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.

13926–13950 of 21617

  • ModerateFDA (Food)·F-2246-2016·2016-09-21

    Kill Cliff Strawberries & Cream Protein Bars Recalled for Potential Mold

    Kill Cliff is recalling Strawberries & Cream Protein Bars because they may contain mold. The recall started on June 21, 2016.

    Product
    KC (Kill Cliff) Strawberries & Cream Protein Bars, 2.1oz (60g) individually wrapped bar (in cases of 12-2.1 oz (60g) bars).
    Category
    Food
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-2777-2016·2016-09-21

    Integra Meshed Dermal Regeneration Template Recalled for Calculation Error

    Integra LifeSciences is recalling 14 packages of Meshed Dermal Regeneration Template due to an incorrect calculation of peel strength test results.

    Product
    Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1501-2016·2016-09-21

    Amerisource Recalls bupropion Hydrochloride Tablets for Dissolution Failure

    Amerisource Health Services is recalling 2,626 bottles of bupropion hydrochloride extended-release tablets due to failed dissolution specifications.

    Product
    buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2793-2016·2016-09-21

    Siemens Syngo Plaza PACS Recall for Measurement Display Suffix

    Siemens is recalling 101 Syngo Plaza PACS systems because a suffix on DICOM images may indicate that displayed measurements differ from actual values.

    Product
    Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2770-2016·2016-09-21

    Sysmex Fluorocell PLT Reagent Recalled for Potential Low Platelet Results

    Sysmex America Inc is recalling Fluorocell PLT reagent because it may produce falsely low platelet results on Sysmex XN-Series analyzers.

    Product
    Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2791-2016·2016-09-21

    Stryker Recalls Mislabelled T2 Supracondylar Nail System

    Stryker Howmedica Osteonics Corp. is recalling one unit of the T2 Supracondylar Nail System because it was incorrectly labeled and distributed.

    Product
    Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3)…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2794-2016·2016-09-21

    Siemens Syngo.Plaza VB 10 A PACS Recall for Measurement Suffix Display

    Siemens is recalling 101 Syngo.Plaza VB 10 A image processing systems because a suffix on DICOM images may indicate that displayed measurement values differ from real values.

    Product
    Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2255-2016·2016-09-21

    Misono Food Recalls Smoked Herring Due to HACCP Violations

    Misono Food Ltd is recalling Smoked Herring Slow Food because the foreign processor failed to meet HACCP requirements. The product was distributed to one retailer in New York City.

    Product
    Smoked Herring Slow Food (Quality: Polar Golden Presidia), Net weight 0.378 (others may vary slightly), Produced by: Njardar AS 6094 Leinoy, Product of Norway
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2773-2016·2016-09-21

    Arrow Single-Lumen Catheters Recalled for Packaging Component Molding Abnormality

    Arrow International Inc. is recalling 6,121 units of Arrow Single-Lumen Catheters due to a molding abnormality in the packaging component supplied by a vendor.

    Product
    Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2829-2016·2016-09-21

    AirStrip Sense4Baby Fetal Monitor Recalled for Detaching Belt Clip

    AirStrip Technologies is recalling 42 Sense4Baby Model C fetal monitors because the belt clip may detach, exposing electronic components.

    Product
    AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-2201-2016·2016-09-21

    Van Vogt Mill House Salad Dressing Recalled for Undeclared Sulfites

    Van Vogt Creations is recalling Mill House Salad Dressing & Gourmet Sauce due to undeclared sulfites. The product was sold at the firm's retail store in Washington.

    Product
    Mill House Salad Dressing & Gourmet Sauce 12 FL OZ Plastic Bottles Ingredients: canola oil, garlic, lemon juice, water, salt, pepper.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2772-2016·2016-09-21

    Arrow Select Kit Ultrasound Catheters Recalled for Packaging Molding Abnormality

    Arrow International Inc. is recalling 6,121 units of Arrow Select Kit ultrasound catheters due to a component molding abnormality in the packaging.

    Product
    Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2775-2016·2016-09-21

    Thermo Fisher Recalls Endura MD Mass Spectrometer Software Due to Data Accuracy Defect

    Thermo Fisher is recalling Endura MD Mass Spectrometer software versions 1.0 and 1.0 SP1 because a defect affects data accuracy.

    Product
    Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2776-2016·2016-09-21

    Biosense Webster Recalls CARTO 3 EP Navigation Systems in China

    Biosense Webster is voluntarily re-installing 338 CARTO 3 EP Navigation Systems in China, Hong Kong, and Brazil that were moved without required testing.

    Product
    CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2762-2016·2016-09-14

    Riverpoint Medical Recalls Webglo Polypropylene Surgical Sutures Due to Seal Issues

    Riverpoint Medical is recalling specific lots of Webglo polypropylene surgical sutures because the seals may open during distribution or packaging.

    Product
    Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2763-2016·2016-09-14

    Blackrock NeuroPort Biopotential Signal Processing System Recall for Labeling Error

    Blackrock Microsystems is recalling 81 Neural Signal Amplifiers because the device and patient cable are incorrectly labeled as Type CF Applied Parts.

    Product
    Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2074-2016·2016-09-14

    Nature Made Hair Skin Nails Gummies Recalled for Microbial Count

    Pharmavite is recalling specific lots of Nature Made adult gummies Hair.Skin.Nails because they may exceed specifications for total viable plate count.

    Product
    Nature Made(R) adult gummies Hair.Skin.Nails, 150 count, UPC 0-31604-04132-8-1
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2109-2016·2016-09-14

    Inland Market Dungeness Crab Cake Recalled for Wood Contamination

    Inland Seafood, Inc. is recalling Inland Market Dungeness Crab Cake due to possible contamination with wood pieces.

    Product
    Inland Market, Dungeness Crab Cake, Net Wt. 5 lbs, Inland Market, 1667 Lewis Way, Stone Mountain, GA 30083, for Whole Foods Market
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-2102-2016·2016-09-14

    Inland Market Maine Lobster Spread Recalled for Wood Contamination

    Inland Seafood, Inc. is recalling Inland Market Maine Lobster Spread due to possible contamination with wood pieces.

    Product
    Inland Market, Premium, Maine Lobster Spread, Net Wt. 7 oz. (198 g.) and 16 oz. (454g), Inland Market, 1667 Lewis Way, Stone Mountain, GA 30083.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2764-2016·2016-09-14

    Blackrock NeuroPort Patient Cables Recalled for Incorrect Labeling

    Blackrock Microsystems is voluntarily recalling 120 Patient Cables because they are incorrectly labeled as Type CF Applied Parts.

    Product
    Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2110-2016·2016-09-14

    Inland Market Traditional Crab Cake Recalled for Wood Contamination

    Inland Seafood, Inc. is recalling Inland Market Traditional Crab Cake due to possible contamination with wood pieces.

    Product
    Inland Market, Traditional Crab Cake, Net Wt. 5 lbs, Inland Market, 1667 Lewis Way, Stone Mountain, GA 30083, for Whole Foods Market
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-2103-2016·2016-09-14

    Inland Seafood Recalls Cheese Spread for Possible Wood Contamination

    Inland Seafood, Inc. is recalling Original Seafood Cheese Spread for Publix due to possible contamination with wood pieces.

    Product
    Original Seafood Cheese Spread, Net Wt. 7 oz. (198 g.), for Publix
    Category
    Food
    Distribution
    11 states