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.

14276–14300 of 21645

  • ModerateFDA (Devices)·Z-2245-2016·2016-07-27

    Siemens Syngo.via PACS Software Recalled for Incorrect Volume Calculations

    Siemens Medical Solutions is recalling 50 units of Syngo.via PACS software due to incorrect volume calculation values. A software update is available to resolve the error.

    Product
    Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1704-2016·2016-07-27

    Bolthouse Farms Recalls Protein Plus Drinks Due to Spoilage

    Bolthouse Farms is recalling 8 varieties of Protein Plus and Perfectly Protein drinks because spoilage may cause the beverages to appear lumpy and have an unpleasant taste and odor.

    Product
    Bolthouse Farms Coconut Protein Plus: 30 g protein per bottle + 21 vitamins & minerals. Packaged in 15.2 oz/450 mL item number: PPCN4BF6; Selling Unit UPC Case GTIN 15.2 oz. 0-71464-01892-4…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1671-2016·2016-07-27

    Los Mart Chicharrin Rueda Recalled for Undeclared Yellow #6

    Martinez Imports is recalling Los Mart Chicharrin Rueda because sampling revealed the product contains undeclared Yellow #6.

    Product
    Los Mart Chicharrin Rueda, 1 lb, Packaged & Distributed by Martinez Imports, 1 Market St. Bldg. #6, Passaic, NJ 07055
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1674-2016·2016-07-27

    Martinez Imports Recalls Los Mart Chicharrin Lagrima for Undeclared Yellow #6

    Martinez Imports is recalling 14 cases of Los Mart Chicharrin Lagrima found in New York because testing revealed the presence of undeclared Yellow #6.

    Product
    Los Mart Chicharrin Lagrima (Palmex Rotini), 1 lb., Package & Distributed by Martinez Imports, 1 Market St., Bldg #6, Passaic, NJ 07055
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1703-2016·2016-07-27

    Bolthouse Farms Recalls Protein Plus Drinks Due to Spoilage

    Bolthouse Farms is recalling 8 varieties of Protein Plus and Perfectly Protein drinks because spoilage may cause the beverages to appear lumpy and have an unpleasant taste and odor.

    Product
    Bolthouse Farms Coffee Protein Plus: 30 g protein per bottle + 21 vitamins & minerals. Packaged in 11 oz./325 mL - item number PPJ3BF9; 15.2 oz/450 mL item number: PPJ4BF6; 32 oz./946 mL; item number PPJQBF6: Selling Unit UPC…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1672-2016·2016-07-27

    Los Mart Chicharrin Cuadro Recalled for Undeclared Yellow #6

    Martinez Imports is recalling Los Mart Chicharrin Cuadro because testing revealed the product contains undeclared Yellow #6.

    Product
    Los Mart Chicharrin Cuadro, 1 lb., Packaged & Distributed by Martinez Imports, 1 Market St, Bldg #6, Passaic, NJ 07055
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2256-2016·2016-07-27

    Siemens ADVIA Centaur XPT Software Recalled for Potential Result Errors

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur XPT system software versions V1.0.1 through V1.1 due to eight identified issues that may affect test results.

    Product
    ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1673-2016·2016-07-27

    Los Mart Palmex Tornillo Wheat Flour Snack Recalled for Undeclared Yellow #6

    Martinez Imports is recalling Los Mart Palmex Tornillo wheat flour snacks because sampling revealed undeclared Yellow #6 dye.

    Product
    Los Mart Palmex Tornillo (Wheat Flour Snack), 1 lb., Packaged & Distributed by Martinez Imports, 1 Market St., Bldg #6, Passaic, NJ 07055
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2210-2016·2016-07-27

    Terumo Sarns Dual Cooler-Heater Recalled Due to Missing Sanitizer

    Terumo CVS is voluntarily recalling Sarns Dual Cooler-Heater devices because the distributor no longer sells the Inter chlor sanitizer required for cleaning.

    Product
    Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero…
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-2252-2016·2016-07-27

    BD Trucount Tubes Recalled for Potential Sealing Defects

    Becton, Dickinson and Company is recalling one lot of BD Trucount Absolute Counting Tubes because they may not be sealed properly, which can degrade product performance.

    Product
    BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2225-2016·2016-07-27

    WalkMed Recalls IV Administration Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling specific IV administration sets due to the potential presence of particulate matter in or on the devices.

    Product
    T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2241-2016·2016-07-27

    CSL Behring Recalls Dimension Vista Homocysteine Reagent Cartridges

    CSL Behring is recalling 898 units of Dimension Vista Homocysteine Flex Reagent Cartridges because opened lots show reduced stability and do not meet the 7-day claim.

