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.

10326–10350 of 21617

  • ModerateFDA (Devices)·Z-2423-2018·2018-07-18

    Anika Hyalomatrix Wound Dressings Recalled for Packaging Degradation

    Anika Therapeutics is recalling Hyalomatrix wound dressings because PVC in the packaging degraded during sterilization, potentially compromising product integrity.

    Product
    Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1622-2018·2018-07-18

    Sparkling ICE Cherry Limeade Recalled for Off-Taste and Off-Odor Complaints

    Talking Rain Beverage Co Inc is recalling Sparkling ICE Cherry Limeade after customer complaints reported off-taste and off-odor.

    Product
    Sparkling ICE Cherry Limeade Naturally Flavored Sparking Water, packaged in a PET bottles with a plastic cap, Net Wt. 17 ounces (502.8 ml). UPC code on bottle: 0 16571 95084 2. UPC on Single Pack Wrapper (1 flavor/12 bottles): 016571953126 UPC on Single Pack Wrapper (1 flavo
    Category
    Food
    Distribution
    36 states
  • ModerateFDA (Drugs)·D-0917-2018·2018-07-18

    Medgyn Recalls Monsel's Solution for Manufacturing Practice Deviations

    Medgyn Products, Inc. is recalling 2,750 boxes of Monsel's Solution because the product was not manufactured under current good manufacturing practices.

    Product
    Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, C
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1614-2018·2018-07-18

    Blue Bell Vanilla Ice Cream Cups Recalled for Missing Allergen Labeling

    Blue Bell Creameries is recalling 136 boxes of 3-ounce vanilla ice cream cups because they were distributed for retail sale without required nutrition and allergen labels.

    Product
    Blue Bell Ice Cream, Brand Homemade Vanilla Flavored, 3 FL OZ (88 mL), Cups, 24 per box, This Unit Not Labeled For Retail Sale
    Category
    Food
    Distribution
    7 states
  • ModerateNHTSA·18V468000·2018-07-13

    Forest River Recalls 2019 Palomino Campers Due to Incorrect Weight Label

    Forest River is recalling 2019 Palomino hardside truck campers because the Federal Placard lists an incorrect dry weight, which may result in the vehicle being overloaded.

    Product
    FOREST RIVER — FOREST RIVER PALOMINO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2336-2018·2018-07-11

    Arrow International Recalls Multi-Lumen Central Venous Catheter Sets

    Arrow International is recalling 1,200 multi-lumen central venous catheter sets due to increased resistance during insertion, which may cause procedural delays.

    Product
    Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2335-2018·2018-07-11

    St Jude Medical Recalls Merlin PCS Programmer Software for ICM Battery Display Error

    St Jude Medical is recalling Merlin PCS Programmer Software to address an incorrect low battery indicator on Confirm Rx ICM devices caused by supply chain temperature exposure.

    Product
    Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2334-2018·2018-07-11

    St. Jude Medical Confirm Rx Insertable Cardiac Monitor Recall

    St. Jude Medical is recalling 986 Confirm Rx Insertable Cardiac Monitors because exposure to sub-freezing temperatures caused a transient battery voltage drop, resulting in an incorrect low battery indicator display.

    Product
    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2360-2018·2018-07-11

    Biocare Medical Recalls Vulcan Fast Red Chromogen Kit Due to Stability Issue

    Biocare Medical is recalling Vulcan Fast Red Chromogen Kit 2 because a stability issue in the buffer prevents the chromogen from developing.

    Product
    Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Food)·F-1606-2018·2018-07-11

    Icelandic Provisions Recalls Vanilla Skyr Cups Due to Coconut Mislabeling

    Icelandic Provisions Inc. is recalling Vanilla Skyr cups that may contain coconut skyr yogurt. The recall addresses a labeling error regarding the product flavor.

    Product
    Icelandic Provisions Vanilla Skyr cups, 5.3oz package, UPC: 854074006068
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2344-2018·2018-07-11

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products PHYT Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides due to a potential for imprecise results in quality control and patient samples.

    Product
    VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2376-2018·2018-07-11

    Implant Direct Sybron Recalls Out-of-Specification Dental Abutments

    Implant Direct Sybron is recalling 60 REPLANT 5.0mmD Abutments because they are out of specification and cannot be properly fitted to implants.

    Product
    REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Drugs)·D-0908-2018·2018-07-11

    Eb5 Age Spot Treatment Cream Recalled for Stability Failures

    Eb5 Corporation is recalling 4,632 tubes of Age Spot Treatment Cream because the product failed stability specifications for viscosity, pH, and specific gravity.

    Product
    eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Code: 7 41099 00009 9
    Category
    Drug
    Distribution
    0 states
  • ModerateNHTSA·18V448000·2018-07-05

    Keystone Recalls 2018-2019 Dutchmen Aerolite Trailers for Incorrect Rim Label

    Keystone RV Company is recalling 2018-2019 Dutchmen Aerolite recreational trailers because the Federal Certification Label lists the wrong rim size, which could lead to unsafe rim replacements.

    Product
    DUTCHMEN — DUTCHMEN AEROLITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2321-2018·2018-07-04

    St Jude Medical Recalls Fortify Assura ICDs for Security Firmware Update

    St Jude Medical is recalling Fortify Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/10004294
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2331-2018·2018-07-04

    BioMerieux Recalls VIDAS FSH Assay Kits Due to Calibration Issues

    BioMerieux SA is recalling VIDAS FSH assay kits due to invalid calibration errors. The recall affects 59 units distributed in the U.S.

    Product
    VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-1596-2018·2018-07-04

    Pacific Brand Charcoal Grilled Eel Recalled for Mebendazole Amine

    Supreme Foods is recalling Pacific Brand Charcoal Grilled Eel because FDA inspections found Mebendazole amine in imported shipments that were distributed.

    Product
    Pacific Brand Charcoal Grilled Eel. Premium Quality Unagi Kabayaki UPC: 692156201099
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2279-2018·2018-07-04

    Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control - Level 2 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.

    Product
    Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2286-2018·2018-07-04

    Horiba Medical Recalls ABX Pentra Micro Albumin Reagents Due to Result Elevation

    Horiba Medical is recalling ABX Pentra Micro Albumin 2 CP reagents because they may produce elevated results if used immediately after a specific creatinine reagent.

    Product
    ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2315-2018·2018-07-04

    Toshiba Diagnostic Ultrasound Systems Recalled for Power Supply Defect

    Toshiba is recalling 162 Aplio I-series diagnostic ultrasound systems because the power supply unit may be damaged and fail to start up.

    Product
    Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
    Category
    Medical Device
    Distribution
    Distributed nationwide