The Recall Desk

Archive

December 2023 recalls

600 recalls were announced in December 2023.

What the numbers show

Critical
29
Severe
213
High
307
Moderate
49
Low
2

Of the 600 recalls this month scored against our rubric, 5% are Critical, 36% are Severe.

1–100 of 600

  • SevereUSDA FSIS·065-2023·2023-12-31

    Valley Meats Recalls Ground Beef Products Due to E. Coli O157:H7 Contamination

    Valley Meats LLC is recalling approximately 6,768 pounds of raw ground beef products produced on December 22, 2023, due to possible E. coli O157:H7 contamination.

    Product
    Valley Meats LLC — Valley Meats, LLC, Recalls Ground Beef Products Due to Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V903000·2023-12-29

    2023–2024 INEOS Grenadier vehicles recalled for faulty steering fasteners

    Ineos Automotive Americas is recalling certain 2023–2024 Grenadier vehicles due to non-locking nuts that may have been installed on the steering rod ball joint, risking steering failure and loss of vehicle control.

    Product
    INEOS — INEOS GRENADIER QUARTERMASTER, GRENADIER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·24071·2023-12-28

    High-Powered Magnetic Balls Recalled Due to Ingestion Hazard

    A set of 5mm magnetic balls sold online through Walmart.com via Joybuy is being recalled because the magnets are too strong and can cause serious internal injuries or death if swallowed, especially by children.

    Product
    Relax 5mm Science Kit, Large Hematite Magnets Magnetic Stones Building Blocks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24070·2023-12-28

    Simpson Gas Pressure Washers Recalled for Lithium Battery Burn Hazard

    FNA Group is recalling about 2,930 Simpson Gas Pressure Washers with Electric Start because the lithium battery in the electric start system can overheat and pose a burn hazard. Two reports of battery overheating have been received, but no injuries have been reported.

    Product
    Simpson Gas Pressure Washers with Electric Start
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0624-2024·2023-12-27

    Cantaloupe chunks with Tajin recalled for potential Salmonella contamination

    Renaissance Food Group is recalling Cantaloupe Chunks with Tajin due to potential Salmonella contamination. The product was distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina.

    Product
    Cantaloupe Chunks with Tajin 9 OZ (255 g) UPC 8 26766 13935 4 Dist By Reniassence Food Group LLC 4322 Moreland Avenue Conley GA 30288
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0626-2024·2023-12-27

    FDA Recalls Large Fruit Trays for Salmonella Contamination

    Renaissance Food Group is recalling Large Fruit Trays (73 oz) distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina due to potential Salmonella contamination.

    Product
    Large Fruit Tray NET WT 73 OZ (4 LBS 9 OZ) 2.06 kg UPC 8 26766 19100 0 Dist. By: Renaissance Food Group, LLC Rancho Cordova, CA 95670
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0628-2024·2023-12-27

    Mixed Fruit Bowls Recalled Due to Salmonella Contamination

    Renaissance Food Group has recalled 67 units of 32 oz Mixed Fruit Bowls due to potential Salmonella contamination. The affected product was distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina.

    Product
    Mixed Fruit Bowl NET WT 32 oz (2 lbs) 907 g UPC 8 26766 13944 6 Dist. By: Renaissance Food Group, LLC 4322 Moreland Ave Conley, GA 30288
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0630-2024·2023-12-27

    Food Recall: Mixed Melon with Taijin for Salmonella Contamination

    Renaissance Food Group is recalling Mixed Melon with Taijin due to potential Salmonella contamination. The product was distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina.

    Product
    Mixed Melon with Taijin NET WT 9 OZ (255g) UPC 8 26766 13932 3, Dist. By Renaissance Food Group, LLC 4322 Moreland Ave Conley, GA 30288
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Devices)·Z-0513-2024·2023-12-27

    FDA Recalls Sterile Water and Saline Bottles for Sterility Assurance Issues

    Nurse Assist, LLC is recalling sterile water and saline bottles across multiple brands due to potential lack of sterility assurance. The products could be nonsterile and may cause infection.

    Product
    Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022, 100ML STERILE WATER BOTTLE/1024, 100ML STERILE WATER BOTTLE/10000, 100ML STERILE WATER BOTTLE/PT00103419, 100ML STERILE SALINE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0673-2024·2023-12-27

    Fruit Tray Recalled Due to Potential Salmonella Contamination

    TGD Cuts, LLC is recalling a packaged fruit tray due to potential Salmonella contamination. Affected products were distributed in PA, NJ, MD, WV, SC, VA, DE, NC, and NY.

    Product
    FRUIT TRAY 3/64 oz. Packaged in a tray. UPC: 840219166315
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-0622-2024·2023-12-27

    Frozen Salmon Burgers Recalled for Undeclared Sesame and Milk

    Raw Seafoods Inc. is recalling frozen, lightly seasoned salmon burgers nationwide due to undeclared sesame seeds and milk, which pose serious allergic reaction risk to sensitive consumers.

