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.

15826–15850 of 21645

  • ModerateFDA (Food)·F-3075-2015·2015-09-09

    think Thin Oatmeal Recalled for Incorrect Honey Peanut Butter Labeling

    Interpac Technologies is recalling think Thin oatmeal cups that have the correct lid but an incorrect Honey Peanut Butter label. The product contains visible nuts.

    Product
    think Thin Protein & Fiber Oatmeal, Madagascar Vanilla, Almonds, Pecans; 10 g Protein, 5 g Fiber, 190 calories; Net wt 1.76 oz. (50g); (Nuts are visible in product when lid is opened. Tray - 12 x 1.76 oz cups UPC 753656711881: Individual cup UPC 753656 711874 Ingredients…
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2723-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 8 mm Flow Probes due to a software defect that causes flow meters to display incorrect error messages.

    Product
    Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3069-2015·2015-09-09

    HoneyCombs Formula IM Recalled for Excessive Coliform Bacteria

    HoneyCombs Industries is recalling 55 bottles of Formula IM because the powdered golden seal ingredient contained coliform bacteria levels above the specified limit.

    Product
    Formula IM packaged in 1 FL OZ (29mL) droppers. HoneyCombs Industries, 10671 6075 Road, Montrose, CO 81403.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2015·2015-09-02

    BD CD56 PE Cy 7 Reagent Recalled for Unexpected Staining Patterns

    Becton, Dickinson and Company is recalling three lots of CD56 PE Cy 7 reagent because they contain a low amount of HLA-DR PE antibody, which could result in an unexpected staining pattern.

    Product
    BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2472-2015·2015-09-02

    Baxter MiniCap Peritoneal Dialysis Transfer Set Labeling Recall

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets to update labeling with safety instructions and warnings.

    Product
    MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3054-2015·2015-09-02

    Nepali Finger Chips Recalled for Undeclared Tartrazine

    Balajee Trade Link LLC is recalling Rato Bhale Nepali Finger Chips because the product contains undeclared tartrazine (yellow #5).

    Product
    Rato Bhale Nepali Finger Chips Product of Nepal Weight: 200g (7.05 OZ) Imported by: Balajee Trade Link, LLC, PA USA Batch No. 01-15
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2442-2015·2015-09-02

    Medtronic Guardian Real-Time Monitor Recalled for Finnish Translation Error

    Medtronic MiniMed is recalling 254 Guardian Real-Time Monitors distributed in Finland due to a language translation error that reverses the on-screen labels for LOW and HIGH glucose alerts.

    Product
    Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1377-2015·2015-09-02

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's Laboratories is recalling Amlodipine Besylate and Atorvastatin Calcium tablets because the atorvastatin component is subpotent.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2477-2015·2015-09-02

    Nidek OPD-Scan III Recall for Software Aberration Calculation Error

    Nidek Inc is recalling 3,836 OPD-Scan III Refractive Power/Corneal Analyzers due to a software bug that incorrectly calculates high-order aberrations.

    Product
    OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2441-2015·2015-09-02

    Iris Diagnostics Recalls iChemVELOCITY Urine Chemistry Systems for Labeling Error

    Iris Diagnostics is recalling iChemVELOCITY Automated Urine Chemistry systems because they do not maintain the claimed 5-day strip stability under specified conditions.

    Product
    iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2463-2015·2015-09-02

    Hardy Diagnostics Recalls HardyCHROM MRSA In Vitro Diagnostic Plates

    Hardy Diagnostics is recalling HardyCHROM MRSA plates due to a potential quality control issue involving the MSSA strain.

    Product
    HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2460-2015·2015-09-02

    ASO Recalls Carepak Bandages Due to Unlabeled Benzalkonium Chloride

    ASO, LLC is recalling Carepak Sheer Adhesive Bandages because 5/8 bandages contain 0.1% Benzalkonium Chloride, which is not listed on the label.

    Product
    Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2475-2015·2015-09-02

    Synthes Sternal ZIPFIX Application Instrument Recalled Due to Detaching End Cap

    Synthes (USA) Products LLC is recalling 451 Sternal ZIPFIX Application Instruments because the end cap may loosen and detach, rendering the instrument non-functional.

    Product
    Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2374-2015·2015-09-02

    Ethicon Recalls SEDASYS Sedation Systems Due to Plastic Degradation

    Ethicon is recalling 14 SEDASYS Computer-Assisted Personalized Sedation Systems because unspecified disinfecting methods caused the plastic material of the Control Unit to degrade.

    Product
    SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2469-2015·2015-09-02

    GE Healthcare Recalls Centricity PACS-IW Systems Due to Missing Images

    GE Healthcare is recalling 82 Centricity PACS-IW systems because medical images may be missing when a specific system parameter is set to a value greater than 1.

    Product
    Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2459-2015·2015-09-02

    Advanced Sterilization Products Recalls CIDEX Activated Dialdehyde Solution

    Advanced Sterilization Products is recalling CIDEX Activated Dialdehyde Solution because it may lack adequate data to support its 24-month shelf life.

    Product
    CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2474-2015·2015-09-02

    Baxter Recalls CAPD Solution Transfer Sets for Labeling Revisions

    Baxter Healthcare Corp. is recalling 35,460 units of CAPD Solution Transfer Sets to update labeling with additional safety instructions and warnings.

    Product
    CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2449-2015·2015-09-02

    Carestream DRX-Evolution X-Ray System Recalled for Image Stitching Defect

    Carestream Health is recalling DRX-Evolution X-ray systems due to a software defect that may cause undetected image stitching inconsistencies.

    Product
    CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2464-2015·2015-09-02

    Trilliant Surgical Recalls Tiger Cannulated Screw System Tray Lids

    Trilliant Surgical Ltd. is recalling 71 units of Tiger Cannulated Tray Lids because they are occasionally difficult to remove from sterilization trays.

    Product
    Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2452-2015·2015-09-02

    Trilliant Surgical Recalls 3.0/4.0 Cannulated Drill Bits Due to Sizing Issue

    Trilliant Surgical Ltd. is recalling 121 units of 3.0/4.0 Cannulated Drill Bits because the inner diameter is too small for the guide wire to pass through.

    Product
    3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2465-2015·2015-09-02

    Tornier Recalls Salto Talaris Tibial Guide Due to Assembly Defect

    Tornier is voluntarily recalling five units of the Salto Talaris Tibial Guide because they cannot be assembled to the Talar Pin Setting guide.

    Product
    Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2473-2015·2015-09-02

    Baxter MiniCap Extended Life PD Transfer Set Labeling Recall

    Baxter Healthcare Corp. is recalling 33,474 units of MiniCap Extended Life PD Transfer Sets to update labeling with additional safety instructions and warnings.

    Product
    MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1373-2015·2015-09-02

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's Laboratories is recalling 1,056 bottles of Amlodipine Besylate and Atorvastatin Calcium tablets because the atorvastatin component is subpotent.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2468-2015·2015-09-02

    Stryker recalls mislabeled 5mm trocar sleeves due to length discrepancy

    Stryker Sustainability Solutions is recalling 90 reprocessed trocar sleeves labeled as 100mm but containing 75mm models.

    Product
    Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2448-2015·2015-09-02

    Alcon Recalls LX3 Microscope Floor Stands Due to Cabling Issues

    Alcon is voluntarily recalling LX3 Microscope Floor Stands because cabling issues may cause loss of functionality or illumination failure.

    Product
    LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable…
    Category
    Medical Device
    Distribution
    Distributed nationwide