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.

19751–19775 of 21751

  • ModerateFDA (Devices)·Z-0310-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling Slide Dispense cartridges used with VITROS Chemistry Product Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VITROS DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0327-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides due to slide dispense issues. The recall affects 31,395 units distributed worldwide.

    Product
    VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protein (UPRO) concentration in urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0303-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS CHE Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS CHE Slides because of slide dispense issues. The recall affects 11,135 units distributed worldwide.

    Product
    VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 8004707 VITROS CHE Slides quantitatively measure cholinesterase (CHE) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0307-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS CRBM Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS CRBM Slides because of slide dispense issues. The slides are used to measure carbamazepine levels in serum and plasma.

    Product
    VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0316-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Li Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Li Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 1632660 VITROS Li Slides quantitatively measure lithium (Li) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0306-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues.

    Product
    VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8001133 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0312-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 VITROS ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0315-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS LAC Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS LAC Slides because slide dispense cartridges may cause dispensing issues.

    Product
    VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0294-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry ALB Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry ALB Slides due to slide dispense issues. The recall affects 16,583 units distributed worldwide.

    Product
    VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0322-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Slide Dispense cartridges due to slide dispense issues. The recall affects 19,438 units distributed worldwide.

    Product
    VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protein (PROT) concentration in cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0365-2014·2013-11-27

    Siemens Chemistry Calibrator Recall for Direct Bilirubin Assay Shift

    Siemens is recalling Chemistry Calibrators for the Direct Bilirubin Assay because reassigned System Specific Values may cause an average shift in results.

    Product
    Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage: DBIL_2: For in vitro diagnostic use in the quantitative determination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0366-2014·2013-11-27

    Teleflex Medical Recalls Green Rusch Laryngoscope Blades for Labeling Inconsistency

    Teleflex Medical is recalling 6,200 Green Rusch laryngoscope blades due to a labeling inconsistency. The devices were distributed nationwide.

    Product
    Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0298-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slide Dispense cartridges due to slide dispense issues.

    Product
    VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0354-2014·2013-11-27

    Restoration Robotics Recalls ARTAS Disposable Kits Due to Pin Discoloration

    Restoration Robotics is recalling ARTAS Disposable Kits because skin tensioner pins have discoloration from insufficient cleaning during manufacturing.

    Product
    ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline Nose Cone FP-45387; Follicle Trap - FP-23306 and Non-sterile Disposable Clinical Kit FP -23267): and ARTAS Disposable Kits, 18 Gauge…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-010-2014·2013-11-27

    Greenstone Recalls Spironolactone Tablets Due to Unapproved Manufacturing Site Change

    Greenstone LLC is recalling 2,796 bottles of Spironolactone 25 mg tablets because they were manufactured at an unapproved site, altering the dissolution profile.

    Product
    Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0185-2014·2013-11-27

    Nature Made Multivitamin Softgels Recalled Due to Reduced Vitamin Potency

    Pharmavite is voluntarily recalling Nature Made multivitamin softgels because quality tests show Vitamins B1 and B12 are losing potency faster than expected.

    Product
    Multi for Her (Full Strength Mini and Multi Softgels), 60 Count Bottle. 24 units per master case. Product labeling reads in part:"NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0358-2014·2013-11-27

    Wexford Labs Recalls Expired Thymo-Cide Germicidal Detergent

    Wexford Labs is recalling Thymo-Cide germicidal detergent because expired active ingredient was used in its manufacture.

    Product
    Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0338-2014·2013-11-27

    Synovis Recalls Vascu Guard and Dura-Guard Patches Due to Shipping Configuration Issues

    Synovis is recalling Vascu Guard and Dura-Guard patches because specific fluid ounce units shipped in divided cell configurations with a specific revision of the Instructions for Use.

    Product
    Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular reconstruction. Product Code: VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0296-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS ALKP Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS ALKP Slides because of slide dispense issues. The recall affects 183,267 units distributed worldwide.

    Product
    VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0355-2014·2013-11-27

    Restoration Robotics Recalls Sterile Disposable Kits Due to Pin Discoloration

    Restoration Robotics is recalling sterile disposable kits used in hair restoration because skin tensioner pins have discoloration from insufficient cleaning.

    Product
    Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0331-2014·2013-11-27

    ConMed Altrus Thermal Tissue Fusion Handpieces Recalled for Particulate Matter

    ConMed is recalling 65 Altrus Thermal Tissue Fusion handpieces exposed to excessive particulate matter during manufacture, which could cause minor local infections.

    Product
    ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus¿ Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0201-2014·2013-11-27

    American Beverage Corp Recalls Big Juicy Fruit Punch Drink Bottles

    American Beverage Corp is recalling Big Juicy Fruit Punch Drink in 10 oz plastic bottles due to a potential choking hazard from the sports cap.

    Product
    Big Juicy Fruit Punch Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0187-2014·2013-11-27

    Nature Made Multi Vitamins Recalled Due to Reduced Potency

    Pharmavite is recalling Nature Made Multi vitamins because quality tests show Vitamins B1 and B12 are losing potency faster than expected.

    Product
    Multi For Him (Full Strength Mini and Multi Softgels), 60 Count Bottle. 24 units per master case. Product labeling reads in part:"NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A…
    Category
    Drug
    Distribution
    Distributed nationwide