·2024-07-10

    Horny Goat Weed Capsules Recalled for Undeclared Sildenafil

    To the Moon Capsules are being recalled nationwide because they contain undeclared sildenafil, a prescription pharmaceutical. The product was marketed without FDA approval.

    Product
    To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2250-2024·2024-07-10

    Reusable Patient Return Electrode Recalled Due to Burn Risk

    MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrodes are recalled due to an identified risk of patient burns. Use should be restricted to patients aged 12 or older.

    Product
    Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0585-2024·2024-07-10

    RAM IT Horny Goat Weed Dietary Supplement Recalled for Undeclared Sildenafil

    Integrity Products recalls RAM IT Horny Goat Weed dietary supplement capsules nationwide because they contain undeclared sildenafil, a prescription drug not listed on the label.

    Product
    RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2249-2024·2024-07-10

    MEGADYNE MEGA SOFT Reusable Patient Return Electrode Recalled for Burn Risk

    Megadyne Medical recalls MEGA SOFT reusable patient return electrodes (Model 0830) due to identified burn risk. Use is restricted to patients aged 12 and older.

    Product
    Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1432-2024·2024-07-10

    Thyroid Supplement Recalled for Potential Salmonella Contamination

    Penn Herb Company is recalling Nature's Wonderland brand Thyroid Formula due to potential Salmonella contamination. Fifty-one bottles were distributed across nine states.

    Product
    Nature's Wonderland brand Thyroid Formula 60 Veg Capsules UPC: 715486893205. Packaged in White PET 150cc bottle with security closure
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2248-2024·2024-07-10

    Megadyne MEGA 2000 Patient Return Electrode recalled for burn risk

    Megadyne is recalling the MEGA 2000 Patient Return Electrode due to identified potential risk of patient burns. Use is now restricted to patients aged 12 or older.

    Product
    Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs. (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2226-2024·2024-07-10

    Medline Neuro IR Surgical Kit Recalled Due to Weak Seals

    Medline is recalling Neuro IR surgical convenience kits due to weak seals in the Pure Pouch component that may compromise sterility. The recall affects 12,588 kits distributed nationwide.

    Product
    Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-07102024-01·2024-07-10

    USDA Issues Public Health Alert for Illegally Imported Philippine Meat and Poultry

    USDA FSIS issued a public health alert for ready-to-eat meat and poultry products illegally imported from the Philippines. Consumers and retailers in nine states are urged not to consume or sell these items.

    Product
    FSIS Issues Public Health Alert for Ineligible Meat and Poultry Products Illegally Imported from the Philippines
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1456-2024·2024-07-10

    Lactose Powder Recalled Due to Potential Salmonella Contamination

    Grande Ingredients has recalled lactose and lactose powder products due to potential Salmonella contamination. No illnesses have been reported.

    Product
    Drug Emporium Yogurt Flavored Pretzels, 8oz (227g) , GNS Foods, Arlington, TX 76011
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2242-2024·2024-07-10

    ARTIS Angiography Systems Recalled for Potential Radiation Overdose

    Siemens ARTIS icono angiography systems with specific detector configurations may deliver higher radiation doses than intended in rare cases. The issue occurs during the first X-ray exposure after patient registration.

    Product
    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1471-2024·2024-07-10

    Ice Cream Recall: Foreign Rubber Found in Cookie Dough Product

    Casper's Ice Cream recalls Red Button Vintage Creamery Cookie Dough Ice Cream due to rubber pieces found in two tubs. The product was distributed across eight western states.

    Product
    Red Button Vintage Creamery Cookie Dough Ice Cream, Net weight 1.75 qt (1.66 L).
    Category
    Food
    Distribution
    8 states
  • HighFDA (Drugs)·D-0579-2024·2024-07-10

    Methylphenidate Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution

    Trigen Laboratories recalls Methylphenidate Hydrochloride Extended-Release Tablets (36mg) because a batch failed dissolution specifications. Approximately 10,448 bottles were distributed nationwide.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1462-2024·2024-07-10

    Breadman Brioche Products Recalled for Undeclared Yellow No. 5

    Breadbox Co. is recalling Breadman Brioche products (Toast, Buns, Sliders, Hot Dog) distributed in Southern California due to undeclared Yellow No. 5, which may affect consumers sensitive to this color additive.

