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.

10226–10250 of 21617

  • ModerateFDA (Food)·F-1714-2018·2018-08-08

    Roctane Ultra Endurance BCAA Capsules Recalled for Potential Cyclamates

    Advanced Food Concepts is recalling Roctane Ultra Endurance BCAA Capsules because testing confirmed the presence of cyclamates.

    Product
    Roctane Ultra Endurance BCAA Capsules; Branch chain amino acid capsule 60 capsule bottle, Item # 124188, UPC: 769493101488
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2567-2018·2018-08-08

    Howmedica Custom Implant System Recalled for Missing Instructions

    Howmedica is recalling five custom implant systems because they lacked updated instructions clarifying the locking mechanism and screw warnings.

    Product
    Custom Made Implant System with Minimum Invasive Grower (MIG) component
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-1708-2018·2018-08-08

    Roctane Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling Roctane Ultra Endurance Energy Gels because testing confirmed the presence of cyclamates.

    Product
    Roctane Ultra Endurance Energy Gels: Tutti Frutti Roc Gel: ROC GEL 1 Pkt, Item # 124315, UPC: 76949310247; ROC GEL 24 Pkt Box, Item # 124314, UPC: 769493102461.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2600-2018·2018-08-08

    Encore Medical Recalls AltiVate Instrument Trays Due to Coating Issue

    Encore Medical is recalling 30 instrument trays used for AltiVate Small Shell Trials because a black coating may appear after cleaning that is not biocompatible.

    Product
    Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrum
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Food)·F-1700-2018·2018-08-08

    Roctane Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling Roctane Ultra Endurance Energy Gels because testing confirmed the presence of cyclamates.

    Product
    Roctane Ultra Endurance Energy Gels: Blueberry Pomegranate, Roc Gel: ROC GEL 1 Pkt, Item # 123058, UPC: 769493105011; ROC GEL 15 Serve Pkt, Item # 124103. UPC: 769493100917; ROC GEL 24 Pkt Box, Item # 123065, UPC: 769493205018
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1688-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the product may contain cyclamates, an ingredient not listed on the label.

    Product
    GU Energy Gels: Gingerade, Gel; GUGEL 1 Pkt; item # 124297, UPC: 769493102409; GUGEL 24Pkt Box; item number 124296, UPC: 769493102393.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1696-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the presence of cyclamates, a substance not permitted in food.

    Product
    GU Energy Gels: Tastefully Nude, Gel; GUGEL 1 Pkt; item # 123835, UPC: 769493200976; GUGEL 24Pkt Box; item number 123836, UPC:769493200983.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1709-2018·2018-08-08

    Roctane Ultra Endurance Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling Roctane Ultra Endurance Energy Gels because testing confirmed the product may contain cyclamates.

    Product
    Roctane Ultra Endurance Energy Gels: Vanilla Orange Roc Gel: ROC GEL 1 Pkt, Item # 123059, UPC: 769493105028; ROC GEL 24 Pkt Box, Item # 123066, UPC:769493205025 .
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1799-2018·2018-08-08

    Sugar Foods Recalls Zesty Italian Croutons Due to Whey Powder Contamination

    Sugar Foods Corporation is recalling Zesty Italian Croutons because they were produced using recalled whey powder. The affected product was distributed in six states.

    Product
    Kitchen Fixins Zesty Italian Croutons: 5 oz. foil pouch Item # 31330 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2569-2018·2018-08-08

    Stryker FlowGate2 Balloon Guide Catheter Recalled for Diameter Defect

    Stryker Neurovascular is recalling FlowGate2 Balloon Guide Catheters because the balloon diameter may exceed specifications, potentially causing resistance during use.

    Product
    FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1686-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the presence of cyclamates, an ingredient not declared on the label.

    Product
    GU Energy Gels: Espresso Lover Gel; GUGEL 1 Pkt; item # 123021, UPC:769493100078; GUGEL 24Pkt Box; item number 123050 , UPC769493200082 .
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1719-2018·2018-08-08

    Advanced Food Concepts Recalls Waffle Products Due to Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Stroopwafels and Hoka Campfire Smores waffles because testing confirmed the presence of cyclamates.

    Product
    GU Energy Stroopwafels; Dutch-Style syrup filled waffle cookie;, Hoka Campfire Smores, Waffle; WAFFLE 1 Pkt, Item # 124513, UPC: 769493103222; WAFFLE 16 Pkt Box, Item # 124512, UPC:769493103215;
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1694-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels in Salted Watermelon flavor because testing confirmed the presence of cyclamates.

    Product
    GU Energy Gels: Salted Watermelon, Gel; GUGEL 1 Pkt; item # 123030, UPC:769493100207; GUGEL 24Pkt Box; item number 123055, UPC:769493200211.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2581-2018·2018-08-08

    GE Healthcare Recalls CT Systems with Potential Electrical Wiring Defect

    GE Healthcare is recalling 42 Discovery RT CT systems nationwide due to a potential wiring defect in the electrical panel that may affect the uninterruptible power supply.

    Product
    Discovery RT labeled as: a. MID BJG; b. HVY BJG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1018-2018·2018-08-08

    Vensun Pharmaceuticals Recalls Potassium Citrate Tablets Due to Breakage

    Vensun Pharmaceuticals is recalling 3,683 bottles of Potassium Citrate Extended-Release Tablets because they failed specifications due to tablet breakage.

    Product
    POTASSIUM CITRATE — POTASSIUM CITRATE (POTASSIUM CITRATE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1687-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels in French Toast flavor because testing confirmed the presence of cyclamates.

    Product
    GU Energy Gels: French Toast, Gel; GUGEL 1 Pkt; item # 124523, UPC:769493103239; GUGEL 24Pkt Box; item number 124528 , UPC: 769493103246 .
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1692-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels (Mint Chocolate) because testing confirmed the presence of cyclamates, a substance not permitted in food.

    Product
    GU Energy Gels: Mint Chocolate, Gel; GUGEL 1 Pkt; item # 124250, UPC:769493100108; GUGEL 24Pkt Box; item number 123943, UPC: 769493200136.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1711-2018·2018-08-08

    GU Energy Chews Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Chews because testing confirmed the presence of cyclamates, an ingredient not declared on the label.

    Product
    GU Energy Chews; Orange, Chews; CHEWS 1 Pkt, Item # 124182, UPC: 769493101457; CHEWS 18 Pkt Box, Item # 124178, UPC: 769493101419.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1693-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the presence of cyclamates, a substance not permitted in food.

    Product
    GU Energy Gels: Salted Caramel, Gel; GUGEL 1 Pkt; item # 123027, UPC:769493100184; GUGEL 8Pkt Box, Item # 123037, UPC: 769493900180; GUGEL 15 Serve Pkt, Item # 124098, UPC: 769493100863; GUGEL 24Pkt Box; item number 123041, UPC: 769493200198.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1695-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the presence of cyclamates, an ingredient not declared on the label.

    Product
    GU Energy Gels: Salted Watermelon, Gel; GUGEL 1 Pkt; item # 123030, UPC:769493100207; GUGEL 24Pkt Box; item number 123055, UPC:769493200211.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1684-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels in Caramel Macchiato flavor because testing confirmed the presence of cyclamates.

    Product
    GU Energy Gels: Caramel Macchiato, Gel; GUGEL 1 Pkt; item # 123031, UPC 769493200518; GUGEL 24Pkt Box; item number 123056, UPC 769493200525
    Category
    Food
    Distribution
    0 states