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.

7426–7450 of 52964

  • HighFDA (Drugs)·D-0653-2024·2024-09-11

    Compounded Semaglutide Recalled Due to Lack of Sterility Assurance

    ProRx LLC is recalling 1,960 vials of compounded semaglutide nationwide due to lack of assurance of sterility. The multiple-dose vials may not meet sterility standards for injectable medications.

    Product
    SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2949-2024·2024-09-11

    Sevoflurane Vaporizer for A9 Anesthesia System Recalled for Output Malfunction

    Mindray recalled 2 Sevoflurane E_Vap vaporizers used in A9 Anesthesia Systems due to a component defect causing excessive anesthetic output. The defect risks patient anesthetic overdose with potential neurological effects including post-operative vertigo and drowsiness.

    Product
    Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Drugs)·D-0654-2024·2024-09-11

    ProRx Compounded Semaglutide/Cyanocobalamin Injection Recalled Due to Sterility Assurance Issues

    ProRx LLC is recalling 500 vials of compounded Semaglutide/Cyanocobalamin Injection (Lot #ProRx031924-1) distributed nationwide in the United States due to lack of sterility assurance. The beyond-use date is 09/18/2024.

    Product
    Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2970-2024·2024-09-11

    Impella 5.5 SmartAssist S2 Labeling Updated for Shockwave Catheter Interaction

    Abiomed is updating labeling for the Impella 5.5 SmartAssist S2 cardiac assist device to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions.

    Product
    Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1774-2024·2024-09-11

    Reser's Creamy Deluxe Potatoes Recalled for Temperature Abuse Risk

    Reser's Fine Foods is recalling 182 cases of Potatoes Creamy Deluxe Special Request due to temperature abuse that may cause food spoilage.

    Product
    Item 71117.14446, Potatoes Creamy Deluxe Special Request, refrigerated product, net wt. 5lb. There are 4 packs per case.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1766-2024·2024-09-11

    Reser's American Classics Scalloped Potatoes Recalled Due to Temperature Abuse

    Reser's Fine Foods is recalling Reser's American Classics Scalloped Potatoes because a refrigeration unit malfunction caused temperature abuse during shipment, potentially leading to spoilage. Consumers should not consume this product.

    Product
    Item 71117.02008, Reser's American Classics Scalloped Potatoes, refrigerated product, net wt. 12oz. There are 6 packs per case.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1780-2024·2024-09-11

    Ham and Cheese Croissants Recalled for Potential Listeria Contamination

    WR Coffee Inc recalled 90 Ham and Cheese Croissants distributed in Texas due to potential Listeria monocytogenes contamination.

    Product
    Ham and Cheese Croissant (approximately 6.5 oz) delivered fresh in bins to the firm's Restaurants- no label. Not individually packaged.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2966-2024·2024-09-11

    Impella 5.5 Pump Labeling Updated Due to Device Interaction

    Abiomed updated Impella 5.5 cardiac pump labeling to document a potential interaction with Shockwave Coronary IVL Catheter during coronary procedures. No injuries have been reported.

    Product
    Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2946-2024·2024-09-11

    W L Gore Recalls Heparin Viabahn VBX Endoprosthesis Due to Packaging Defects

    W L Gore & Associates is recalling specific lots of Heparin, Gore Viabahn VBX Balloon Expandable Endoprosthesis because packaging defects may compromise sterility and heparin activity.

    Product
    Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *Fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2979-2024·2024-09-11

    Power Express PE Centrifuge adhesive joint failure may cause component detachment

    The adhesive joint in this medical device component can fail, causing the metal part to detach. This may damage the centrifuge, destroy patient samples, and potentially expose lab staff to biohazardous material.

    Product
    PE Centrifuge, REF: B36365, a component of the Power Express
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2955-2024·2024-09-11

    Impella CP Smart Assist Set Lacks Labeling for Potential Device Interaction

    Abiomed is updating labeling for the Impella CP Smart Assist Set to warn about a potential interaction with the Shockwave Coronary IVL Catheter when used during coronary interventions. The interaction was previously undocumented in the device instructions.

