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.

476–500 of 3531

  • ModerateCPSC·24368·2024-09-19

    Wee Gallery Baby Tummy Time Gallery Recalled for Phthalate Violation

    Wee Gallery is recalling about 8,000 Baby Tummy Time Gallery products because the clear plastic pockets contain phthalate levels that exceed federal limits. Phthalates are toxic if ingested by young children.

    Product
    Baby Tummy Time Gallery
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1806-2024·2024-09-18

    Walmart Macaroni Salad Recalled Due to Foreign Material

    Reser's Fine Foods is recalling Walmart Original Freshness Guaranteed Macaroni Salad due to foreign material contamination. Affected product has UPC 78742 02670 with a Use By date of Sep 18, 2024.

    Product
    UPC 78742 02670, Walmart Original Freshness Guaranteed Macaroni Salad 3lb. (48oz), refrigerated, packaged in an opaque printed plastic tub with a plastic white printed lid. There are 6 tubs per case.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-3079-2024·2024-09-18

    FDA Recalls Syringe Tip Caps Due to Unapproved Device Modifications

    Sol-Millennium Medical Inc. is recalling certain Syringe Tip Cap models because they were modified without proper FDA clearance. The modified devices differ from their approved specifications.

    Product
    Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3073-2024·2024-09-18

    Medtronic InterStim Handset May Fail to Pair with Communicator

    Medtronic is recalling 211 InterStim Smart Programmer handsets that may not complete the pairing process with the communicator during initial setup.

    Product
    Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1802-2024·2024-09-18

    Reser's Spicy Pickle Potato Salad Recalled for Foreign Material

    Reser's American Classics Spicy Pickle Potato Salad (16 oz, UPC 71117 19084) is being recalled due to possible foreign material contamination. The voluntary recall affects products distributed across nine states.

    Product
    UPC 71117 19084, Reser's American Classics Spicy Pickle Potato Salad 16oz, refrigerated, packaged in an opaque printed plastic tub with a plastic red printed lid. There are 6 tubs per case.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-3120-2024·2024-09-18

    Medline recalls surgical convenience kits in Class II recall

    Medline Industries is voluntarily recalling 720 units of convenience kits containing semi-rigid suction liners used in eye surgery and related procedures. The specific reason for the recall has not been disclosed.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, Pack Number DYNJ59921BH; c) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923B; d) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923BH;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3098-2024·2024-09-18

    Vital Signs Monitor Recalled Due to Inadequate Battery Warning Labels

    Zoe Medical is recalling 6,429 Spacelabs Ultraview DM3 Vital Signs Monitors because labeling does not adequately warn users about risks from damaged or expired batteries.

    Product
    Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1804-2024·2024-09-18

    Amazon Fresh Macaroni Salad recalled for foreign material contamination

    Reser's Fine Foods is recalling Amazon Fresh Fresh Classic Macaroni Salad due to foreign material contamination. The product was distributed in nine states with a use-by date of September 13, 2024.

    Product
    UPC 95515 04502, Amazon Fresh Fresh Classic Macaroni Salad 16oz, refrigerated, packaged in a clear plastic tub with printed labels on top, bottom and side. There are 12 tubs per case.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0658-2024·2024-09-18

    Fluoride Dental Product Recalled Due to Label Mix-Up

    Just Right 5000 fluoride dental product is being recalled due to a label mix-up affecting 120 direct customers nationwide.

    Product
    Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3094-2024·2024-09-18

    Reprocessed Surgical Sealer/Divider Recalled for Potential Packaging Seal Defect

    Medline Industries is recalling the ReNewal Reprocessed Covidien LigaSure Impact Sealer/Divider due to a potential incomplete seal on the packaging tray. The recall affects 230 units nationwide.

    Product
    Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3112-2024·2024-09-18

    Medline Suction Liners Recalled Due to Potential Loss of Suction

    Medline is recalling 1,616 units of semi-rigid suction liners (ENDO KIT, pack numbers DYKE1350D and DYKE1514B) manufactured September to November 2023 that may lose or provide reduced suction during use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3103-2024·2024-09-18

    Diagnostic test shows measurement bias at critical threshold

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 19-9 test kits due to positive bias in measurements around the critical threshold of 35 U/mL, affecting diagnostic accuracy.

    Product
    ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239
    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 (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-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-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 (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 (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 (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 (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 (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-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 (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 (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-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