    Product
    Breadman Brioche products in plastic bags: Brioche Toast, 2 lb. (1 loaf/bag), Brioche Buns, 40oz (10 buns/bag), Brioche Sliders, 50oz (25 sliders/bag), Brioche Hot Dog, 40oz (10 buns/bag)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2234-2024·2024-07-10

    Fathom Pedicle Retractor Blades Recalled for Manufacturing Defect

    SeaSpine Orthopedics recalls Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture or damage during surgery. 21 units were distributed nationwide.

    Product
    Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2261-2024·2024-07-10

    Stryker Corporation Recalls Expired Sterile Surgical Cannula Devices

    Stryker Corporation has recalled expired sterile cannula devices distributed nationwide. The devices were past their expiration date, potentially compromising sterility and device safety.

    Product
    This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2268-2024·2024-07-10

    Stryker Diagnostic Electrophysiology Catheters Recalled for Testing Failure

    Stryker Sustainability Solutions is recalling 6 units of BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters because they do not meet FDA testing requirements. The devices were distributed to Japan.

    Product
    Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2227-2024·2024-07-10

    Medline Birthing Room Pack surgical kits recalled due to weak sterile seals

    Medline is recalling approximately 12,588 sterile surgical kits used for childbirth procedures because weak seals on Pure Pouch components may fail and compromise sterility.

    Product
    Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Sharp/Blunt Scissors 5.5", Reorder #65945 and containing a Pure Pouch component Sterile 5.5" Episiotomy Scissors, Reorder #67645.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2264-2024·2024-07-10

    Immunoassay Analyzer Software Defect May Cause Incorrect Test Calibration

    Beckman Coulter is recalling 116 DxI 9000 Immunoassay Analyzers due to a software defect that fails to properly validate calibrator barcodes, potentially resulting in incorrect calibration curves and erroneous patient test results.

    Product
    DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2229-2024·2024-07-10

    Surgical Convenience Kits Recalled for Weak Seals Affecting Sterility

    Medline Industries recalls 7,673 surgical convenience kits due to weak Pure Pouch seals that may compromise sterility. Kits were distributed nationwide to healthcare facilities.

    Product
    Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2024·2024-07-10

    Acumatch L-Series Hip Implant Liners Recalled for Packaging Defect

    Exactech is recalling Acumatch L-Series hip implant liners because some units were packaged without the specified protective ethylene vinyl alcohol (EVOH) layer, which is required for proper device protection.

    Product
    Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2255-2024·2024-07-10

    BD Pyxis Medication Cabinets Recalled for Uncertified Power Strip Safety Risk

    BD Pyxis MEDBANK medication cabinets contain power strips not certified to electrical safety standards, potentially exposing users to leakage currents. The recall affects 677 units distributed nationwide.

    Product
    BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1HM-1FM/ 169-102, MEDBANK MINI 1HH-3HM/ 169-103, MEDBANK MINI 2FH/ 169-104, MEDBANK MINI 2FM/ 169-105, MEDBANK MINI 2HH-1FH/ 169-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2024·2024-07-10

    Siemens ARTIS Angiography Systems Recalled for Excessive Radiation Dose

    Siemens is recalling ARTIS angiography systems where the first X-ray after patient registration may use incorrect copper prefiltration, potentially resulting in higher radiation doses than intended.

    Product
    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1460-2024·2024-07-10

    Breadman Jalapeno Cheese Bagels Recalled for Undeclared Milk Allergen

    Breadbox Co. is recalling Breadman Jalapeno Cheese Bagels (16 oz, expiration 5/21/24) distributed in Southern California due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    Breadman Jalapeno Cheese Bagels, plastic bag, 16oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2265-2024·2024-07-10

    Abbott Liberta RC Pulse Generator Unexpectedly Shuts Down Periodically

    Abbott Liberta RC implantable pulse generators used for deep brain stimulation may unexpectedly turn off approximately every 50 days after activation, resulting in loss of therapy. Approximately 302 units have been recalled nationwide.

