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.

2976–3000 of 21589

  • ModerateFDA (Devices)·Z-1282-2024·2024-03-20

    Infusion Pump Software Defect Causes Incorrect Alarm and Therapy Delay

    Fresenius Kabi is recalling software versions 5.0.1 and earlier of the Ivenix Infusion System due to a software defect that may cause an incorrect pump alarm, potentially delaying therapy. The defect was resolved in software version 5.2.1, released in September 2022.

    Product
    LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·24160·2024-03-14

    Tracker Off Road OX EV Light Utility Vehicles Recalled for Fire Hazard

    About 500 Tracker Off Road OX EV vehicles are being recalled due to water entering the lithium-ion battery pack, which can cause a fire. No injuries have been reported.

    Product
    Tracker Off Road OX EV Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1258-2024·2024-03-13

    Embrace Drill Tower Surgical Instruments Recalled Due to Mixed-Up Type Descriptions

    Waldemar Link recalled Embrace Drill Tower surgical instruments because type descriptions ("standard" vs "wedged") are mixed up in the product overview documentation. Surgeons may select incorrect instrument types due to the confusion.

    Product
    Embrace Drill Tower, Standard/Lateral (25mm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0366-2024·2024-03-13

    Methylprednisolone Acetate Injectable Suspension Recalled for Failed Dissolution

    Eugia US LLC recalls methylprednisolone acetate injection due to failed dissolution specifications. Affected states: Ohio, Tennessee, Louisiana, and Mississippi.

    Product
    METHYLPREDNISOLONE ACETATE — METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1248-2024·2024-03-13

    MRI Systems Show Incorrect Spatial Field Gradient Values

    Canon Medical's MRI systems display incorrect Spatial Field Gradient values that are lower than actual, which may cause discomfort for patients with MR-conditional implanted devices during scanning.

    Product
    MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0365-2024·2024-03-13

    Clindamycin Phosphate Topical Solution recalled due to defective container leakage

    Contract Pharmaceuticals Limited Canada is recalling Clindamycin Phosphate Topical Solution 1% due to defective containers with slow leakage. Lot 119874 (expires 06/30/2025) distributed nationwide in the U.S. and Puerto Rico is affected.

    Product
    Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0364-2024·2024-03-13

    Clindamycin Phosphate Topical Solution recalled for defective container leakage

    Contract Pharmaceuticals Limited Canada is recalling 45,875 bottles of Clindamycin Phosphate Topical Solution USP 1% due to defective containers that leak slowly. The product was distributed nationwide in the U.S. and Puerto Rico.

    Product
    Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0367-2024·2024-03-13

    Mercaptopurine Tablets Recalled Due to Failed Dissolution Specifications

    Stason Pharmaceuticals recalls Mercaptopurine Tablets, USP 50 mg due to failed dissolution specifications at 9 months. Dissolution results were slightly below the required specification.

    Product
    Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1037-2024·2024-03-13

    Frios Gourmet Pops Fruity Pebbles popsicles recalled for undeclared Yellow #5

    Frios Gourmet Pops Fruity Pebbles Popsicles are being recalled due to undeclared Yellow #5 color additive. Consumers with sensitivity or allergy to tartrazine should not consume the product.

    Product
    Frios Gourmet Pops - Fruity Pebbles Popsicle 3oz frozen popsicle packaged individually in clear plastic sleeve. 48 popsicles per box. *Sold directly to end consumer via food truck
    Category
    Food
    Distribution
    17 states
  • ModerateCPSC·24154·2024-03-07

    Textron Arctic Cat Catalyst 600 Snowmobiles Recalled for Brake Loss Risk

    Textron Specialized Vehicles is recalling about 2,700 model year 2024 Arctic Cat Catalyst 600 snowmobiles because the brake line can contact the brake disc, causing brake damage and potential brake loss. No injuries have been reported, but three reports of brake line damage have been received.

    Product
    Model Year 2024 Arctic Cat Catalyst 600 Series Snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1190-2024·2024-03-06

    Abbott M1000 Wash Station Shipped Without U.S. Approval or Registration

    Abbott Molecular recalled M1000 Wash Station units shipped to U.S. customers without FDA approval or registration. The devices were intended for export only and not approved for U.S. distribution.

    Product
    Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1192-2024·2024-03-06

    Dental Prosthetic Material Recall for Machining Defects

    GRAPHENANO Dental G-CAM denture manufacturing material is being recalled due to machining errors that render the product unusable. The recall affects 354 units distributed in Utah.

