The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

2501–2525 of 21589

  • ModerateFDA (Devices)·Z-2953-2024·2024-09-11

    Philips Azurion 7M20 Fluoroscopic X-Ray System FlexArm Movement Recall

    Philips Azurion 7M20 interventional fluoroscopic X-ray systems with FlexArm ceiling-mounted stands may experience inconsistent or unavailable longitudinal movement due to bearing grease leakage affecting device mobility. Approximately 927 systems worldwide are affected.

    Product
    Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1767-2024·2024-09-11

    Refrigerated Macaroni & Cheese Recalled for Potential Spoilage from Temperature Abuse

    Reser's American Classics Macaroni & Cheese White Cheddar (12oz) is recalled due to potential spoilage caused by temperature abuse during distribution. Consumers should discard affected packages.

    Product
    Item 71117.02009, Reser's American Classics Macaroni & Cheese White Cheddar, refrigerated product, net wt. 12oz. There are 6 packs per case.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2960-2024·2024-09-11

    Impella CP Cardiac Assist Pump Lacks Shockwave Catheter Interaction Warning

    Abiomed is updating labeling for Impella CP Smart Assist pumps to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. The interaction was previously undocumented in device labeling.

    Product
    Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2957-2024·2024-09-11

    Abiomed updates Impella CP labeling for Shockwave coronary catheter interaction

    Abiomed is recalling the Impella CP Pump 371 Set due to a potential device interaction with the Shockwave Coronary IVL Catheter. The manufacturer is updating labeling to address this interaction. No illnesses or injuries have been reported.

    Product
    Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1772-2024·2024-09-11

    Reser's Egg Salad Recalled Due to Temperature Abuse During Shipping

    Reser's American Classics Egg Salad has been recalled due to potential spoilage caused by temperature abuse from a malfunctioning refrigeration unit. The affected product was distributed in five states.

    Product
    Item 71117.11356, Reser's American Classics Egg Salad, refrigerated product, net wt. 12oz. There are 6 packs per case.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-1768-2024·2024-09-11

    Reser's Asiago Creamed Spinach recalled due to potential spoilage

    Reser's Fine Foods recalls Asiago Creamed Spinach due to potential spoilage from temperature abuse during transport. The affected product has a use-by date of August 31, 2024.

    Product
    Item 71117.02126, Reser's American Classics Asiago Creamed Spinach, refrigerated product, net wt. 12oz. There are 6 packs per case.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-1770-2024·2024-09-11

    Reser's Macaroni & Cheese Recalled for Temperature Abuse During Shipment

    Reser's American Classics Macaroni & Cheese (12 oz) is recalled because a malfunctioning refrigeration unit caused temperature abuse during shipment, which may cause spoilage.

    Product
    Item 71117.02123, Reser's American Classics Macaroni & Cheese, refrigerated product, net wt. 12oz. There are 6 packs per case.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2967-2024·2024-09-11

    Impella CP Smart Assist Set Recalled for Device Interaction Labeling Update

    Abiomed is updating labeling for ImpellaCP SmartAssistSetAPAC to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. Eight units were distributed worldwide.

    Product
    ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1765-2024·2024-09-11

    Reser's Essential Everyday Potato Salad recalled for spoilage risk from temperature abuse

    Reser's Essential Everyday Original Potato Salad recalled due to potential spoilage from temperature abuse affecting refrigerated units. Affected cases distributed in CA, IL, MN, ND, and SD.

    Product
    Item 41303.82013, Reser's Essential Everyday Original Potato Salad, refrigerated product, net wt. 16oz. There are 6 packs per case.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2954-2024·2024-09-11

    Impella CP Smart Assist Set: Device interaction safety labeling update

    Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. No illnesses or injuries have been reported.

    Product
    Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1778-2024·2024-09-11

    Reser's Sweet Corn with Butter recalled due to temperature abuse

    Reser's recalls 104 cases of sweet corn with butter due to shipment temperature abuse that may cause spoilage. Use By date Sept. 9, 2024; distributed in CA, IL, MN, ND, and SD.

    Product
    Item 71117.56013, Reser's Sweet Corn with Butter, refrigerated product, net wt. 4lb. There are 4 packs per case.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2963-2024·2024-09-11

    Abiomed Impella 5.5 Recall for Potential Shockwave Catheter Interaction

    Abiomed is recalling 2,916 Impella 5.5 units to update labeling regarding a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions.

    Product
    Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2961-2024·2024-09-11

    Impella 5.5 with SmartAssist Set: Potential Device Interaction During Coronary Interventions

    Abiomed is updating labeling for Impella 5.5 with SmartAssist Set due to a potential device interaction with Shockwave Coronary IVL Catheter during coronary interventions. The product labeling currently lacks information about this potential interaction.

    Product
    Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2971-2024·2024-09-11

    Impella 5.5 Cardiac Pump Recalled for Undocumented Device Interaction

    Abiomed recalled 413 units of Impella 5.5 with SmartAssist S2 pumps worldwide due to a potential undocumented interaction with Shockwave coronary catheters during cardiac procedures. The company will update product labeling to disclose this interaction.

    Product
    Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2962-2024·2024-09-11

    Impella 5.5 Cardiac Pump Labeling Updated for Device Interaction Risk

    Abiomed is updating documentation for the Impella 5.5 cardiac pump to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. The notice affects 21 units distributed worldwide.

    Product
    Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2959-2024·2024-09-11

    Abiomed Impella Pump Recall for Potential Shockwave Catheter Interaction

    Abiomed is recalling 43,636 Impella Pumps to update instructions for use regarding a potential interaction with Shockwave Coronary IVL Catheters.

    Product
    Pump 371 14F LT CMR Set; Product Code: 0048-0045;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1773-2024·2024-09-11

    Baked Scalloped Potatoes Recalled Due to Temperature Abuse During Distribution

    Reser's Fine Foods recalls Baked Scalloped Potatoes due to potential spoilage from temperature abuse during shipment. Affected products have Use By dates of September 11–13, 2024.

    Product
    Item 71117.14378, Baked Scalloped Potatoes Special Request, refrigerated product, net wt. 2.5lb. There are 8 packs per case.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2855-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Voluntarily Recalled

    BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001305;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2874-2024·2024-09-04

    Beaver Visitec recalls CustomEyes Procedure Packs with Sol-M syringes

    Beaver Visitec International is voluntarily recalling 216 units of BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-M. The recall affects nationwide distribution.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001484;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2801-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Defective Sol-M Syringes Recalled Nationwide

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain defective syringes made by Sol-Millennium Medical. The voluntary recall affects 149 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000195;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2932-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are being recalled in a voluntary action. 207 units with Part Number 58001999 are distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001999;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2925-2024·2024-09-04

    BVI CustomEyes Procedure Packs recalled due to incorrect syringes

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain syringes manufactured by Sol-Millennium Medical instead of the intended product. The recall involves 57 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001933;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2847-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes due to a voluntary recall by the syringe manufacturer. The recall affects 43 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001138;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2889-2024·2024-09-04

    BVI CustomEyes Procedure Packs recalled for Sol-M syringe defects

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes due to a voluntary recall initiated by the syringe manufacturer. No illnesses or injuries have been reported.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001608;
    Category
    Medical Device
    Distribution
    Distributed nationwide