    Product
    Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2024·2024-07-10

    Surgical retractor blade manufacturing defect could cause bone fracture

    SeaSpine Orthopedics is recalling Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture. The recall affects 31 units distributed across nine US states.

    Product
    Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2024·2024-07-10

    X-ray cart positioning arm bolt may loosen and fall onto patient

    A bolt securing the positioning arm on First Source iQ Flex M X-ray carts may come loose and fall onto patients. The recall involves 137 units distributed across the US, Korea, and Serbia.

    Product
    First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2024·2024-07-10

    Beckman Coulter DxI 9000 Analyzer Tubing Malfunction Causes Test Errors

    Beckman Coulter DxI 9000 immunoassay analyzers may produce false or delayed test results due to pneumatic tubing disconnection during operation. Nine instruments are affected across the US and Europe.

    Product
    Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human bod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2024·2024-07-10

    Prucka 3 Amplifier capacitors could fail during cardiac monitoring procedures

    Capacitors in Prucka 3 Amplifiers used with CardioLab and ComboLab cardiac systems could fail, causing display oscillations and preventing visualization of heart electrical activity waveforms.

    Product
    Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spare part #5875569 (Assy CLABIII AMP 128CH 100-240V 50-60HZ).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2166-2024·2024-07-10

    HORIBA Fluorolog-QM Fluorescence Instrument Laser Safety Defect Recall

    HORIBA recalled 4 Fluorolog-QM fluorescence instruments due to a laser safety defect. A plastic cap instead of a proper beam stop may allow a Class 4 laser beam to exit the protective enclosure.

    Product
    HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2259-2024·2024-07-10

    Stryker Flyte Hood Protective Covers Recalled Due to Expired Products

    Stryker Corporation recalled Non-Sterile Flyte hood protective covers that were distributed expired. The affected medical device units may not function as intended.

    Product
    The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that the hood is securely tucked inside the gown. The hood attaches to and covers th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0583-2024·2024-07-10

    Allopurinol tablets recalled due to presence of foreign substance

    Dr. Reddy's Laboratories is recalling Allopurinol 300mg tablets due to the presence of a foreign substance. Approximately 20,520 units were distributed in Illinois, Mississippi, and Ohio.

    Product
    ALLOPURINOL — ALLOPURINOL (ALLOPURINOL)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-2266-2024·2024-07-10

    VITROS Chemistry FS Diluent Pack 3 Recalled for Negatively Biased Test Results

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry FS Diluent Pack 3, Lot 01-1645, because it may produce negatively biased results when used with CRP slides, potentially affecting patient diagnosis and care.

    Product
    VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0582-2024·2024-07-10

    Sun Pharmaceutical Recalls Decitabine Injection for Microbial Contamination

    Sun Pharmaceutical is recalling Decitabine for Injection (lot HAD2964A, 2,088 vials) for a Current Good Manufacturing Practice deviation. The Total Aerobic Microbial Count test on unfiltered bulk was out of specification; the product was distributed nationwide.

    Product
    Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1458-2024·2024-07-10

    Energique Mineral Magic Dietary Supplement recalled for yeast and mold contamination

    Grato Holdings is recalling Energique Mineral Magic Dietary Supplement because of potential yeast and mold contamination. Affected lot numbers G11602 (06/21), G11747 (07/22), and G11723 (08/22) were distributed in the US and Canada.

    Product
    Energique Mineral Magic Dietary Supplement, 2 fl. oz (59 ml) bottle.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1457-2024·2024-07-10

    Frozen Eggplant Parmesan Recalled for Undeclared Wheat and Milk

    Italiamo brand frozen Eggplant Parmesan may contain undeclared wheat and milk allergens. Foreign language labeling prevented proper allergen disclosure.

