The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

16751–16775 of 53124

  • HighFDA (Devices)·Z-1359-2022·2022-07-20

    MiniMed 780G Insulin Pump battery cap deterioration may cause power loss

    Medtronic MiniMed is recalling 83,398 MiniMed 780G insulin pumps distributed throughout the United States due to battery cap deterioration that may cause power loss and device malfunction.

    Product
    MiniMed 780G Insulin Pump (O.U.S. Version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1367-2022·2022-07-20

    Anti-SARS-CoV-2 IgG Reagent: Stability Time Overstated in Instructions

    Ortho-Clinical Diagnostics is recalling Anti-SARS-CoV-2 IgG Quantitative Reagent Pack because the Instructions For Use incorrectly state on-analyzer stability of 8 weeks when the actual supported time is 6 weeks.

    Product
    Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1220-2022·2022-07-20

    Nandrolone Decanoate Injectable Vials Recalled for Lack of Sterility Assurance

    Tailor Made Compounding is recalling 243 vials of Nandrolone Decanoate injectable medication due to lack of sterility assurance. The affected product was distributed nationwide in the USA and Puerto Rico.

    Product
    Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1219-2022·2022-07-20

    NAD+ Injectable Vials Recalled Due to Lack of Sterility Assurance

    Tailor Made Compounding is recalling 1,856 vials of NAD+ 200mg/mL because the company cannot assure the product meets sterility requirements. The affected vials were distributed nationwide to the United States and Puerto Rico.

    Product
    NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1353-2022·2022-07-20

    MiniMed 630G Insulin Pump Recalled for Battery Cap Deterioration

    Medtronic MiniMed is recalling the MiniMed 630G insulin pump due to battery cap deterioration that may cause loss of power and function. Approximately 126,558 units distributed in the U.S. and Canada are affected.

    Product
    MiniMed 630G Insulin Pump (U.S. and Canada Version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1358-2022·2022-07-20

    MiniMed 770G Insulin Pump Battery Cap May Deteriorate, Causing Power Loss

    Medtronic is recalling MiniMed 770G insulin pumps because battery cap deterioration may cause power loss and insulin delivery failure. Approximately 123,585 units are affected.

    Product
    MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1364-2022·2022-07-20

    AquaBplus Water Purification System installation guideline error reduces disinfection

    AquaBplus 2000 water purification systems for dialysis have an installation guideline error that may reduce heat disinfection effectiveness. Patients using affected units may be at risk.

    Product
    AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1352-2022·2022-07-20

    MiniMed 620G insulin pump battery cap deterioration may cause power loss

    Medtronic MiniMed 620G insulin pumps may experience battery cap deterioration, resulting in incomplete battery circuit and loss of power. Approximately 2,287 affected pumps have been distributed across the U.S.

    Product
    MiniMed 620G Insulin Pump (O.U.S. version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1368-2022·2022-07-20

    Dental bonding primer may lack resin component affecting restoration

    Ultradent Peak Universal Bond self-etch dental primers may be missing resin, potentially compromising bond strength. Affected products were distributed nationwide and internationally.

    Product
    Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1210-2022·2022-07-20

    Compounded injectable product recalled for lack of sterility assurance

    Tailor Made Compounding is recalling 25 vials of a compounded injectable product due to lack of assurance of sterility. The affected batches were distributed nationwide.

    Product
    Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1206-2022·2022-07-20

    Tailor Made Compounding Recalls Glycyrrhizic Acid Injectable for Lack of Sterility Assurance

    Tailor Made Compounding recalls 101 vials of Glycyrrhizic Acid (8mg/mL) nationwide due to lack of assurance of sterility in this injectable preparation. Patients should contact their healthcare provider.

    Product
    Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1360-2022·2022-07-20

    Isopure IsoMix PRO Mixing System Electrical Short Recall

    Isopure is recalling approximately 119 units of the Sodium Bicarbonate Mixing and Distribution System due to an electrical short causing a thermal event and device damage. No injuries reported.

    Product
    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Drugs)·D-1218-2022·2022-07-20

    Methylene Blue Hypotonic Solution Vials Recalled for Sterility Assurance Failure

    Methylene Blue Hypotonic Solution vials are being recalled nationwide and in Puerto Rico due to lack of assurance of sterility. Affected vials should not be used.