    Product
    Frozen, Lightly Seasoned Salmon Burgers, 28x6oz., 10.5 lbs cases
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0637-2024·2023-12-27

    Food Recall: Trader Joe's Cantaloupe Chunks Due to Salmonella Risk

    Trader Joe's Fresh Cut Fruit Cantaloupe Chunks are being recalled due to potential Salmonella contamination. The product was distributed in Alabama, Georgia, Florida, North Carolina, and South Carolina.

    Product
    Trader Joe's Fresh Cut Fruit Cantaloupe Chunks NET WT 16 OZ (1 LB) 453g UPC 0095 2668, DIST & SOLD EXCLUSIVELY BY TRADER JOE'S MONROVIA, CA 91016
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0677-2024·2023-12-27

    Melon Tri Color Chunks Recalled for Potential Salmonella Contamination

    TGD Cuts, LLC is recalling Melon Tri Color Chunks due to potential Salmonella contamination. The product was distributed across eight eastern states.

    Product
    MELON TRI COLOR CHUNKS 6/9 OZ Packaged in clamshell containers. UPC:840219192703
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0644-2024·2023-12-27

    HMC Farms Nectarines recalled due to Listeria monocytogenes contamination

    HMC Farms Nectarines in 2lb gusset bags are being recalled due to potential Listeria monocytogenes contamination. The product has been distributed across the United States and internationally.

    Product
    HMC Farms Nectarines 2lb Gusset Bag
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Devices)·Z-0537-2024·2023-12-27

    AirFit F20 Full Face Mask recalled for magnetic interference with medical implants

    ResMed is recalling AirFit F20 Full Face Masks due to magnets that can interfere with active medical implants. Updated warnings will guide safe distances for patients and those in close contact.

    Product
    AirFit F20 Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0643-2024·2023-12-27

    HMC Farms Peaches Recalled for Potential Listeria Contamination

    The HMC Group Marketing Inc is recalling HMC Farms Peaches 2lb Gusset Bag due to potential contamination with Listeria monocytogenes. The recalled peaches were distributed across 26 U.S. states and internationally.

    Product
    HMC Farms Peaches 2lb Gusset Bag
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-0681-2024·2023-12-27

    Mixed Fruit Burst Recalled for Potential Salmonella Contamination

    TGD Cuts, LLC is recalling Mixed Fruit Burst 6/10 oz packages due to potential Salmonella contamination. The recall affects products distributed across eight states with use-by dates from November 2–24, 2023.

    Product
    MIXED FRUIT BURST 6/10 OZ Packaged in clamshell containers. UPC: 840219168357
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0649-2024·2023-12-27

    HMC Farms Nectarines recalled for potential Listeria contamination

    HMC Farms Signature Farms Nectarines in 2lb bags are recalled due to potential Listeria monocytogenes contamination. The product was distributed across multiple U.S. states and to Mexico, Canada, and Taiwan.

    Product
    HMC Farms Nectarines Signature Farms 2lb bag
    Category
    Food
    Distribution
    27 states
  • SevereNHTSA·23V902000·2023-12-27

    2023-2024 Battle Motors LET2 trucks recalled for steering linkage failure

    Battle Motors is recalling certain 2023 and 2024 LET2 trucks because the drag link in the steering system may become deformed or break, potentially causing complete loss of steering control.

    Product
    BATTLE MOTORS — BATTLE MOTORS LET2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0633-2024·2023-12-27

    Sprouts Farmers Market Apple Fruit Medley recalled for Salmonella contamination

    Sprouts Farmers Market Apple Fruit Medley (10 oz and 20 oz) distributed in Alabama, Georgia, Florida, North Carolina, and South Carolina is recalled due to Salmonella contamination.

    Product
    Sprouts Farmers Market Apple Fruit Medley 10 OZ (283g) UPC 8 26766 40543 5 & 20 OZ (1.25 LB) 566g UPC 8 26766 40544 2 Manufactured Exclusively for Sprouts Farmers Market, Phoenix, Arizona 85054
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0540-2024·2023-12-27

    AirTouch N20 Nasal Mask recalled for magnetic interference with medical implants

    ResMed is recalling 424,309 units of AirTouch N20 Nasal Masks because they contain magnets that may interfere with active medical implants and ferromagnetic materials. Updated safety warnings are being provided.

    Product
    AirTouch N20 Nasal Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0514-2024·2023-12-27

    Sterile Water and Saline Products Recalled for Lack of Sterility Assurance

    Nurse Assist is recalling sterile water and saline irrigation products due to lack of sterility assurance. Use of nonsterile products could result in infection.

    Product
    Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0620-2024·2023-12-27

    Kwik Trip Mixed Fruit Recalled Due to Potential Salmonella Contamination

    Kwik Trip Mixed Fruit (Item 930847, 6 oz) is being recalled for potential Salmonella contamination. The recall affects products sold in IA, IL, MI, MN, SD, and WI with sell-by dates from November 4 to December 3, 2023.

