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.

19951–19975 of 21633

  • ModerateFDA (Food)·F-1933-2013·2013-10-02

    Healthmaxx Global Recalls Mislabelled Dietary Supplements

    Healthmaxx Global Inc. is voluntarily recalling MAX LUNG AID and MAX POMEGRANATE dietary supplements due to mislabeling of product names and ingredients.

    Product
    Dietary Supplements Under the Same Formulation, Labeled and Packaged as the following: MAX LUNG AID, 100 Count Capsules; MAX Brand POMEGRANATE, 100 Count Capsules. Product labeling reads in part:"MAX LUNG AID Extra Strength Dietary Supplement 100 CAPSULES***0 65176 26289…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2281-2013·2013-10-02

    CareFusion Recalls Gravity Sets Due to Incorrect Expiration Date Labeling

    CareFusion is recalling 2,850 units of Gravity Set Model 44000-07 because they are labeled with a 5-year expiration date instead of the correct 3-year date.

    Product
    CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateNHTSA·13V463000·2013-09-26

    GM Recalls 2013-2014 Chevrolet Camaro Coupes for Air Bag Label Defect

    General Motors is recalling 2013-2014 Chevrolet Camaro Coupes because the air bag warning label on the sun visor may peel off, potentially leaving occupants unaware of air bag risks.

    Product
    CHEVROLET — CHEVROLET CAMARO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2204-2013·2013-09-25

    Camlog USA Recalls Uncleared Dental Implant Abutments in Four States

    Camlog USA is recalling one unit of a CONELOG Titanium Base dental implant abutment because it was not cleared for sale or use in the United States.

    Product
    C2244.3820;, CONELOG Titanium Base CC ¿3.8GH2.0 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2259-2013·2013-09-25

    Kerr Recalls NX3 Try-In Gel Due to Material Mismatch

    Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel because some syringes contain a different material than the labeled shade.

    Product
    NX3 Try-In Gel. The product is used as a tooth shade resin material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2207-2013·2013-09-25

    Biomet 3i Recalls Dental Implants Lacking Internal Hex and Thread Features

    Biomet 3i is recalling 215 Osseotite 2 Certain Prevail dental implants because some units lack the internal hex and thread features required for proper prosthetic attachment.

    Product
    Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2206-2013·2013-09-25

    Camlog USA Recalls Uncleared Dental Implant Abutments

    Camlog USA is recalling three units of CONELOG Titanbasis CAD/CAM titanium base abutments because the product was not cleared for sale or use in the United States.

    Product
    C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only ¿5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2203-2013·2013-09-25

    Camlog USA Recalls Uncleared Dental Implant Abutments in Four States

    Camlog USA is recalling two units of CONELOG Titanium Base CC dental implant abutments because the product was not cleared for sale or use in the United States.

    Product
    C2244.3808, CONELOG Titanium Base CC ¿3.8GH0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-1883-2013·2013-09-25

    New Dream Team Recalls Fresh Basil Due to Pesticide Violations

    New Dream Team is recalling fresh sweet and Thai basil from Hawaii after state testing found pesticides not allowed on the crop.

    Product
    Fresh Basil (Sweet Hawaiian and Thai) New Dream Team Inc. HI
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2258-2013·2013-09-25

    Spine Smith VisuALIF PEEK Block Recall Due to Potential Sizing Mislabeling

    Spine Smith Holdings is recalling 32 VisuALIF PEEK blocks because they may be marked as Medium when they are actually Small.

    Product
    VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2198-2013·2013-09-25

    Assuramed Recalls ProTime Microcoagulation System Cuvettes Due to Storage Issues

    Assuramed is recalling ProTime and ProTime3 cuvettes because they may have been stored at incorrect temperatures, potentially affecting test accuracy.

    Product
    ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2211-2013·2013-09-25

    Implantech Recalls Terino Square Chin-Style II-Medium Implants

    Implantech Associates Inc is voluntarily recalling 8 units of Terino Square Chin-Style II-Medium implants because they do not meet dimensional requirements.

    Product
    Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2208-2013·2013-09-25

    Biomet 3i Recalls Dental Implants Lacking Internal Hex and Thread Features

    Biomet 3i, LLC is recalling 178 Osseotite Parallel Walled dental implants because some units are missing the internal hex and internal thread features.

    Product
    Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2197-2013·2013-09-25

    Assuramed Recalls Hemoccult II SENSA elite Fecal Occult Blood Test Kits

    Assuramed is recalling Hemoccult II SENSA elite test kits because they may have been stored at temperatures outside required conditions.

    Product
    Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2218-2013·2013-09-25

    Smith & Nephew Recalls Bioraptor Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling Bioraptor 2.9 mm Suture Anchors because pinholes in the primary pouches may breach the sterile barrier.

    Product
    BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2253-2013·2013-09-25

    GE Healthcare Recalls Discovery IGS 730 X-Ray Systems for Boot Failure

    GE Healthcare is recalling four Discovery IGS 730 Cardiovascular X-Ray Imaging Systems due to a software error that may prevent the system from booting.

    Product
    GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1056-2013·2013-09-25

    Vicks NyQuil Liquid Recalled for Incorrect Undeclared Excipients Labeling

    Procter & Gamble is recalling Vicks NyQuil Cold and Flu Nighttime Relief Liquid Twin Packs because the outer wrap incorrectly identifies color additives.

    Product
    Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, Dextromethorphan HBr 30mg, Doxylamine succinate 12.5mg), 12 fl oz (354 ml) bottles, Distributed by Procter & Gamble, Cincinnati, OH 45202, NDC 37000-807-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2205-2013·2013-09-25

    Camlog Dental Implant Abutments Recalled for Lack of FDA Clearance

    Camlog USA is recalling six dental implant abutments because they were not cleared for sale or use in the United States.

    Product
    C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2254-2013·2013-09-25

    Access Scientific Recalls Mislabeled POWERWAND Safety Introducer Catheters

    Access Scientific is recalling 160 units of the POWERWAND Safety Introducer with Extended Dwell Catheter because the product is mislabeled.

    Product
    POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2212-2013·2013-09-25

    Zeppessis Reprocessed Manifolds Recalled for Lack of FDA Clearance

    Zeppessis Reprocessing is recalling reprocessed single-use manifolds for Stryker Neptune systems because they lack FDA 510(k) clearance and a validated cleaning protocol.

    Product
    Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2260-2013·2013-09-25

    Integra Recalls Cranial Access Kits Due to Potential Sterile Seal Compromise

    Integra LifeSciences is recalling specific lots of Cranial Access Kits because the sterile package seal may become compromised during shipping.

    Product
    Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2209-2013·2013-09-25

    Cincinnati Sub-Zero Blanketrol III Manuals Recalled for Labeling Error

    Cincinnati Sub-Zero is recalling Blanketrol III manuals because text was incorrectly added back, contradicting the device's approved intended use.

    Product
    Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.
    Category
    Medical Device
    Distribution
    41 states
  • ModerateFDA (Devices)·Z-2202-2013·2013-09-25

    Sonogage EyeScan A-Scan Biometer Recalled for Lack of FDA Clearance

    Sonogage Inc is recalling 564 EyeScan A-Scan Biometers because the firm lacked FDA registration and 510(k) clearance for the device.

    Product
    Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
    Category
    Medical Device
    Distribution
    Distributed nationwide