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.

901–925 of 3531

  • ModerateFDA (Devices)·Z-1414-2024·2024-04-10

    Exactech Equinoxe Shoulder Components Recalled for Nonconforming Packaging

    Exactech is recalling 3,436 units of shoulder arthroplasty components due to nonconforming packaging that lacks a required oxygen barrier layer. The products may not be adequately protected against oxidative degradation.

    Product
    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1404-2024·2024-04-10

    Exactech Shoulder Implant Components Recalled for Nonconforming Oxygen Barrier Packaging

    Exactech Inc. is recalling 6,678 shoulder glenoid implant components because they were packaged in vacuum bags lacking the required oxygen barrier layer made of Ethylene Vinyl Alcohol (EVOH).

    Product
    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1461-2024·2024-04-10

    Halyard surgical hood mislabeled as surgical cap at dispenser

    O&M Halyard is recalling approximately 75,000 surgical hoods mislabeled as surgical caps at the dispenser level.

    Product
    HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1117-2024·2024-04-10

    Waiakea Hawaiian Volcanic Water Recalled for Floating Particle Complaints

    Waiakea Hawaiian Volcanic Water is being recalled due to consumer complaints of floating particles. The recall affects 3,850 cases distributed to nine U.S. states.

    Product
    Waiakea Hawaiian Volcanic Water Naturally Alkaline Electrolytes Deep Well Water 1.0 Liter (33.8 FL OZ) Distributed by Waiakea Inc. PO Box 1595 Hilo, HI 96721 UPC 8 56652 00600
    Category
    Food
    Distribution
    9 states
  • ModerateCPSC·24182·2024-04-04

    Thule RideAlong Rear-Mounted Child Bike Seats Recalled for Chemical Hazard

    Thule is recalling about 8,640 RideAlong rear-mounted child bike seats because the harness padding can contain DecaBDE, a flame retardant, in excess of regulatory limits. DecaBDE can be toxic if ingested or if it contacts skin or eyes.

    Product
    Thule RideAlong rear-mounted Child Bike Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24183·2024-04-04

    Children's Two-Piece Pajamas and Lounge Dresses Flammability Violation Recall

    Koala Tree Enterprises (DBA Lovey & Grink) is recalling approximately 23,720 children's two-piece pajamas and lounge dresses because they violate federal flammability regulations for children's sleepwear and pose a risk of burn injuries.

    Product
    Children's Two-Piece Pajamas and Lounge Dresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0427-2024·2024-04-03

    FDA Recalls VCF Contraceptive Film Due to Manufacturing Process Violations

    The FDA is recalling VCF Contraceptive Film due to manufacturing process deviations. Apothecus Pharmaceutical Corp. initiated the voluntary recall on March 21, 2024, affecting 17,280 cartons distributed nationwide.

    Product
    VCF CONTRACEPTIVE — VCF CONTRACEPTIVE (NONOXYNOL-9)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1102-2024·2024-04-03

    Sunflour Bakery Marzipan Coffee Cake Recalled for Undeclared Yellow #5

    NRS Enterprises, Inc. dba Sunflour Bakery is recalling Marzipan/Almond Coffee Cake because Yellow #5 was not declared on the label. The product was distributed in California.

    Product
    Marzipan/Almond Coffee Cake, 16 oz, in clear poly bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1386-2024·2024-04-03

    Philips Patient Information Center Custom Ringtones Fail When Screen Locked

    Philips Patient Information Center iX running software version 4.X may not play custom ringtones when iOS screens are locked with a passcode. Approximately 257,183 units have been distributed worldwide. No injuries have been reported.

    Product
    Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1104-2024·2024-04-03

    FDA Recalls German Home Bakery Cherry Coffee Cake for Undeclared Yellow #5

    NRS Enterprises, Inc. is recalling German Home Bakery Cherry Coffee Cake due to undeclared Yellow #5. The product was distributed in California and may affect consumers with tartrazine sensitivity.

    Product
    German Home Bakery Cherry Coffee Cake, 16 oz, clear poly bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1387-2024·2024-04-03

    CareEvent Event Management System notification failure on locked iOS devices

    The CareEvent Event Management System's Care Assist mobile application fails to play custom ringtones when iOS device screens are locked with a passcode. This may result in missed alerts or notifications.

    Product
    CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1105-2024·2024-04-03

    Coffee cake recalled for undeclared Yellow #5 food dye

    Sunflour Bakery is recalling German Home Bakery Raspberry Coffee Cake due to undeclared Yellow #5 dye. The voluntary Class II recall affects 70 loaves distributed in California.

    Product
    German Home Bakery Raspberry Coffee Cake, 16 oz, clear poly bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1125-2024·2024-04-03

    Dietary Supplement Recall: TestoFREAK Contains Sub-Potent Zinc Levels

    VRA Formulations is recalling TestoFREAK Maximize Testosterone Dietary Supplement due to sub-potent zinc content. Affected bottles were distributed domestically through internet sales.