    Product
    Kwik Trip Mixed Fruit, Item 930847. Net Wt 6 oz (170g). UPC 0 39779-00240 3. Produced & Distributed by Kwik Trip Inc., La Crosse WI
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0684-2024·2023-12-27

    Mixed Fruit Medley Recalled for Potential Salmonella Contamination

    TGD Cuts, LLC is recalling Mixed Fruit Medley products due to potential Salmonella contamination. The recall affects clamshell packages distributed across eight states.

    Product
    MIXED FRUIT MEDLEY 6/6 OZ, 4/16OZ. Packaged in clamshell containers. UPCs: 840219182445 and 840219124292
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0674-2024·2023-12-27

    Cantaloupe chunks and spears recalled for potential Salmonella contamination

    TGD Cuts, LLC is recalling cantaloupe chunks and spears due to potential Salmonella contamination. The products were distributed in Pennsylvania, New Jersey, Maryland, West Virginia, South Carolina, Virginia, Delaware, North Carolina, and New York.

    Product
    Cantaloupe Chunks/Spears: Cantaloupe Chunks 1" 50/2 oz. Packaged in film UPC: 840219184845 Cantaloupe Chunks 1" 2/5 lb. Packaged in trays. UPC: 840219184449 Cantaloupe Chunks 6/16oz. Packaged in clamshell containers. UPC: 840219150345 Cantaloupe Chunks 50/2 oz. Packaged in…
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-0536-2024·2023-12-27

    ResMed AirFit N10 Nasal Masks Recalled for Magnetic Interference with Medical Implants

    ResMed is recalling AirFit N10 Nasal Masks because magnets in the masks may interfere with active medical implants. Patients with such implants should consult their healthcare provider before using these masks.

    Product
    AirFit N10 Nasal Masks and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0153-2024·2023-12-27

    FDA Recalls Phenytoin Oral Suspension Due to Content Uniformity Failure

    The FDA recalled Phenytoin Oral Suspension from Major Pharmaceuticals due to failed content uniformity specifications affecting 3,718 units distributed nationwide.

    Product
    Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0623-2024·2023-12-27

    Cantaloupe Chunks Recalled Due to Potential Salmonella Contamination

    Renaissance Food Group recalls Cantaloupe Chunks (9oz and 18oz packages) distributed to AL, GA, FL, NC, and SC due to potential Salmonella contamination.

    Product
    Cantaloupe Chunks 9oz (255g) UPC 8 26766 13923 1 & 18 oz (1 LB 2 OZ) 5??g UPC 8 26766 13917 0 Dist By Renaissance Food Group, LLC 4322 Moreland Avenue, Conley, GA 30288
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0629-2024·2023-12-27

    Mixed Melon Products Recalled Due to Salmonella Contamination

    Renaissance Food Group is recalling mixed melon products in 9 oz and 18 oz packages due to potential Salmonella contamination. The affected products were distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina.

    Product
    Mixed Melon NET WT 9 OZ (255 g) UPC 8 26766 13926 2 & 18 OZ (1 LB 2 OZ) 510 g Dist. By: Renaissance Food Group LLC 4322 Moreland Ave Corley, GA 30288
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0541-2024·2023-12-27

    AirFit F30 Full Face Mask recalled for magnetic interference with medical implants

    ResMed is recalling the AirFit F30 Full Face Mask because the device contains magnets that can interfere with active medical implants and ferromagnetic objects. The original user guide did not adequately warn about safe distance requirements.

    Product
    AirFit F30 Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0151-2024·2023-12-27

    TING 2% Miconazole Nitrate Spray Recalled for Benzene Contamination

    Insight Pharmaceuticals recalls TING 2% Miconazole Nitrate Athlete's Foot Spray due to benzene contamination. The recall affects 117,336 cans distributed nationwide and in Puerto Rico.

    Product
    TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591, UPC 363736532611.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0634-2024·2023-12-27

    Food recall: Sprouts Fruit Spears for potential Salmonella contamination

    Renaissance Food Group has recalled Sprouts Farmers Market Assorted Fruit Spears due to potential Salmonella contamination. The product was distributed to customers in Alabama, Georgia, Florida, North Carolina, and South Carolina.

    Product
    Sprouts Farmers Market Assorted Fruit Spears NET WT 20 OZ (1.25 LB) 566g UPC 8 26766 40542 8
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0632-2024·2023-12-27

    Fruit Tray with Dip Recalled for Salmonella Risk Across Five States

    Renaissance Food Group is recalling Small Fruit Trays with Dip due to potential Salmonella contamination. The product was distributed to consumers in Alabama, Georgia, Florida, North Carolina, and South Carolina.