    Product
    Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2964-2024·2024-09-11

    Pump 381 Pump Set lacks labeling for Shockwave catheter interaction risk

    Abiomed's Pump 381 Pump Set labeling lacks information about potential interactions with Shockwave Coronary IVL Catheters during coronary interventions. The manufacturer is updating instructions for use to address this gap.

    Product
    Pump 381 Pump Set (US); Product Code: 1000080;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2951-2024·2024-09-11

    Anesthesia System Vaporizer Adapter Recalled for Potential Anesthetic Overdose

    Mindray's Isoflurane E_Vap adapter for the A9 Anesthesia System is recalled due to a seal defect that may cause higher-than-intended anesthetic concentration delivery. Twenty-four units were distributed to eight U.S. states and Canada.

    Product
    Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number 115-066758-00
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2978-2024·2024-09-11

    Medical Device Sample Holder Recalled for Adhesive Joint Failure

    Beckman Coulter Power Express sample holders can fail at the adhesive joint between plastic socket and metal component. This may cause the metal part to detach inside the centrifuge, potentially damaging equipment and exposing lab staff to biohazardous material.

    Product
    Power Express, REF B90918
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1779-2024·2024-09-11

    Ground Cinnamon Recalled Nationwide for Elevated Lead Levels

    MAMTAKIM Inc. is recalling ground cinnamon products distributed to nine states due to elevated lead content. The 15 g paper carton product carries code 10C035.

    Product
    Scortisoara macinata/ Ground cinnamon, 15 g, Paper cartons, 20 pieces per paper carton
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2956-2024·2024-09-11

    Impella CP Pump Set Recalled for Potential Device Interaction

    Abiomed is recalling the Impella CP Pump Set due to a potential device interaction with the Shockwave Coronary IVL Catheter during coronary interventions. The manufacturer will update device instructions to address this interaction.

    Product
    Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1784-2024·2024-09-11

    Pita Jungle Hummus & Pita Chips Recalled for Undeclared Sesame Allergen

    Pita Jungle Hummus & Pita Chips snack packs are being recalled because the product label fails to declare sesame, an ingredient in the hummus. Consumers with sesame allergies may face health risks.

    Product
    Pita Jungle Hummus & Pita Chips packaged as individual "snack pack" in 9.2oz clamshell plastic container.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1782-2024·2024-09-11

    Pita Jungle Greek Salad Recalled for Undeclared Milk Allergen

    SSP America PHX, LLC recalls Pita Jungle Greek Salad (11.8oz clamshell) because the product label listed feta but failed to declare milk as an allergen. Consumers with milk allergies should not consume this product.

    Product
    Pita Jungle Greek Salad packaged in 11.8oz plastic clamshell container.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2965-2024·2024-09-11

    Impella 5.5 Device Recalled for Missing Labeling on Catheter Interaction

    Abiomed is updating labeling for Impella 5.5 cardiac support pumps to include information about a potential device interaction with Shockwave Coronary IVL Catheters during coronary interventions.

    Product
    Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V661000·2024-09-10

    McLaren Recalls 2020-2023 GT Models Due to Hood Latch Defect

    McLaren is recalling 2020-2023 GT vehicles because the hood latch cable may have excessive tension, causing the hood to open unexpectedly and obstruct the driver's view.

    Product
    MCLAREN — MCLAREN GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V663000·2024-09-10

    Alliance RV Valor travel trailers recalled for missing electrical shock protection

    Alliance RV is recalling certain 2024-2025 Valor travel trailers where the front bathroom outlet may lack Ground Fault Interrupter (GFI) protection. This missing safety feature can result in electrical shock.

    Product
    ALLIANCE RV — ALLIANCE RV VALOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V668000·2024-09-10

    Freightliner and Western Star brake lights may fail during emergency braking

    Daimler Trucks is recalling certain Freightliner and Western Star trucks because brake lights may fail to illuminate during automatic emergency braking, increasing crash risk. Dealers will update software at no cost.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR EM2, 57X, 47X, 108SD
    Category
    Vehicle
    Distribution
    Distributed nationwide