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.

15601–15625 of 21645

  • ModerateFDA (Food)·F-0264-2016·2015-11-25

    Ocean's Halo Seaweed Chips Recalled for Gluten Contamination

    New Frontier Foods is recalling Ocean's Halo Korean BBQ Seaweed Chips because routine tests found gluten levels above the FDA limit for gluten-free products.

    Product
    Ocean's Halo, The Seaweed Chip. Korean BBQ Flavor; 2.5 oz. bag Organic and Gluten Free ingredients. USDA Organic. Outer Case UPC: 10851899005181 Unit (Bag) UPC: 8 51899 00518 4 Distributed by New Frontier Foods, Inc. Burlingame, CA.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0317-2016·2015-11-25

    Ameditech Recalls Thermo Fisher 6 Drug Cassettes Due to Reduced Reactivity

    Ameditech is recalling Thermo Fisher 6 Drug Cassettes because they have shown reduced reactivity. The recall affects 220 units distributed in the US and Australia.

    Product
    THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0283-2016·2015-11-25

    Agfa Healthcare Recalls IMPAX CV Software for Incorrect PDF Reports

    Agfa Healthcare is recalling IMPAX CV software versions 7.8.x and 12.x because the Demographics Manager feature may generate incorrect PDF reports after physician signature.

    Product
    IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0309-2016·2015-11-25

    Ameditech Recalls DrugSmart Dip Drug Abuse Tests Due to Reduced Reactivity

    Ameditech is recalling 160 units of DrugSmart Dip drug abuse tests because they have shown reduced reactivity. The affected products were distributed in the US and Australia.

    Product
    DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0187-2016·2015-11-25

    Herr's Potato Chips Recalled for Incorrect Gluten-Free Labeling

    Herr's Foods is recalling Sour Cream & Onion Potato Chips because packaging incorrectly states the product is gluten-free, despite containing wheat.

    Product
    Herr's Sour Cream & Onion Flavored Potato Chips
    Category
    Food
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-0308-2016·2015-11-25

    Ameditech Recalls DrugSmart Drug Abuse Test Cups Due to Reduced Reactivity

    Ameditech is recalling specific DrugSmart drug abuse test cups because they have shown reduced reactivity. The affected units were distributed in the US and Australia.

    Product
    DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0314-2016·2015-11-25

    Ameditech Recalls Premier Clia Waived 12 Panel Tilt Cup Drug Tests

    Ameditech is recalling Premier Clia Waived 12 Panel Tilt Cup drug tests because they have shown reduced reactivity.

    Product
    Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0316-2016·2015-11-25

    Ameditech Recalls 6 Panel Drug Detection Cups Due to Reduced Reactivity

    Ameditech is recalling 2,240 units of 6 Panel Cup Body and Lid drug tests because they have shown reduced reactivity.

    Product
    The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0307-2016·2015-11-25

    Ameditech Recalls DrugSmart 10 Test Cups Due to Reduced Reactivity

    Ameditech is recalling DrugSmart 10 Test Cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0299-2016·2015-11-25

    Ameditech Recalls 10-Panel Pipette Drug Screen Due to Reduced Reactivity

    Ameditech is recalling 10-Panel Pipette Drug Screen tests because they have shown reduced reactivity. The recall affects 200 units distributed in the US and Australia.

    Product
    10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0263-2016·2015-11-25

    Ocean's Halo Seaweed Chips Recalled for Gluten Contamination

    New Frontier Foods is recalling Ocean's Halo Chili Lime Seaweed Chips because routine tests found gluten levels above the FDA limit for gluten-free products.

    Product
    Ocean's Halo, The Seaweed Chip. Chili Lime Flavor; 2.5 oz. bag Organic and Gluten Free ingredients. USDA Organic. Outer Case UPC: 10851899005198 Unit (Bag) UPC: 8 51899 00519 1 Distributed by New Frontier Foods, Inc. Burlingame, CA.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0188-2016·2015-11-25

    Enjoy Life Semi-Sweet Chocolate Mini Chips Recalled for Undeclared Allergens

    Enjoy Life Natural Brands is recalling Semi-Sweet Chocolate mini chips because they may contain undeclared sunflower seeds, pumpkin seeds, and dried fruit.