    Product
    Small Fruit Tray with Dip NET WT 26.75 OZ (1 LB 10.75 OZ) 758 g UPC 8 26766 19099 7 Dist By Renaissance Food Group, LLC 4322 Moreland Ave Conley, GA 30288
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0627-2024·2023-12-27

    Large Fruit Tray with Dip Recalled for Salmonella Contamination

    Renaissance Food Group is recalling Large Fruit Tray with Dip products distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina due to potential Salmonella contamination. Consumers who purchased affected products should not consume them.

    Product
    Large Fruit Tray with Dip NET WT 73.5 OZ (4 LBS (.5 OZ) 2.08 kg UPC 8 26766 19101 7 Dist. By: Renaissance Food Group LLC Rancho Cordova, CA 95670
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0685-2024·2023-12-27

    Mixed Fruit Melon Medley Chunk Recalled for Potential Salmonella Contamination

    TGD Cuts, LLC is recalling Mixed Fruit Melon Medley Chunk products due to potential Salmonella contamination. Affected products with use-by dates from November 2 to November 23, 2023 were distributed in eight states.

    Product
    MIXED FRUIT MELON MEDLEY CHUNK 4/32 OZ, 6/16 OZ. Packaged in clamshell containers. UPCs: 840219109954 and 840219109961
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0682-2024·2023-12-27

    Mixed Fruit Products Recalled for Potential Salmonella Contamination

    TGD Cuts, LLC is recalling various mixed fruit products distributed across eastern states due to potential Salmonella contamination.

    Product
    Mixed Fruit: Mixed Fruit Burst 6/10 oz. UPC: 840219168357 Packaged in clamshell containers Mixed Fruit Chunk 4/32 oz. UPC: 840219109947 Packaged in clamshell containers Mixed Fruit Chunk 4/6 oz. UPC: 840219198606 Packaged in clamshell containers Mixed Fruit Chunks 1" 20 lb.…
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0687-2024·2023-12-27

    Tropical Fruit Bowl recalled for potential Salmonella contamination

    TGD Cuts, LLC is recalling Tropical Fruit Bowl 4/24 oz packages due to potential Salmonella contamination. Affected products with use dates 11/2/2023 to 11/24/2023 were distributed in eight states.

    Product
    TROPICAL FRUIT BOWL 4/24 OZ Packaged in clamshell containers. UPC: 840219193786
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0159-2024·2023-12-27

    Blistex Tolnaftate antifungal spray powder recalled for benzene contamination

    Blistex Inc is recalling Odor-Eaters brand Tolnaftate 1% antifungal spray powder nationwide due to benzene contamination. The recall affects approximately 243,386 cases distributed in the USA, Canada, and Korea.

    Product
    BLISTEX — BLISTEX (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0631-2024·2023-12-27

    Small Fruit Trays Recalled Due to Salmonella Contamination

    Renaissance Food Group is recalling 71 small fruit trays due to Salmonella contamination. Affected products were distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina.

    Product
    Small Fruit Tray NET WT 1 LB 10 OZ (26 OZ) 737 g UPC 8 26766 19098 0
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0645-2024·2023-12-27

    HMC Farms Plums Recalled Due to Potential Listeria Contamination

    The HMC Group Marketing Inc is recalling HMC Farms Plums 2lb Gusset Bags (UPC 788814320858) due to potential contamination with Listeria monocytogenes. The product was distributed throughout the United States and internationally.

    Product
    HMC Farms Plums 2lb Gusset Bag
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-0686-2024·2023-12-27

    Mixed Fruit Spears Recalled for Potential Salmonella Contamination

    TGD Cuts, LLC is recalling Mixed Fruit Spears 6/16 OZ due to potential Salmonella contamination. The products were distributed across nine states including PA, NJ, MD, WV, SC, VA, DE, NC, and NY.

    Product
    MIXED FRUIT SPEARS 6/16 OZ. Packaged in clamshell containers. UPC:840219171579
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-0512-2024·2023-12-27

    Sodium Chloride IV Flush Kits Recalled for Potential Sterility Failure

    Nurse Assist recalls sodium chloride IV flush solutions due to potential loss of sterility assurance. Nonsterile solutions could cause infection when used for intravenous administration.

    Product
    0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0642-2024·2023-12-27

    Holiday Nogg Recall Due to Undeclared Egg Allergen

    United Dairy Farmers Holiday Nogg may contain undeclared egg allergen. Consumers with egg allergies should not consume the product and should contact the company for refund information.

    Product
    United Dairy Farmers - Holiday Nogg packaged in clear plastic HDPR 1/2 gallon jug. UPC: 076310050493
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0511-2024·2023-12-27

    IV Flush Syringes and Irrigation Solutions Recalled for Sterility Defect

    Nurse Assist, LLC recalls sodium chloride irrigation solutions and IV flush syringes due to potential lack of sterility assurance, which could allow contamination and infections.

    Product
    0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP; SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001; HALYARD OWENS MINOR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0646-2024·2023-12-27

    HMC Farms White Peaches recalled due to potential Listeria contamination

    HMC Farms White Peaches 2lb Gusset Bag are recalled due to potential Listeria monocytogenes contamination. The product was distributed across the United States and internationally.

    Product
    HMC Farms White Peaches 2lb Gusset Bag
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-0651-2024·2023-12-27

    HMC Farms Peaches Recalled for Potential Listeria Contamination

    HMC Farms Peaches in 4lb boxes are being recalled due to potential contamination with Listeria monocytogenes. The product was distributed to 26 U.S. states and three countries.

    Product
    HMC Farms Peaches 4lb box
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-0636-2024·2023-12-27

    Sprouts Tropical Fruit Blend recalled for possible Salmonella

    Renaissance Food Group voluntarily recalled Sprouts Tropical Fruit Blend due to potential Salmonella contamination. The product was distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina.

    Product
    Sprouts Tropical Fruit Blend NET WT 10 OZ (283g) UPC 8 26766 89490 1 Manutfactured Exclusively for Sprouts Farmers Market Phoenix, Arizona 90504
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0635-2024·2023-12-27

    FDA Class I recall of Sprouts Farmers Fruit Tray for Salmonella

    Renaissance Food Group initiated a recall of Sprouts Farmers Fruit Tray (32 oz) due to Salmonella contamination. The recall affects fruit trays distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina.

    Product
    Sprouts Farmers Fruit Tray NET WT 32 OZ (2 LB) 907g UPC 8 26766 89481 9
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0652-2024·2023-12-27

    HMC Farms White Nectarines Recalled for Potential Listeria Contamination

    HMC Farms White Nectarines 4lb boxes are being recalled due to potential contamination with Listeria monocytogenes. The product was distributed to 26 U.S. states and internationally.

    Product
    HMC Farms White Nectarines 4lb box
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Devices)·Z-0542-2024·2023-12-27

    AirFit F30i Full Face Mask Recalled Due to Magnetic Interference Risk

    ResMed is recalling the AirFit F30i Full Face Mask due to potential magnetic interference with active medical implants and ferromagnetic objects. Safety warnings are being updated.

    Product
    AirFit F30i Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0549-2024·2023-12-27

    Infusion pump recalled for mechanical valve interference interrupting therapy delivery

    Ivenix infusion pump may experience mechanical interference on fluid valve pins, interrupting therapy delivery. FDA recalled 938 units in five states due to potential risk of serious patient harm.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-0621-2024·2023-12-27

    Kwik Trip Mixed Fruit Tray Recalled for Potential Salmonella Contamination

    Kwik Trip Mixed Fruit Tray is recalled for potential Salmonella contamination. Approximately 77,013 units were distributed in six states with sell-by dates from Nov. 4 to Dec. 3, 2023.

    Product
    Kwik Trip Mixed Fruit Tray, Item 930941. Net Wt 16 oz (1 lb.) 454g. UPC 0 39779-00248 4. Produced & Distributed by Kwik Trip Inc., La Crosse WI
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0158-2024·2023-12-27

    Male Enhancement Capsules Recalled for Containing Unapproved Drug Ingredient

    THE ROCK male enhancement capsules are recalled because they contain Sildenafil, a pharmaceutical ingredient not approved for this product. The product was distributed in Florida, the Bahamas, and Turks & Caicos Islands.

    Product
    THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0679-2024·2023-12-27

    Mixed Fruit Luau Bowl recalled for potential Salmonella contamination

    TGD Cuts, LLC is recalling Mix Fruit Luau Bowl products due to potential Salmonella contamination. Affected units were distributed in eight states with use-by dates from November 2-23, 2023.

    Product
    MIX FRUIT LUAU BOWL 3/56 OZ Packaged in clamshell containers. UPC: 840219171753
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0680-2024·2023-12-27

    Mixed Fruit Products Recalled Due to Potential Salmonella Contamination

    TGD Cuts, LLC is recalling Mixed Fruit products in multiple package sizes due to potential Salmonella contamination. The affected products were distributed in nine states.

    Product
    Mixed Fruit: Mixed Fruit 20 lb. UPC: 840219153148. Packaged in buckets Mixed Fruit 5 lb. UPC: 840219116273. Packaged in trays Mixed Fruit 2/5 lb. UPC: 840219153247. Packaged in trays Mixed Fruit 3/40 oz. UPC: 840219175898. Packaged in trays
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0678-2024·2023-12-27

    MIX FRUIT ALOHA BOWL recalled for potential Salmonella contamination

    TGD Cuts, LLC is recalling MIX FRUIT ALOHA BOWL due to potential Salmonella contamination. Affected products were distributed in PA, NJ, MD, WV, SC, VA, DE, NC, and NY.