    Product
    Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-2239-2016·2016-07-27

    Hologic Recalls ATEC Suction Canisters Due to Cracked Lids

    Hologic is recalling 16,870 ATEC Suction Canisters because the lids may crack. These devices are used to collect fluid during breast biopsies.

    Product
    ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-2220-2016·2016-07-27

    WalkMed Infusion Pumps Recalled for Unapproved Software and Specification Changes

    WalkMed Infusion is recalling Triton and Triton FP infusion pumps due to unapproved changes to software, specifications, and intended use.

    Product
    The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1705-2016·2016-07-27

    Bolthouse Farms Recalls Protein Plus Drinks Due to Spoilage

    Bolthouse Farms is recalling eight varieties of Protein Plus and Perfectly Protein drinks because spoilage may cause the beverages to appear lumpy and have an unpleasant taste and odor.

    Product
    Bolthouse Farms Strawberry Protein Plus: 30 g protein per bottle + 21 vitamins & minerals. Packaged in 15.2 oz/450 mL item number: PPCN4BF6; 32 oz/946 mL. - item number PPSWQBF6 Selling Unit UPC Case GTIN 15.2 oz.…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2214-2016·2016-07-27

    DePuy Synthes Recalls TFNA Blade/Screw Guide Sleeves Due to Sizing Defect

    DePuy Synthes is voluntarily recalling TFNA Blade/Screw Guide Sleeves because a manufacturing defect may prevent proper use, potentially causing surgical delays.

    Product
    Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, Class I exempt Lot Numbers: 9066399; 9066435; 9409790; 9519308; 9620447; 9301183; 9409792; 9519303; 9641077; 9301184; 9409791; 9542998…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2188-2016·2016-07-27

    Toshiba Angio WorkStation Recalled for Incorrect Skin Dose Calculation

    Toshiba is recalling 23 Angio WorkStation systems because a software error caused the displayed Peak Skin Dose to be higher than expected during specific procedures.

    Product
    Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2208-2016·2016-07-27

    Terumo Recalls Sarns Temperature Control Units Due to Sanitizer Discontinuation

    Terumo CVS is voluntarily recalling Sarns TCM units because the Interchlor sanitizer referenced in cleaning instructions is no longer sold by the distributor.

    Product
    Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient The TCM with options will also supply water for…
    Category
    Medical Device
    Distribution
    51 states
  • ModerateUSDA FSIS·063-2016·2016-07-22

    House of Smoke Recalls Wild Boar Brotwurst Due to High Nitrite Levels

    House of Smoke is recalling approximately 4,692 pounds of Wild Boar Brotwurst because nitrite levels exceeded regulatory limits. No adverse reactions have been reported.

    Product
    House Of Smoke, Inc. — House of Smoke Recalls Products Due To Nitrite Levels in Excess of Regulatory Limit
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1351-2016·2016-07-20

    FDA Recalls Laryngitis Pills Marketed Without Approval

    Murray International Trading Co. is recalling Laryngitis Pills Herbal Supplement because it is marketed as a dietary supplement but bears drug claims, making it an unapproved drug.

    Product
    LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3 tubes per packet within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd.; Imported by: Murray Int'l Trading Co., Inc., New York, NY 10013; UPC 7 67533 86925 1, remaining labeling contains…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2190-2016·2016-07-20

    Synthes Recalls Neuro Screwdriver Blades for Incorrect MR Safety Labeling

    Synthes (USA) Products LLC is recalling 26 neuro screwdriver blades because their MR safety labels do not meet current ASTM standards.

    Product
    Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2202-2016·2016-07-20

    Arrow Femoral Arterial Line Catheterization Kit Recalled for Labeling Error

    Arrow International Inc. is recalling 50 units of Femoral Arterial Line Catheterization Kits due to shipping carton labeling errors.

    Product
    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1357-2016·2016-07-20

    FDA Recalls Te Xiao BaiNeiTing Herbal Supplement for Unapproved Drug Claims

    Murray International Trading Co. is recalling 17 boxes of Te Xiao BaiNeiTing Herbal Supplement because the product is marketed with drug claims without an approved NDA or ANDA.

    Product
    Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, Net Wt. 15ml, packaged in a bottle within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd, Imported by Murray Int'l Trading Co., Inc. New York, NY 10013, UPC 7 67533 86115 6, remaining…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2152-2016·2016-07-20

    Synthes 6.5 mm Cannulated Screw Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 6.5 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2198-2016·2016-07-20

    Synthes Recalls 2.0mm Stardrive Screwdriver for Incorrect MR Safety Labeling

    Synthes (USA) Products LLC is recalling 36 units of 2.0mm Stardrive Screwdrivers because their MR safety labeling does not meet current ASTM standards.

    Product
    Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide