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.

19501–19525 of 21751

  • ModerateFDA (Devices)·Z-0562-2014·2014-01-01

    Ziehm Vista C-Arm X-Ray Systems Recalled for Emergency Switch Change

    Ziehm Imaging Inc is recalling 83 Vista and Vista Plus C-Arm X-Ray systems because an engineering change made the emergency switch an option rather than a standard component.

    Product
    Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-385-2014·2014-01-01

    Amedra Recalls Dexedrine Capsules Due to Dissolution Test Failures

    Amedra Pharmaceuticals is recalling 10,992 bottles of Dexedrine Spansules 15mg due to failed dissolution specifications at the 32-month stability level.

    Product
    Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1140-2014·2014-01-01

    Vega Sport Protein Powder Recalled for Chloramphenicol Contamination

    Sequel Naturals is recalling nine lots of Vega Sport Performance Protein Powder due to trace amounts of chloramphenicol.

    Product
    Vega Sport Performance Protein Dietary Supplement Chocolate Powder. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch. 29oz/822g, 1.3 oz/36g, 17x1.3oz/36g pouches.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0554-2014·2014-01-01

    SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect

    SpineFrontier, Inc. is recalling 25 PedFuse Screw Inserters because they may not mate properly with the hex interface of the screws.

    Product
    PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0573-2014·2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling 993 Indus Invue screws used in cervical spine surgery because they are mismarked or unmarked.

    Product
    Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1136-2014·2014-01-01

    FoodState Recalls Enzyme Supplements Due to Chloramphenicol Contamination Risk

    FoodState is recalling Innate Response Gluten and Dairy Ultra Shield Enzymes due to potential chloramphenicol contamination. Consumers should stop using the product and return it to the place of purchase.

    Product
    Innate Response Gluten and Dairy Ultra Shield Enzymes 60ct. (40127)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0574-2014·2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling 922 Indus Invue Screws because they are mismarked or unmarked. These screws are used to secure anterior cervical plates.

    Product
    Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0768-2014·2013-12-25

    National Enzyme Recalls Carbgestkosh Capsules Due to Chloramphenicol Contamination

    National Enzyme Co is recalling bulk Carbgestkosh capsules because they may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Bulk 9809 ENZYMEDICA CARBGESTKOSH capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0496-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Shelf-Life Labeling Errors

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with 'use by' dates exceeding available shelf-life data.

    Product
    Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0546-2014·2013-12-25

    Arrow International Recalls Nerve Block Catheter Kits Due to Labeling Error

    Arrow International is recalling 121 Continuous Peripheral Nerve Block Catheter Kits because the packaging incorrectly describes the stimulator cable connector.

    Product
    Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1108-2014·2013-12-25

    Lsg Food World Recalls Noodles House Home Style Noodles for Unapproved Additives

    Lsg Food World Inc. is recalling Noodles House Home Style Noodles due to the use of an unapproved color and an undeclared food additive.

    Product
    NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 900 g (31.7 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 949682 801748; Manufactured by: S&M(HK) ENTERPRISE LTD. RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: S&M INT'L…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0785-2014·2013-12-25

    National Enzyme Recalls Dietary Supplements Due to Chloramphenicol Contamination

    National Enzyme Co is recalling specific dietary supplements because a raw material may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Dietary Supplements packaged in the following configuration: (1) NEC Healthy Pre Menopausal, Feminine Support for Active Women, packaged in 60-capsule bottles (SKU 54389). Firm name on the label is National Enzyme Company, Forsyth, MO; (2) Root 86, Healthy Pre Menopausal…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0746-2014·2013-12-25

    National Enzyme Co Recalls Dietary Supplements Due to Chloramphenicol Contamination

    National Enzyme Co is recalling specific dietary supplements because they may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Dietary Supplement packaged in the following configurations: (1) 5357 NWC UltraEnzSup 90' packaged in 90 count capsule unlabeled bottles (SKU 50027); (2) 5357 NWC UltraEnzSup UNL 200 packaged in 200 count capsule unlabeled bottles (SKU 50028); (3) NWC Naturals Ultra Enzyme…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1107-2014·2013-12-25

    LSG Food World Recalls Noodles House Noodles for Unapproved Additives

    LSG Food World Inc. is recalling Noodles House Home Style Noodles due to the use of an unapproved color and an undeclared food additive.

    Product
    NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 912 g (32 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 949682 801724; *1st label indicates: Manufactured by: JINYYIFAN(HK)INTERNATIONAL LIMITED RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0744-2014·2013-12-25

    National Enzyme Recalls Blue-Green Algae Supplements Due to Chloramphenicol

    National Enzyme Co is recalling Applied Health blue-green algae supplements because they may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Applied Health, Solutions for Life, Foundation Blue-Green Algae, Detoxify and Regenerate Energy and Immune Booster, Daily Essential Nutrients packaged in 90-capsule bottles (SKU 53623). Firm name on the label is Applied Health Solutions, Scottsdale, AZ.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0810-2014·2013-12-25

    National Enzyme Recalls PerformanceZyme Supplements Due to Chloramphenicol Contamination

    National Enzyme Co is recalling PerformanceZyme dietary supplements because a raw material may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    PerformanceZyme, packaged 250-capsule bottles (SKU 54825) and 120-capsule bottles (SKU 54826). Norwegian label;
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0548-2014·2013-12-25

    Qualigen Recalls FastPack Testosterone Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 18 FastPack Testosterone Immunoassay kits because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended…
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Food)·F-0834-2014·2013-12-25

    Nature's Way Multivitamin Recalled for Potential Chloramphenicol Contamination

    Schwabe North America is voluntarily recalling Nature's Way Alive Whole Food Energizer Multivitamin because raw material enzymes may contain the antibiotic chloramphenicol.

    Product
    Nature's Way,UPC 33674150924, Alive Whole Food Energizer MultiVitamin ( No Iron Added), 90 Vcaps, 20009818
    Category
    Food
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0505-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0771-2014·2013-12-25

    National Enzyme Recalls Bulk Dige Capsules Due to Chloramphenicol

    National Enzyme Co is recalling bulk Dige capsules because they may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Bulk 9896 BIOMEDICALRESEARCH DIGE capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92115).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0509-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0511-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0752-2014·2013-12-25

    National Enzyme Recalls Dietary Supplements Due to Potential Chloramphenicol Contamination

    National Enzyme Co is recalling specific dietary supplements because they may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Dietary Supplements packaged in the following configurations: (1) Healthy Reflections, Amylase Amylolytic Enzymes Dietary Supplement, packaged in 90-capsule bottles (SKU 52896). Firm name on the label is Healthy Reflections a division of Healthy Alternatives, Garfield, MN…
    Category
    Food
    Distribution
    Distributed nationwide