    Product
    MIX FRUIT ALOHA BOWL 3/48 OZ Packaged in clamshell container. UPC:840219170299
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0608-2024·2023-12-27

    Dark Chocolate Coins Recalled for Undeclared Milk Allergen

    Manischewitz Magic Max's Dark Chocolate Coins are recalled due to undeclared milk from mispackaging. The product was distributed to retailers in multiple states and may affect consumers with milk allergies.

    Product
    Manischewitz Magic Max's Dark Chocolate Coins, NET WT. 0.53 OZ (15g), UPC: 072700200387 Display Box UPC: 072700200356, 12 bags per case. Product packaged in gold foil in blue netting bags.
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-0641-2024·2023-12-27

    Aviator Dehydrated Tomato Halves Recalled for Undeclared Sulfites

    Aviator Dehydrated Tomato Halves are recalled due to undeclared sulfites. Sulfites are allergens that can trigger reactions in sensitive individuals.

    Product
    Aviator Dehydrated Tomato Halves, Net Wt. 4x2.27kg (5lbs)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0647-2024·2023-12-27

    HMC Farms White Nectarines recalled due to potential Listeria contamination

    HMC Farms White Nectarines 2lb Gusset Bags are recalled due to potential contamination with Listeria monocytogenes. The affected product was distributed across the United States and internationally.

    Product
    HMC Farms White Nectarines 2lb Gusset Bag
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-0638-2024·2023-12-27

    Trader Joe's Fresh Cut Fruit Fruitful Medley recalled for Salmonella

    Renaissance Food Group recalls Trader Joe's Fresh Cut Fruit Fruitful Medley due to potential Salmonella contamination. The product was distributed to customers in Alabama, Georgia, Florida, North Carolina, and South Carolina.

    Product
    TRADER JOE'S FRESH CUT FRUIT FRUITFUL MEDLEY NET WT 16 OZ (1 LB) 453g UPC 0054 9912 DIST & SOLD EXCLUSIVELY BY TRADER JOE'S MONROVIA, CA 95013
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0648-2024·2023-12-27

    HMC Farms Peaches Recalled Due to Listeria Contamination Risk

    HMC Farms Peaches Signature Farms 2lb bags have been recalled due to potential Listeria monocytogenes contamination. The affected product was distributed widely across the United States and internationally.

    Product
    HMC Farms Peaches Signature Farms 2lb bag
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-0683-2024·2023-12-27

    Mixed Fruit Cube Recalled for Potential Salmonella Contamination

    TGD Cuts, LLC is recalling Mixed Fruit Cube 1/2" products due to potential Salmonella contamination. The recall affects units distributed in Pennsylvania, New Jersey, Maryland, West Virginia, South Carolina, Virginia, Delaware, North Carolina, and New York.

    Product
    MIXED FRUIT CUBE 1/2"-NO GRA 20 LBS. Packaged in buckets. UPC: 840219191096
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0676-2024·2023-12-27

    Melon Loupe/Dew Chunks Recalled for Potential Salmonella Contamination

    TGD Cuts, LLC is recalling Melon Loupe/Dew Chunks packaged in film due to potential Salmonella contamination. The affected product was distributed in nine northeastern and mid-Atlantic states.

    Product
    MELON LOUPE/DEW CHUNKS 50/2 OZ. Packaged in film. UPC: 840219178080
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-0538-2024·2023-12-27

    AirTouch F20 Full Face Mask Recalled for Magnetic Interference with Medical Implants

    ResMed recalls 3.8 million AirTouch F20 full face masks with magnets that may interfere with active medical implants. Updated safety warnings regarding safe distances from medical devices are being issued.

    Product
    AirTouch F20 Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0625-2024·2023-12-27

    Fruit Medley Recalled for Salmonella Contamination by FDA

    Renaissance Food Group is recalling Fruit Medley products in 9 oz and 18 oz sizes due to Salmonella contamination. The affected products were distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina.

    Product
    Fruit Medley NET WT 9 OZ (255 g) UPC 8 26766 13927 9 & 18 OZ (1 LB 2 OZ) 510 g UPC 8 26766 13921 7 Dist. By: Renaissance Food Group LLC 4322 Moreland Ave Conley, GA 30288
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0650-2024·2023-12-27

    HMC Farms Nectarines Recalled Due to Listeria Contamination Risk

    HMC Farms Nectarines 4lb bags are recalled due to potential Listeria monocytogenes contamination. The recall affects 26 US states, Mexico, Canada, and Taiwan.

    Product
    HMC Farms Nectarines 4lb bag
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Devices)·Z-0515-2024·2023-12-27

    Sterile Water Syringes recalled for lack of sterility assurance

    Nurse Assist LLC recalls sterile water injection and irrigation syringes for inadequate sterility assurance. Affected products may be nonsterile and could cause infection if used.

    Product
    Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0675-2024·2023-12-27

    Fruit Tray with Dip Recalled Due to Potential Salmonella Contamination

    TGD Cuts, LLC is recalling fruit trays with dip due to potential Salmonella contamination. The affected products were distributed across nine states in the Northeast and Mid-Atlantic regions.