    Product
    Italiamo brand Melanzane alla Parmigiana pregratinate (Eggplant Parmesan) 450g UPC: 20456436. Frozen product. Packaged in plastic tray with paper sleeve, 12 units in every case.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Drugs)·D-0570-2024·2024-07-10

    Budesonide USP drug ingredient recalled for glass contamination

    Medisca Inc. is recalling 113 bottles of Budesonide, USP (Micronized) 500 mg due to glass particulate matter contamination caused by manufacturing deviations. The product was distributed nationwide in the USA and Canada.

    Product
    Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0574-2024·2024-07-10

    FDA recalls Dream Cream topical product due to manufacturing quality violations

    Little Moon Essentials voluntarily recalls Dream Cream due to manufacturing quality control violations. No illnesses reported.

    Product
    Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2024·2024-07-10

    BD Pyxis automated dispensing cabinets with noncertified power strips

    BD Pyxis automated dispensing cabinets were shipped with socket-outlet power strips that lack IEC electrical certification, potentially exposing users to leakage currents and electric shock.

    Product
    BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-4HH-2FM MP/ 169-145, BD PYXIS MB TWR MN 2FM-8HH-1FH MP/ 169-144, BD PYXIS MB TWR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2024·2024-07-10

    Siemens ARTIS Angiography Systems May Deliver Unintended Radiation Doses

    Siemens ARTIS icono angiography systems with certain detectors may deliver higher-than-intended radiation doses in rare cases. The issue occurs when incorrect copper prefiltration is applied during initial x-ray exposure after patient registration.

    Product
    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2228-2024·2024-07-10

    Medline Surgical Kits Recalled for Weak Seals Compromising Sterility

    Medline is recalling 12,588 sterile surgical kits with Pure Pouch components that have weak seals, potentially compromising sterility and exposing patients and surgical teams to non-sterile instruments.

    Product
    Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. b. Medline Cath Lab Pack, Pack #DYNJ56141A, containing a Pure Pouch containing component Medline D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2024·2024-07-10

    Medline surgical convenience kits recalled for weak seal integrity

    Medline surgical convenience kits containing Pure Pouch components with weak seals may fail to maintain sterility, potentially compromising the safety of contained medical instruments. Affected kits were distributed nationwide across 23 states.

    Product
    Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #DYNJ040408, Kelly Forceps/STD STR Sterile. b. Medline Adult/Child Intubation Kit, Pack #ACC010616 and Pack #ACC010616H, containing a P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2246-2024·2024-07-10

    Portable X-Ray Cart Positioning Arm Bolt May Come Loose and Fall

    First Source Inc is recalling the First Source Vision M portable X-ray cart because the bolt securing the positioning arm to the gas spring may come loose and fall onto a patient.

    Product
    First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2024·2024-07-10

    Nalu Neurostimulation Kits Recalled for Manufacturing Defect and Device Failure

    Nalu Medical recalls 13 neurostimulation and peripheral nerve stimulation kits due to a manufacturing defect that may prevent the implantable pulse generator from functioning, stopping pain signal inhibition.

    Product
    Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2024·2024-07-10

    BD Alaris System Manager Software Connectivity Issue Recalled Nationwide

    A software issue in BD Alaris System Manager version 12.5.1 may prevent the PC unit from connecting to the server, potentially affecting wireless data transmission. CareFusion 303, Inc. is recalling the affected software version nationwide.

    Product
    BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2267-2024·2024-07-10

    Prostate Treatment Balloons Recalled Due to Fill Volume Mislabeling

    Angiodynamics is recalling IsoLoc Prostate Immobilization Balloons (ISO-100, Lot 5402) for mislabeling. Devices have 100cc fill volume but are labeled as ISO-60 (60cc).

    Product
    IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2024·2024-07-10

    Medline Surgical Convenience Kits Recalled for Weak Seal Compromise

    Medline recalled 7,673 surgical convenience kits nationwide due to weak seals in the Pure Pouch component that may compromise sterility of surgical instruments. No injuries have been reported.

