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.

13151–13175 of 21617

  • ModerateFDA (Drugs)·D-0476-2017·2017-02-22

    Actavis Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure

    Actavis Inc is recalling specific lots of Glipizide extended-release tablets because they failed to meet dissolution specifications at the 10-hour testing point.

    Product
    Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1204-2017·2017-02-22

    Siemens CentraLink Software Recalled for Potential Sample Type Omission

    Siemens is recalling CentraLink Data Management System software versions v13x, v14x, and v15x because the system may download orders to the ADVIA Automation System without specifying the sample type.

    Product
    CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1189-2017·2017-02-22

    BD Vacutainer Blood Collection Tubes Recalled for Excess Anticoagulant

    Becton Dickinson is recalling specific lots of BD Vacutainer blood collection tubes because they contain approximately twice the expected amount of buffered sodium citrate additive.

    Product
    BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0479-2017·2017-02-22

    Teva Recalls Mimvey Lo Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals USA is recalling specific lots of Mimvey Lo tablets because they failed impurity specifications for norethindrone.

    Product
    Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1200-2017·2017-02-22

    BioMerieux Recalls VIDAS 3 Software Version 1.1.4 Due to Anomalies

    BioMerieux SA is recalling 1,161 units of VIDAS 3 software version 1.1.4 in the U.S. because anomalies identified during the development of version 1.2 were found to be present in the current field version.

    Product
    VIDAS 3 software v. 1.1.4
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1190-2017·2017-02-22

    Greatbatch Recalls T5766 Offset Reamer Handles Due to Drive Chain Seizure

    Greatbatch Medical is recalling 1,441 T5766 Offset Reamer Handles because the drive chain U-joints may seize during hip surgery, rendering the device non-functional.

    Product
    Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed using a reamer cutting instrument. The reamer handles are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1221-2017·2017-02-22

    Atrium Medical Recalls 8 Fr Thoracic Catheters Due to Labeling Error

    Atrium Medical Corporation is recalling 8 Fr Straight Thoracic Catheters because the label depicts six eyelets instead of the correct two.

    Product
    Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1198-2017·2017-02-22

    Arthrex Shoulder Suspension Tower Recalled for Loose Screw Risk

    Allen Medical Systems is recalling 112 Arthrex Shoulder Suspension Towers because fastening screws may come loose and enter the sterile field.

    Product
    Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0478-2017·2017-02-22

    Accord Healthcare Recalls Lisinopril Tablets Due to Missing Break Line

    Accord Healthcare is recalling 12,896 bottles of 5 mg Lisinopril tablets because the tablets are missing a break line. The recall covers the U.S. and Puerto Rico.

    Product
    Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1196-2017·2017-02-22

    Argon Medical Devices Recalls Harvest Needles Due to Sterility Concerns

    Argon Medical Devices is recalling 15 boxes of Harvest Needles because a potential defect in the blister packaging may compromise the sterility of the product.

    Product
    HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1483-2017·2017-02-22

    Crystal Geyser Sparkling Mineral Water Recalled for Missing Plastic Piece

    Crystal Geyser is recalling specific lots of sparkling mineral water because a piece of orange plastic from the filler tube was found missing.

    Product
    Crystal Geyser Sparkling Mineral Water, Original; 18 oz. (53 ml) plastic bottles sold in 28 pack wrapped tray. UPC codes: Bottle Label  6 54871 18001 1 Case  6 54871 18249 7
    Category
    Food
    Distribution
    1 state
  • ModerateNHTSA·17V106000·2017-02-17

    Keystone Recalls 2017 Dutchmen Coleman Trailers for Incorrect Tire Labeling

    Keystone is recalling 2017 Dutchmen Coleman recreational trailers because the Federal Identification Tag lists incorrect tire and rim sizes, which could lead to improper equipment use.

    Product
    DUTCHMEN — DUTCHMEN COLEMAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1143-2017·2017-02-15

    Physio-Control Recalls LIFEPAK 12 Defibrillators with Erratic CO2 Readings

    Physio-Control is recalling LIFEPAK 12 Defibrillators because the End-Tidal CO2 reading may intermittently display an invalid value of XXX during operation.

    Product
    LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1150-2017·2017-02-15

    Stryker Leibinger Recalls Non-Sterile Medpor Implant Sizer Sets Due to Labeling Error

    Stryker Leibinger is recalling specific non-sterile Medpor implant sizer sets because they were incorrectly labeled as sterile. The recall covers 619 units distributed in the US and several international countries.

    Product
    9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0469-2017·2017-02-15

    VistaPharm Recalls Potassium Chloride Oral Solution Due to Cup Leakage

    VistaPharm is recalling 13,609 cases of Potassium Chloride Oral Solution because the unit dose cups may leak at the seal.

    Product
    Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL 33771.
    Category
    Drug
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-1140-2017·2017-02-15

    Siemens Dimension Ammonia Reagent Cartridges Recalled for Calibration Issues

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Ammonia Flex reagent cartridges because they may not meet the 60-day calibration interval claim, potentially leading to abnormal assay results.

    Product
    Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1141-2017·2017-02-15

    Siemens Dimension Vista Ammonia Flex Reagent Cartridge Recall

    Siemens is recalling specific lots of Dimension Vista Ammonia Flex reagent cartridges because they may not meet the 60-day calibration interval claim, potentially resulting in abnormal assay results.

    Product
    Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1151-2017·2017-02-15

    Vertebral Technologies Recalls InterFuse Tail Traction Tool Due to Fit Issues

    Vertebral Technologies is recalling 63 InterFuse Tail Traction Tools because they may not fit properly with the InterFuse T implant.

    Product
    InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse S or InterFuse T implant system. The system has a modular design to allow…
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1181-2017·2017-02-15

    Ortho VITROS FS Calibrator 1 Recalled Due to Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS FS Calibrator 1, Lot 91461, because it cannot calibrate dLDL reagents when used with specific Assay Data Disk versions.

    Product
    VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integrated Systems. --- Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1139-2017·2017-02-15

    Encore Medical Recalls Empowr PS Knee Tibial Inserts Due to Missing Feature

    Encore Medical is recalling 24 Empowr PS Knee Tibial Inserts because they are missing the impaction slot feature.

    Product
    Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1179-2017·2017-02-15

    Ortho-Clinical VITROS UPRO Slides Recalled for Variable Urine Protein Results

    Ortho-Clinical Diagnostics is recalling VITROS UPRO Slides because they may produce variable urine protein results.

    Product
    VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·17V091000·2017-02-10

    Heartland Recalls 2017 Sundance Trailers for Missing Weight Rating Label

    Heartland is recalling 2017 Sundance recreational trailers because the Federal Certification label may be missing the Gross Vehicle Weight Rating, which could lead to overloading.

    Product
    HEARTLAND — HEARTLAND SUNDANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0452-2017·2017-02-08

    Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures

    Dr. Reddy's Laboratories is recalling Flucanazole 200 mg tablets nationwide due to failed dissolution specifications and stability issues.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0451-2017·2017-02-08

    Dr. Reddy's Recalls Flucanazole Tablets Due to Dissolution Failures

    Dr. Reddy's Laboratories is recalling Flucanazole 150 mg tablets because they failed dissolution specifications and 18-month stability testing.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1109-2017·2017-02-08

    Immuno-Mycologics Recalls Cryptococcal Antigen Lateral Flow Assay Due to False Positives

    Immuno-Mycologics is recalling 630 units of the Cryptococcal Antigen Lateral Flow Assay because specific lots have lower specificity, leading to reported false positive results.

    Product
    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
    Category
    Medical Device
    Distribution
    Distributed nationwide