    Product
    Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1412-2022·2022-07-20

    Slap Ya Mama Cajun Fish Fry Recalled for Undeclared Wheat Allergen

    Walker & Sons Inc is recalling Slap Ya Mama Cajun Fish Fry due to undeclared wheat allergen. Consumers with wheat allergies should not consume the product.

    Product
    Slap Ya Mama Louisiana Food Products Slap Ya Mama Cajun Fish Fry packaged in a 5.5lb plastic container with plastic screw top - 4 units per case UPC 8 17885 00027 4
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1326-2022·2022-07-20

    Radiography System Firmware Error May Cause Incorrect Radiation Dose

    Philips DigitalDiagnost 4 radiography systems may deliver incorrect radiation doses due to a Wallstand VS2 firmware issue causing incorrect image orientation and misaligned anatomical markers.

    Product
    DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1222-2022·2022-07-20

    Procaine HCL Injectable Recalled Due to Sterility Assurance Concerns

    Tailor Made Compounding is recalling Procaine HCL 2% injectable solution due to lack of sterility assurance. The recall affects 58 vials distributed nationwide.

    Product
    Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1325-2022·2022-07-20

    Philips ProxiDiagnost N90 radiography system: firmware issue causes incorrect radiation dose

    Philips is recalling 140 ProxiDiagnost N90 radiography systems due to a firmware issue in the Wallstand VS2 component. After system restart or first exposure with Wallstand VS2, the system may deliver incorrect radiation doses and misposition anatomic markers.

    Product
    ProxiDiagnost N90. radiography and fluoroscopy system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1355-2022·2022-07-20

    MiniMed 670G Insulin Pump Battery Cap Defect Causing Power Loss

    MiniMed 670G Insulin Pump may lose power due to battery cap deterioration, affecting approximately 279,251 units distributed in the U.S. and overseas.

    Product
    MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Drugs)·D-1243-2022·2022-07-20

    Glutathione Injectable Vials Recalled Due to Sterility Assurance Concerns

    Tailor Made Compounding is recalling Glutathione 200mg/ml injectable vials due to lack of assurance of sterility. The recall affects 485 vials distributed nationwide in the USA and Puerto Rico.

    Product
    Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1203-2022·2022-07-20

    FDA Recalls Tailor Made Compounding GAC Injectable Vials for Lack of Sterility Assurance

    Tailor Made Compounding is recalling 90 vials of GAC (Glutamine/Arginine/L-Carnitine) injectable solution distributed nationwide and in Puerto Rico due to lack of assurance of sterility.

    Product
    GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1223-2022·2022-07-20

    PT-141 10mg/mL Injectable Vials Recalled for Sterility Assurance Concerns

    Tailor Made Compounding is recalling PT-141 10mg/mL vials nationwide due to inability to assure sterility. The recall affects 392 vials in 1mL and 2mL sizes distributed in 2022.

    Product
    PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1224-2022·2022-07-20

    Semaglutide/Cyanocobalamin Injectable Recalled for Lack of Sterility Assurance

    Tailor Made Compounding is recalling 5,842 vials of compounded semaglutide/cyanocobalamin injectable due to lack of sterility assurance. The product was distributed nationwide in the United States and Puerto Rico.

    Product
    Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1236-2022·2022-07-20

    Compounded Testosterone Injection Recalled Due to Lack of Sterility Assurance

    Tailor Made Compounding is recalling 176 vials of testosterone cypionate/propionate injectable due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Testosterone Cypionate/Propionate 180/20mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1235-2022·2022-07-20

    Testosterone Injections Recalled for Lack of Sterility Assurance

    Tailor Made Compounding is recalling 246 vials of compounded testosterone injections distributed nationwide due to lack of assurance of sterility. Non-sterile injectable medications may pose a risk of infection.

    Product
    Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V514000·2022-07-20

    Volkswagen Atlas Cross Sport Rearview Camera Software Defect Recall

    Volkswagen is recalling certain 2021-2022 Atlas Cross Sport vehicles due to an infotainment system defect that may prevent the rearview camera image from displaying. This loss of rear visibility increases crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN TAOS, ATLAS, TIGUAN, JETTA
    Category
    Vehicle
    Distribution
    Distributed nationwide