    Product
    TestoFREAK Maximize Testosterone Dietary Supplement 60 capsules per dark amber bottle, 100 bottles per case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1097-2024·2024-04-03

    Bluebonnet Methylfolate Chewables Recalled for Label Unit Error

    Bluebonnet Nutrition is recalling EarthSweet Chewables CellularActive Methylfolate 1000 mcg due to a labeling error stating '1000 mg' instead of '1000 mcg' on the front label.

    Product
    EarthSweet¿ Chewables CellularActive¿ Methylfolate 1000 mcg; 90 chewable tablets packaged in an amber glass botte with purple lid
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1376-2024·2024-04-03

    Access Substrate Reagent Bottles Recalled for Missing Product Labels

    Beckman Coulter is recalling Access Substrate reagent bottles (REF 81906) due to missing product labels on certain manufacturing lots. While the missing labels may delay patient test result reporting, no incorrect results have been reported.

    Product
    Access Substrate, REF 81906, For use with the Access Immunoassay Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1363-2024·2024-04-03

    Thermalon Neck Wrap recalled due to potential mold and mildew growth

    Bruder Healthcare Company is recalling Thermalon Neck Wrap (Item Number 24322) from certain lots due to potential mold and mildew growth from excessive moisture exposure. Consumers should discontinue use and contact the manufacturer.

    Product
    Thermalon Neck Wrap, Item Number 24322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1364-2024·2024-04-03

    Thermalon Heating Pads Recalled for Potential Mold and Mildew Growth

    Bruder Healthcare recalls Thermalon Heating Pad model 24002 due to potential mold and mildew growth from moisture exposure. Affected units were distributed nationwide in the US and to Canada.

    Product
    Thermalon Heating Pad, Item Number 24002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1106-2024·2024-04-03

    Food Recall: German Home Bakery Poppy Coffee Cake for Undeclared Yellow #5

    NRS Enterprises, Inc. (Sunflour Bakery) recalled 197 loaves of German Home Bakery Poppy Coffee Cake due to undeclared Yellow #5 dye. The product was distributed in California.

    Product
    German Home Bakery Poppy Coffee Cake, 16 oz, clear poly bag
    Category
    Food
    Distribution
    1 state
  • ModerateNHTSA·22V039000·2024-04-01

    2020-2021 Grand Design Imagine Trailers Recalled for Sharp Cabinet Handles

    Grand Design is recalling 2020-2021 Imagine travel trailers with cast aluminum cabinet handles that may have sharp edges. The sharp edges could cut or scrape occupants, and dealers will replace the handles free of charge.

    Product
    GRAND DESIGN — 2020 GRAND DESIGN IMAGINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·24176·2024-03-28

    Purefog High Density Natural Fog Juice Liquid Recalled for Mold Risk

    Pure Brands of California is recalling Purefog High Density Natural Fog Juice Liquid because the product can expire sooner than the printed expiration date, posing a mold-exposure risk to people with compromised immune systems, damaged lungs, or mold allergies.

    Product
    Purefog High Density Natural Fog Juice Liquids
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1335-2024·2024-03-27

    Angiodynamics Guidewire Introducer Devices Recalled for Manufacturing Defects

    Angiodynamics recalls MINI STICK MAX guidewire introducer devices due to manufacturing defects in the internal lumen that may prevent guidewire passage and delay surgical procedures.

    Product
    MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1311-2024·2024-03-27

    Sekisui OSOM BVBLUE Bacterial Vaginosis Control Kit recalled due to temperature exposure

    A Sekisui Diagnostics control kit for bacterial vaginosis testing was recalled after exposure to temperatures below the validated storage range for up to 60 minutes due to refrigerator mechanical failure.

    Product
    Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1338-2024·2024-03-27

    Vascular Guidewire Introducer Sheath Recall Due to Manufacturing Defect

    Angiodynamics is recalling certain MINI STICK MAX vascular guidewire introducer sheaths due to internal voids that may prevent guidewire passage during surgery, potentially causing procedural delays.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1328-2024·2024-03-27

    Liquid Protein Calibrators recalled for reference material realignment correction

    Randox Laboratories is recalling 1,764 units of Liquid Protein Calibrators used in immunoassays due to realignment of C3 and Haptoglobin to the correct reference material standard. Distribution was limited to seven U.S. states.

    Product
    Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1305-2024·2024-03-27

    Conductive Adhesive Gel Recalled Due to Thickness and Discoloration Issues

    Natus Neurology is recalling TENSIVE Conductive Adhesive Gel (Lot A0623009) after complaints of improper thickness, discoloration, and in one case, patient skin irritation following use.

    Product
    TENSIVE Conductive Adhesive Gel, REF 016-401600
    Category
    Medical Device
    Distribution
    Distributed nationwide