    Product
    Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2 Adult Kit, Pack ACC010365A, containing a Pure Pouch component DYNJ04048, Kelly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2231-2024·2024-07-10

    Medline surgical convenience kits recalled due to weak Pure Pouch seals

    Medline is recalling over 7,600 Open Heart surgical convenience kits nationwide due to weak seals on the Pure Pouch component. The seals may fail and compromise the sterility of the surgical instruments inside.

    Product
    Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2024·2024-07-10

    Medline surgical convenience kits recalled for weak seal defects

    Medline Industries is recalling 12,588 sterile surgical convenience kits due to weak seals on Pure Pouch components that may breach sterility. Products were distributed nationwide across 23 states.

    Product
    Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. b. Medline Angiography Pack, Pack #DYNJ26488W, containing a Pure Pouch with compo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2024·2024-07-10

    Zyno Medical Z800 Series Infusion Pumps: Faulty Power Supply May Prevent Battery Charging

    Certain Zyno Medical Z800 series infusion pumps contain faulty power supply modules that cannot charge the rechargeable battery. When unplugged from AC power, affected pumps may lack sufficient charge to operate.

    Product
    Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2238-2024·2024-07-10

    AMT Initial Placement Dilator Set Recalled Due to Incorrect Guidewire Labeling

    Applied Medical Technology is recalling 74 units of the AMT Initial Placement Dilator Set (Model IP-DIL) due to incorrect guidewire labeling. The labeling error could result in improper guidewire selection during gastrostomy placement procedures.

    Product
    AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2024·2024-07-10

    Sterile surgical kits recalled due to weak pouch seals risking contamination

    Medline sterile surgical kits are being recalled nationwide due to weak seals in the Pure Pouch component that may allow sterility breach. The recall affects 12,588 units distributed across 23 states.

    Product
    Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2024·2024-07-10

    Avalon Ultrasound Transducers Recalled for Inaccurate Fetal Heart Rate Monitoring

    Philips is recalling Avalon ultrasound transducers used for monitoring fetal heart rate. The device may produce inaccurate measurements when monitoring multiple fetuses, potentially delaying detection of fetal distress.

    Product
    Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2244-2024·2024-07-10

    MicroPort Knee Implant Recall: Wrong Size Component in Packaging

    MicroPort's EVOLUTION MP knee implants recalled due to one confirmed case where a Size 3 left-side component was packaged in a Size 4 right-side box. No injuries reported; distribution is limited to China with no U.S. inventory.

    Product
    EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0578-2024·2024-07-10

    Hand Sanitizer Recalled for Manufacturing Practice Violations

    Little Moon Essentials Clear Breeze Plus Hand Sanitizer is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed nationwide in the USA and Canada.

    Product
    Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC Code 6 73673 88798 0, NDC 70722-319-04; Little Moon Essentials LLC Dania Beach
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0575-2024·2024-07-10

    FDA Recalls Little Moon Essentials Vital Vapor Balm Due to Manufacturing Deviations

    Little Moon Essentials has voluntarily recalled Vital Vapor Balm (camphor 0.6%, menthol 5.2%) due to Current Good Manufacturing Practice deviations. The Class II recall affects 1,041 units distributed nationwide in the United States and Canada.

    Product
    Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6 73673 88231 2, NDC 70722-229-05) b) 2OZ (57G) glass jar, UPC Code 6 73673 88220 6, NDC 70722-229-02; c) 4OZ (113G) glass jar, UPC Code 6 73673 88218 3, NDC 7072
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1459-2024·2024-07-10

    Botanical Herbal Supplement Recalled for Potential Yeast and Mold Contamination

    Grato Holdings is recalling BioActive Nutritional MINAPLEX botanical herbal supplement due to potential yeast and mold contamination. The recall involves 261 bottles (lot J28761) distributed nationwide in the US and Canada.