    Product
    GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF GC00113; f) 95 Multichroma 16LB2, REF GC00131;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1189-2024·2024-03-06

    Abbott Vysis Diagnostic Kits Recalled for U.S. Regulatory Non-Compliance

    Abbott Molecular recalls five Vysis in-vitro diagnostic kits that were intended for export and shipped to U.S. customers without approval or registration per U.S. specifications.

    Product
    In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0357-2024·2024-03-06

    Hand Sanitizer Recalled Nationwide for Manufacturing Practice Deficiencies

    Seatex LLC is recalling PROBLEND E3 Foaming Hand Sanitizer due to manufacturing practice deviations identified during FDA inspection. The recall affects products distributed nationwide in the US and Puerto Rico.

    Product
    PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0358-2024·2024-03-06

    7 Eleven Hand Sanitizer Recalled for Manufacturing Deficiencies

    A hand sanitizer distributed to 7-Eleven gas stations nationwide is being recalled due to manufacturing deficiencies identified during an FDA inspection. The affected product is lot 251176, distributed in the United States and Puerto Rico.

    Product
    7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0360-2024·2024-03-06

    PROBLEND Hand Sanitizer Recalled Due to Manufacturing Deficiencies

    Seatex LLC is recalling PROBLEND Hand Sanitizer (Lot 266029) nationwide due to manufacturing deficiencies identified during FDA inspection.

    Product
    PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0356-2024·2024-03-06

    FDA Recalls PROBLEND Hand Sanitizer for Manufacturing Deviations

    Seatex LLC is recalling 1,450 cases of PROBLEND Antibacterial Foaming Hand Sanitizer due to Current Good Manufacturing Practice (CGMP) deviations discovered at its manufacturing facility. The recall affects product distributed nationwide in the United States and Puerto Rico.

    Product
    PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1188-2024·2024-03-06

    Abbott in-vitro diagnostic kits shipped without U.S. approval or registration

    Abbott Molecular shipped two in-vitro diagnostic FISH probe kits to U.S. customers that were intended for export only and not approved or registered per U.S. specifications. The recall affects 16 kits distributed across eight states.

    Product
    In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1204-2024·2024-03-06

    FDA Recalls Conductive Adhesive Gel for Viscosity Defect

    Parker Laboratories is recalling Tensive Conductive Adhesive Gel due to five complaints regarding incorrect viscosity. The affected product was distributed across multiple US states and internationally.

    Product
    Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Food)·F-0930-2024·2024-03-06

    Healthprint Vitamin D3 5000 recalled for sub-potency and incorrect labeling

    Ancient Formulas' Healthprint Vitamin D3 5000 supplement contains less Vitamin D than claimed and has incorrect daily value labeling. The recall affects 111 bottles distributed in Florida.

    Product
    Healthprint Vitamin D3 5000 Dietary Supplement, 200 tablets, packaged in plastic bottle.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1185-2024·2024-03-06

    EMD Millipore Issues Recall of Schiff Reagent Hotchkiss-McManus for Discoloration

    EMD Millipore has recalled Schiff Reagent Hotchkiss-McManus (lots 3094 and 3096) because units appear pink instead of colorless. Laboratories should discontinue use of affected units distributed to US states and Canada.

    Product
    Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateCPSC·24132·2024-02-29

    Vernier Go Direct Charge Stations Recalled Due to Burn Hazard

    Vernier Science Education is recalling about 15,000 Go Direct Charge Stations because they can overheat and pose a burn hazard. The company has received two reports of overheating but no injuries have been reported.

    Product
    Vernier Go Direct® Charge Stations
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24134·2024-02-29

    Electric Height-Adjustable Mobile Stands for Displays Recalled for Tip-Over Hazard

    SMART Technologies is recalling about 750 electric height-adjustable mobile stands for large interactive flat panel displays because wheelbase welds can bend or break during movement, causing the stands to tip over and create entrapment hazards.

    Product
    Electric Height-Adjustable Mobile Stands for Large Interactive Flat Panel Displays
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1168-2024·2024-02-28

    W&H Surgical Handpiece S-12 Recalled for Incorrect Laser Marking

    W&H Surgical handpiece S-12 devices were incorrectly laser marked with '1:1' instead of the correct '1:2' during production. 160 units are affected.

    Product
    W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0907-2024·2024-02-28

    Psyllium Fiber Capsules Recalled Due to Illegible Labeling

    Meta Psyllium Fiber Capsules in 100 and 160 count bottles are being recalled because the product labeling is illegible. Approximately 21,428 cases were distributed across most US states.

    Product
    Meta Psyllium Fiber Capsules packaged as 100 count or 160 count PET bottles - 12 bottles per case.
    Category
    Food
    Distribution
    41 states