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.

10201–10225 of 21617

  • ModerateFDA (Devices)·Z-2624-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 85-inch Y-Type Blood Sets because some units are labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    85" (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2609-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2657-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 116-inch Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2647-2018·2018-08-15

    ICU Medical Recalls Blood Tubing Accessories Due to Mislabeling

    ICU Medical is recalling 160,016 units of Y-Type Admin Sets because they were labeled as not containing DEHP, though they may contain small amounts.

    Product
    134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Rotating Luer w/Filter Cap, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1718-2018·2018-08-08

    GU Energy Stroopwafels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Stroopwafels because testing confirmed the presence of cyclamates, an unapproved food additive.

    Product
    GU Energy Stroopwafels; Dutch-Style syrup filled waffle cookie; Gingerade, Waffle; WAFFLE 1 Pkt, Item # 124325, UPC:769493102522; WAFFLE 16 Pkt Box, Item # 124321, UPC:769493102492;
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1706-2018·2018-08-08

    Roctane Ultra Endurance Energy Gels Recalled for Potential Cyclamate Contamination

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

    Product
    Roctane Ultra Endurance Energy Gels: Sea Salt Chocolate, Roc Gel: ROC GEL 1 Pkt, Item # 123901, UPC: 769493201966; ROC GEL 15 Serve Pkt, Item # 124102, UPC: 769493100900; ROC GEL 24 Pkt Box, Item # 123904, UPC: 769493201959.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1715-2018·2018-08-08

    GU Energy Stroopwafels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Stroopwafels because testing confirmed the presence of cyclamates, an unapproved food additive.

    Product
    GU Energy Stroopwafels; Dutch-Style syrup filled waffle cookie; Campfire Smores, Waffle; WAFFLE 1 Pkt, Item # 124380, UPC: 769493102683; WAFFLE 16 Pkt Box, Item # 124379, UPC: 769493102676;
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1707-2018·2018-08-08

    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: Strawberry Kiwi Roc Gel: ROC GEL 1 Pkt, Item # 123063, UPC: 769493105080; ROC GEL 15 Serve Pkt, Item # 124254, UPC:769493102102; ROC GEL 24 Pkt Box, Item # 123070, UPC: .769493205094
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1673-2018·2018-08-08

    Apogee Foods Recalls Thunderbird Apple Pie Kid Bars for Temperature Issues

    Apogee Foods is recalling Thunderbird Apple Pie Kid Bars because the manufacturing process did not reach required temperatures. The product was distributed in Texas.

    Product
    Thunderbird Bars 1.15 oz Apple Pie Kid Bar (carton of 120)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1721-2018·2018-08-08

    GU Energy Stroopwafels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Stroopwafels because testing confirmed the product may contain cyclamates, an unapproved food additive.

    Product
    GU Energy Stroopwafels; Dutch-Style syrup filled waffle cookie;, Salted Chocolate GF, Waffle; WAFFLE 1 Pkt, Item # 124204, UPC: 769493101648; WAFFLE 16 Pkt Box, Item # 124200, UPC:769493101600.
    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-1702-2018·2018-08-08

    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: Cherry Lime, Roc Gel: ROC GEL 1 Pkt, Item # 123061, UPC:769493105059 ; ROC GEL 24 Pkt Box, Item # 123068, UPC: 769493205056.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1681-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

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

    Product
    GU Energy Gels: Birthday Cake, Gel; GUGEL 1 Pkt; item # 124418, UPC 769493102843; GUGEL 8Pkt Box, item number 124419, UPC: 769493102850; GUGEL 24Pkt Box; item number 124417, UPC 769493102836.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1689-2018·2018-08-08

    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 listed on the label.

    Product
    GU Energy Gels: Jet Blackberry, Gel; GUGEL 1 Pkt; item # 123022, UPC:769493100122 ; GUGEL 24Pkt Box; item number 123044, UPC: 769493200129.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1024-2018·2018-08-08

    West-Ward Recalls Doxycycline Hyclate Tablets for Dissolution Failures

    West-Ward Columbus Inc is recalling Doxycycline Hyclate 100 mg tablets because they failed to meet dissolution specifications.

    Product
    DOXYCYCLINE HYCLATE — DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1017-2018·2018-08-08

    Vensun Recalls Potassium Citrate Tablets Due to Tablet Breakage

    Vensun Pharmaceuticals is recalling 11,652 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-1682-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels (Campfire Smores) because testing confirmed the presence of cyclamates.

    Product
    GU Energy Gels: Campfire Smores, Gel; GUGEL 1 Pkt; item # 124357, UPC 769493102614; GUGEL 24Pkt Box; item number 124358, UPC 769493102621
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1712-2018·2018-08-08

    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; Strawberry Chews; CHEWS 1 Pkt, Item # 124180, UPC:769493101433 ; CHEWS 18 Pkt Box, Item # 124176, UPC:769493101396 .
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1705-2018·2018-08-08

    Roctane Ultra Endurance Energy Gels Recalled for Potential Cyclamates

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

    Product
    Roctane Ultra Endurance Energy Gels: Pineapple, Roc Gel: ROC GEL 1 Pkt, Item # 123060, UPC: 769493105035; ROC GEL 24 Pkt Box, Item # 123067, UPC: 769493205032.
    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-1720-2018·2018-08-08

    GU Energy Stroopwafels Recalled for Potential Cyclamate Contamination

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

    Product
    GU Energy Stroopwafels; Dutch-Style syrup filled waffle cookie;, Hot Chocolate, Waffle; WAFFLE 1 Pkt, Item # 124326, UPC: 769493102539; WAFFLE 16 Pkt Box, Item # 124322, UPC:769493102508;
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1691-2018·2018-08-08

    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: Mandarin Orange, Gel; GUGEL 1 Pkt; item # 123026, UPC:769493100139 ; GUGEL 24Pkt Box; item number 123043, UPC: 769493200143.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1672-2018·2018-08-08

    Apogee Foods Recalls Thunderbird Bars Due to Temperature Control Failure

    Apogee Foods is recalling Thunderbird Bars because the manufacturing process did not reach required temperatures. The recall affects 63 cases distributed in Texas.

    Product
    Thunderbird Bars 1.7 oz Pecan Goji Pistachio Bar (case of 120)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1722-2018·2018-08-08

    Advanced Food Concepts Recalls GU Energy Stroopwafels Due to Cyclamates

    Advanced Food Concepts is recalling GU Energy Stroopwafels because testing confirmed the presence of cyclamates, an unapproved food additive.

    Product
    GU Energy Stroopwafels; Dutch-Style syrup filled waffle cookie;, Salty's Caramel, Waffle; WAFFLE 1 Pkt, Item # 124205, UPC: 769493101655; WAFFLE 16 Pkt Box, Item # 124201, UPC: 769493101617.
    Category
    Food
    Distribution
    0 states