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.

19776–19800 of 21751

  • ModerateFDA (Devices)·Z-0369-2014·2013-11-27

    Synthes Titanium Trochanteric Fixation Nail Recall for Non-Conforming Blades

    Synthes USA is recalling Titanium Trochanteric Fixation Nail (TFN) Helical Blades due to a potential for non-conforming products to be distributed.

    Product
    Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0295-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product ALC Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product ALC Slides due to slide dispense issues affecting the cartridges used with the product.

    Product
    VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Slides quantitatively measure ethanol (ALC) 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-0321-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges

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

    Product
    VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) 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-0319-2014·2013-11-27

    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 6,606 units distributed worldwide.

    Product
    VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma 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-0313-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Fe Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Fe Slides due to slide dispense issues. The recall affects 37,525 units distributed worldwide.

    Product
    VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924547 VITROS Fe Slides quantitatively measure iron (Fe) 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-0318-2014·2013-11-27

    Ortho-Clinical 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 Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0372-2014·2013-11-27

    Hospira Recalls Symbiq Infuser Batteries Due to Incorrect Model Shipment

    Hospira is recalling 59 Symbiq infuser batteries because the wrong model (E10) was shipped instead of the correct E09 model.

    Product
    *** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; *** E10 batteries can be…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0360-2014·2013-11-27

    Salter Labs Recalls CO2 Sample Lines Due to Incorrect Length

    Salter Labs is recalling specific lots of 15-foot CO2 sample lines because they may contain 30-foot tubes instead.

    Product
    Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0325-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges

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

    Product
    VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 1307164 VITROS THEO Slides quantitatively measure theophylline (THEO) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0219-2014·2013-11-27

    Best in Nature Eye Care Essence Recalled for Missing Ingredients

    Diamond Nutriceutical, Inc. is recalling Best in Nature Eye Care Essence because FDA testing found the product lacked labeled amounts of Vitamin A and Vitamin C.

    Product
    Best in Nature Brand Eye Care Essence, 100 Capsules. Product labeling reads in part:"Best in Nature Eye Care Essence***Dietary Supplement 100 capsules***Manufactured for: Best in Nature Walnut, CA 91789***www.1688best.com***8 92418 001069 6***".
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0323-2014·2013-11-27

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

    Ortho-Clinical Diagnostics is recalling VITROS SALI Slides because the associated Slide Dispense cartridges have slide dispense issues.

    Product
    VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicylate (SALI) concentration in serum and plasma 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-0263-2014·2013-11-27

    Medtronic Thunder Extra Support Guidewire Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling 58 Thunder Extra Support Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0292-2014·2013-11-27

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

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products ACET Slides because of slide dispense issues. The recall affects 16,732 units distributed worldwide.

    Product
    VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) 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 (Food)·F-0213-2014·2013-11-27

    American Beverage Corp. Recalls Big Burst Kiwi Strawberry Drink Bottles

    American Beverage Corp. is recalling Big Burst Kiwi Strawberry Drink bottles due to a potential choking hazard from dislodged cap parts.

    Product
    Big Burst Kiwi Strawberry Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-005-2014·2013-11-27

    L. Perrigo Recalls Infants' Pain and Fever Due to Unmarked Syringes

    L. Perrigo Co. is recalling 27,504 bottles of TopCare Infants' Pain and Fever because some cartons may contain dosing syringes without dose markings.

    Product
    TOPCARE INFANTS PAIN AND FEVER — TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0308-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry CREA Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry CREA Slides due to slide dispense issues. The recall affects 364,752 units distributed worldwide.

    Product
    VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine 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-0297-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS AMON Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS AMON Slides due to slide dispense issues. The recall affects 24,322 units distributed worldwide.

    Product
    VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926 VITROS AMON Slides quantitatively measure ammonia concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0347-2014·2013-11-27

    Riverpoint Recalls Vilet Surgical Suture Due to Labeling Error

    Riverpoint Medical is recalling 1,932 pieces of Vilet surgical suture because the label incorrectly states the suture is undyed when it is actually violet.

    Product
    Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0302-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Ca Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Ca Slides because of slide dispense issues with the cartridges used to dispense them.

    Product
    VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0184-2014·2013-11-27

    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 Complete (Full Strength Mini and Multi Softgels), 60 Count Bottle. 24 units per master case.+++Multi Complete (club size) (Full Strength Mini and Multi Softgels), 180 Count Bottle. 20 units per master case. Product labeling reads in part:"NatureMade***DIETARY…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0353-2014·2013-11-27

    Restoration Robotics Recalls Epsilon Skin Tensioner Due to Pin Discoloration

    Restoration Robotics is recalling Epsilon Skin Tensioner devices because stainless steel pins may have discoloration from insufficient cleaning during passivation.

    Product
    Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0336-2014·2013-11-27

    Terumo Recalls Mislabelled Vascutek Gelsoft Vascular Grafts

    Terumo CVS is recalling nine Vascutek Gelsoft vascular grafts because they were incorrectly labeled with the wrong diameter.

    Product
    Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0357-2014·2013-11-27

    Zimmer Trinica Anterior Lumbar Plate Instrument Tray Recall for Sterilization Issues

    Zimmer Spine is recalling Trinica ALP Instrument Trays because ratchet handles may not sterilize effectively due to tray design interference.

    Product
    Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0176-2014·2013-11-27

    Bio-Cat Recalls Cellulase Enzyme Blends Due to Chloramphenicol Contamination

    Bio-Cat Inc is recalling Cellulase Enzyme Blends intended for food manufacturing due to potential chloramphenicol contamination.

    Product
    Cellulase Enzyme Blends, bulk, custom blended formulations identified as Cellulase BX and Celluase Conc, packed in boxes or drums ranging from 1 kg to 25 kg, item # CELIND, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800)…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0186-2014·2013-11-27

    Pharmavite Recalls Nature Made Multivitamin Softgels Due to Potency Loss

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

    Product
    Multi for Her 50+ (Full Strength Mini and Multi softgels) 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 1-800-276-2878…
    Category
    Drug
    Distribution
    Distributed nationwide