    Product
    FRUIT TRAY W/DIP 3/5 LB, 3/36 OZ, 3/56 OZ, and 3/40OZ UPCs: 840219175454, 840219195926, and 840219171777. Packaged in trays.
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0619-2024·2023-12-27

    Kwik Trip Cantaloupe Recalled for Potential Salmonella Contamination

    Kwik Trip Cantaloupe (Item 930541, 6 oz) is being recalled due to potential Salmonella contamination. Affected products were distributed in Iowa, Illinois, Michigan, Minnesota, South Dakota, and Wisconsin with sell-by dates from November 4 to December 3, 2023.

    Product
    Kwik Trip Cantaloupe, Item 930541. Net Wt 6 oz (170g). UPC 0 39779-00213 7. Produced & Distributed by Kwik Trip Inc., La Crosse WI
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0539-2024·2023-12-27

    AirFit N20 Nasal Mask: Magnetic Interference with Medical Implants

    ResMed AirFit N20 Nasal Masks contain magnets that may interfere with active medical implants and ferromagnetic objects. The FDA classified this as Class I; ResMed is updating safety warnings with required distances.

    Product
    AirFit N20 Nasal Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0608-2024·2023-12-27

    RAPIDPoint 500 Measurement Cartridge Sodium Sensor May Cause Measurement Error

    Siemens RAPIDPoint 500 cartridges may produce inaccurate sodium measurements in blood samples, potentially delaying diagnosis or causing inappropriate treatment. The sodium sensor may show a negative bias, affecting patient care.

    Product
    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2024·2023-12-27

    Acrobat-i Vacuum Positioner System Recalled for Positioner Arm Locking Failure

    Maquet Cardiovascular is recalling the Acrobat-i Vacuum Positioner System because the positioner arm may fail to tighten or lock during normal use, which could affect surgical positioning.

    Product
    Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0609-2024·2023-12-27

    RAPIDPoint 500 Measurement Cartridge Sodium Sensor Negative Bias Risk

    Siemens RAPIDPoint 500 measurement cartridges may produce inaccurate sodium readings, risking delayed diagnosis of dangerous electrolyte imbalances or unnecessary treatment.

    Product
    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0154-2024·2023-12-27

    Nystatin bulk powder recall due to incorrect assay strength label

    Fagron, Inc. is recalling Nystatin 5BU bulk powder for prescription compounding due to an incorrect assay strength label. The product was distributed to pharmacies and repacker/relabelers in the United States and Canada.

    Product
    NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0559-2024·2023-12-27

    Philips Azurion Ceiling-Mount Systems Rotation Cover May Fall

    Philips is recalling Azurion ceiling-mount imaging systems because a rotation cover may fall if the L-arm collides with hospital equipment, potentially causing injury or affecting sterilization.

    Product
    Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0579-2024·2023-12-27

    Exactech Equinoxe Shoulder System recalled for vacuum loss in bags

    Exactech Equinoxe Reverse Shoulder implants have been recalled due to loss of vacuum in the storage bag. The manufacturer received 3 complaints involving 4 devices.

    Product
    Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n)…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0567-2024·2023-12-27

    AC Power Adapter for LIFEPAK 15 Defibrillator May Fail to Charge or Power On

    AC power adapters for LIFEPAK 15 Monitor/Defibrillators may fail to charge batteries or power on the device. Physio-Control is recalling 18,732 units manufactured between November 2021 and April 2023.

    Product
    AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0576-2024·2023-12-27

    Philips Inclusive CT Systems: Software Errors in Image Display and Interpretation

    Philips North America is recalling 330 Philips Inclusive CT imaging systems due to software issues causing incorrect image display, errors in image interpretation, and patient exposure to incorrect images and system functions during clinical use.

    Product
    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment…
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0581-2024·2023-12-27

    Exactech Novation Hip System Recalled for Vacuum Seal Loss

    Exactech is recalling the Novation Hip System due to loss of vacuum in the sterile packaging. The company has received complaints about this defect affecting 4 devices.

    Product
    Exactech Novation Hip System, Catalog Numbers: 134-36-45
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0585-2024·2023-12-27

    Exactech Truliant Knee System Recalled Due to Vacuum Bag Failure

    Exactech recalls certain Truliant Knee System units due to loss of vacuum in the inner vacuum bag. The affected units were distributed across multiple U.S. states and international locations.

    Product
    Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0566-2024·2023-12-27

    CardioQuip Modular Cooler-Heater Model MCH-1000(m) Recalled for Bacterial Contamination

    CardioQuip LLC is recalling 2 units of its Model MCH-1000(m) Modular Cooler-Heater due to potential bacterial contamination that could result in patient infection. The affected devices are distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.

    Product
    CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0558-2024·2023-12-27

    Philips Allura Medical Imaging Systems Ceiling Mount May Fall

    Philips is recalling Allura imaging systems where the ceiling-mounted rotation cover may fall during equipment collisions, risking injury or sterility issues. Approximately 9,991 units are affected worldwide.