    Product
    Semi-Sweet Chocolate mini chips packaged in a plastic bad with yellow label and white lettering.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0305-2016·2015-11-25

    Ameditech Recalls DrugCheck Pipette 10 Drug Tests Due to Reduced Reactivity

    Ameditech is recalling 70 units of DrugCheck Pipette 10 Drug Tests because they have shown reduced reactivity. The affected tests were distributed in the US and Australia.

    Product
    DrugCheck Pipette 10 Drug Test, Item No. 41025 DC These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0235-2016·2015-11-25

    Mylan Recalls Meclizine Hydrochloride Tablets Due to Impurity Failures

    Mylan Institutional is recalling 4,609 packages of Meclizine Hydrochloride 25 mg tablets because they failed impurity specifications.

    Product
    Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0302-2016·2015-11-25

    Ameditech Recalls 12-Panel Dip Drug Screens Due to Reduced Reactivity

    Ameditech is recalling 12-Panel Dip Drug Screens with adulterant because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0266-2016·2015-11-18

    Biomet 3i Dental Driver Tips Recalled for Mislabeling

    Biomet 3i is recalling 96 dental driver tips because hexed tips were labeled as square tips, and square tips were marked with hexed identifiers.

    Product
    Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0252-2016·2015-11-18

    Biocare Medical Recalls Smooth Muscle Actin Immunohistochemistry Reagents

    Biocare Medical is recalling certain lots of Smooth Muscle Actin reagents because they may stain cell types that should be negative.

    Product
    Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the…
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0238-2016·2015-11-18

    Focus Diagnostics Recalls Anaplasma Phagocytophilum IFA IgM Test Kits

    Focus Diagnostics is recalling 38 Anaplasma phagocytophilum IFA IgM Test Kits due to a potential increase in invalid results.

    Product
    Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0233-2016·2015-11-18

    Utah Medical Recalls Myelo-Nate CSF Sampling Kits Due to Seal Compromise

    Utah Medical Products is recalling 21,403 Myelo-Nate CSF Sampling Kits because an internal inspection found a compromised sterile seal on one side of the tray.

    Product
    Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0164-2016·2015-11-18

    C. O. Truxton Recalls Doxycycline Hyclate Tablets Due to Wrong Bar Code

    C. O. Truxton is recalling 287 bottles of Doxycycline Hyclate Tablets, 100 mg, because the product bears the wrong bar code.

    Product
    Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by: Truxton Inc. Bellmawr, NJ 08031, Manufactured for: Blu Caribe Dorado, PR 00646 USA, NDC 0463-6000-50 (top panel) NDC 24658-312-05 (side panel)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0244-2016·2015-11-18

    Cook Medical CXI Support Catheters Recalled Due to Product Mixing

    Cook Inc. is recalling specific lots of CXI Support Catheters because the 2.6FR curved and 4.0FR straight catheters were mixed during processing.

    Product
    Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0232-2016·2015-11-18

    Boston Scientific SQ-RX Subcutaneous Pulse Generator Recall for Telemetry Issues

    Boston Scientific is recalling three SQ-RX Model 1010 subcutaneous pulse generators shipped in dual-channel mode. This configuration may delay initial telemetry scans but does not affect therapy delivery.

    Product
    Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0265-2016·2015-11-18

    Siemens Modularis VarioStar Lithotripter Recalled for Display Freeze Issue

    Siemens Medical Solutions is recalling 15 Modularis VarioStar lithotripters because a display freeze prevents current treatment data from being shown to users.

    Product
    MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0267-2016·2015-11-18

    Biomet 3i Dental Driver Tip Recalled for Mislabeling

    Biomet 3i is recalling 103 Narrow Right Angle Square Driver Tips that were mislabeled as hexed tips, creating a risk of improper use during dental procedures.

    Product
    Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0268-2016·2015-11-18

    Medtronic Perfusion Tubing Packs Recalled for Potential Header Bag Seal Breach

    Medtronic is recalling 496 Perfusion Tubing Packs due to a potential breach in the header bag seal. The affected lots were distributed nationwide in the US.

    Product
    Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are…
    Category
    Medical Device
    Distribution
    Distributed nationwide