    Product
    BioActive Nutritional MINAPLEX, Botanical Herbal Supplement; 1 Fl. oz. (30 ml) bottle.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0571-2024·2024-07-10

    Drug Recall: Little Moon Essentials Magical Muscle Oil due to CGMP Deviations

    Little Moon Essentials is recalling Magical Muscle Oil due to manufacturing practice deviations. The recall affects 1,654 glass jars distributed nationwide in the USA and Canada.

    Product
    Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88202 2, NDC 70722-246-02; b) 4 FL OZ (118ML) jar, UPC Code 6 73673 88233 6, NDC 70722-246-04; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2233-2024·2024-07-10

    Operating Room System Recalled for Incomplete Electrical Safety Testing Records

    Olympus has recalled 227 EasySuite 4K operating room systems worldwide due to incomplete documentation of earth leakage testing, which is required to confirm electrical current levels are within safety standards.

    Product
    EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, sur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2245-2024·2024-07-10

    Medical Device Calibrator Kit Assigned Extended Incorrect Expiration Date

    Ortho-Clinical Diagnostics is recalling a calibrator kit with an incorrect expiration date that could bias lab results if used past its true expiration date.

    Product
    VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent Mo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0584-2024·2024-07-10

    Venlafaxine Extended-Release Capsules Recalled for Failed Dissolution

    The FDA is recalling Venlafaxine Hydrochloride extended-release capsules (37.5mg) distributed nationwide because routine stability testing revealed the capsules failed to meet dissolution specifications, potentially affecting drug effectiveness.

    Product
    Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0576-2024·2024-07-10

    Drug Recall: Little Moon Essentials Ass Kisser due to CGMP Deviations

    Little Moon Essentials is voluntarily recalling Ass Kisser due to CGMP deviations identified in the manufacturing process. The recall affects 165 metal tins distributed nationwide in the USA and Canada.

    Product
    Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88228 2, NDC 70722-208-05; b) 3 OZ (85.05G) metal tin, UPC Code 6 73673 88208 4, NDC 70722-208-03; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0573-2024·2024-07-10

    Drug Recall: Little Moon Essentials Aching Head Rub for Manufacturing Defects

    Little Moon Essentials Aching Head Rub is being recalled by the manufacturer for manufacturing deviations. The voluntary recall affects 6,312 units distributed nationwide and in Ontario, Canada.

    Product
    Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0580-2024·2024-07-10

    Dodex Injectable Cyanocobalamin Recalled Due to Subpotent Drug Defect

    Accord Healthcare is recalling Dodex Injectable (Cyanocobalamin) due to subpotency; affected batches contain less active ingredient than labeled. Patients using affected lots should contact their healthcare provider.

    Product
    Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0572-2024·2024-07-10

    Topical Pain-Relief Product Recalled Due to Manufacturing Violations

    Little Moon Essentials Crampy Belly Rub, a camphor-based topical product, is being recalled nationwide and in Canada due to manufacturing deviations. The firm-initiated recall affects 788 glass jars.

    Product
    Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0577-2024·2024-07-10

    Little Moon Essentials Asana Kisser Drug Recalled Due to CGMP Deviations

    Little Moon Essentials Asana Kisser, a topical product containing camphor and menthol, is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 320 units distributed in the United States and Canada.

    Product
    Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-03; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2243-2024·2024-07-10

    WOM Tube Set for Irrigation Recalled Due to RFID Tag Data Error

    WOM Tube Set for Irrigation (1700 units, Lots 4030902 and 4030903) is recalled due to incorrect RFID tag data that causes an error message preventing use in endoscopic surgeries, potentially resulting in surgical delays.

    Product
    WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2260-2024·2024-07-10

    Stryker Curved Cement Delivery Needles Recalled: Expired Products Distributed

    Stryker recalled its Curved Cement Delivery Needle (Lot 6659783) due to expired product distribution. Three units were distributed to customers in Arkansas, California, Colorado, Florida, and Michigan.

    Product
    Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the ability to inject bone cement into multiple different areas through a single point o
    Category
    Medical Device
    Distribution
    Distributed nationwide

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