    Product
    Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2024·2023-12-27

    Exactech Optetrak Logic Knee System Recalled for Vacuum Bag Failure

    Exactech is recalling certain Optetrak Logic Knee System devices due to loss of vacuum in the inner-most vacuum bag. The company has received three complaints involving four affected devices.

    Product
    Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0587-2024·2023-12-27

    Exactech Vantage Ankle System Recalled Due to Vacuum Loss

    Exactech is recalling two catalog numbers of Vantage Ankle System devices due to loss of vacuum in the inner-most vacuum bag. Three complaints have been received relating to four affected devices.

    Product
    Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0601-2024·2023-12-27

    Siemens epoc NXS Blood Analysis System Software Causes Erroneous Test Results

    Siemens epoc NXS blood analysis systems have a software defect causing incorrect test results to be printed or transmitted. Results may include data from previous patients, potentially leading to misdiagnosis.

    Product
    epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0610-2024·2023-12-27

    LITe Decompression Snake Arm cannot attach due to incorrect clamp component

    Stryker Spine is recalling 9 units of the LITe Decompression Snake Arm due to an incorrect clamp component that prevents proper attachment to the arm post shaft. Affected units were distributed in the US and internationally.

    Product
    LITe Decompression Snake Arm, REF 48080230
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Drugs)·D-0155-2024·2023-12-27

    Nystatin Powder Recall Due to Incorrect Assay Strength on Label

    Fagron, Inc. is recalling 46 containers of Nystatin 500 MU bulk powder used for prescription compounding due to an incorrect assay value on the product label. The mislabeled strength could affect proper compounding of patient medications.

    Product
    NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0604-2024·2023-12-27

    Abbott Hematology Analyzers Recalled for Unlabeled Latex Component

    Abbott CELL-DYN Ruby and Sapphire hematology analyzers contain latex that is not labeled on the device, posing a risk to users with latex allergies. The recall affects 670 devices distributed across 33 states, Puerto Rico, and Brazil.

    Product
    Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0575-2024·2023-12-27

    Surgical Injection Needles Recalled for Uncertain Manual Cleaning Efficacy

    Karl Storz Endoscopy injection needles used in surgery may not be reliably cleaned by hand, exposing patients to higher infection risk. The recall affects 4,878 units.

    Product
    Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0569-2024·2023-12-27

    Orthopedic implant head recall due to incorrect adapter in packaging

    Biomet's Biolox ceramic hip implant heads were shipped with the wrong adapter component. The adapter had an incorrect neck length (M/+0 instead of S/-3.0) that differs in size marking.

    Product
    Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Drugs)·D-0156-2024·2023-12-27

    Nystatin Bulk Powder Recalled Due to Incorrect Label Strength

    Fagron Inc. is recalling 9 containers of Nystatin 2 BU bulk powder because the assay value on the label is incorrect, which could affect dosing accuracy in pharmacy compounding.

    Product
    NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-4, Bar code 3 51552 00414 6
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0152-2024·2023-12-27

    Selenium Sulfide 2.25% Shampoo Recalled Due to Unsupported Expiry Date

    Private Label Partners, Inc. recalls Selenium Sulfide 2.25% Shampoo (3,396 bottles, Lot #220551) due to stability data insufficient to support the labeled expiration date. Affected product distributed in New Jersey.

    Product
    Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0606-2024·2023-12-27

    Frozen Spinach Artichoke Pizzas Recalled for Undeclared Wheat

    Shakespeare's Pizza recalls 7,103 units of frozen Spinach Artichoke Pizza sold in Missouri and Kansas due to undeclared wheat. Consumers with wheat allergies should not consume the product.

    Product
    Shakespeare's Pizza, Spinach Artichoke Pizza, 25 oz, Keep Frozen; UPC 686 148 000 043; pack size 18 per case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0570-2024·2023-12-27

    Biomet Recalls Hip Implant Adapter Due to Wrong Specification in Packaging

    Biomet is recalling a hip implant adapter lot due to incorrect packaging containing the wrong adapter specification. The mismatch could result in incorrect implant selection during surgery if not detected before use.

    Product
    Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0565-2024·2023-12-27

    CardioQuip Modular Cooler-Heater Device Recalled for Potential Bacterial Contamination

    CardioQuip is recalling the Modular Cooler-Heater (Model MCH-1000i) due to potential bacterial contamination that could cause patient infection. Four units were distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.

    Product
    CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0606-2024·2023-12-27

    RAPIDPoint 500 Measurement Cartridges Recalled for Sodium Sensor Bias

    Siemens is recalling RAPIDPoint 500 Systems Measurement Cartridges because the sodium sensor can develop a negative measurement bias that could delay diagnosis of serious electrolyte disorders or cause treatment errors.

    Product
    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813
    Category
    Medical Device
    Distribution
    Distributed nationwide

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