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.

20276–20300 of 21633

  • ModerateFDA (Devices)·Z-1564-2013·2013-07-03

    Medtronic Launcher Guiding Catheter Recalled for Labeling Errors

    Medtronic is recalling 24 units of Launcher Guiding Catheters because the packaging labels do not accurately reflect the catheters inside.

    Product
    Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1613-2013·2013-07-03

    Beckman Coulter Recalls Lactate Reagent Due to Calibration Failures

    Beckman Coulter is recalling 3,353 units of SYNCHRON Lactate Reagent because improper storage caused calibration failures, potentially delaying test results.

    Product
    SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator, is intended for the quantitative determination of lactate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-620-2013·2013-07-03

    Kareway Recalls Pure-Aid Allergy Relief Caplets Due to Labeling Error

    Kareway Products Inc. is recalling Pure-Aid Allergy Relief caplets because the foil label incorrectly lists Chlorpheniramine instead of Diphenhydramine.

    Product
    Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-621-2013·2013-07-03

    FDA Recalls Ink-Eeze Tattoo Numbing Spray for Lack of Approval

    Indelicare LLC is recalling Ink-Eeze Tattoo Numbing Spray because it is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1611-2013·2013-07-03

    Terumo Pinnacle Destination Peripheral Guiding Sheath Recalled for Labeling Error

    Terumo Medical Corporation is recalling 20 units of Pinnacle Destination Peripheral Guiding Sheaths because they were incorrectly labeled with extended expiration dates.

    Product
    Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1563-2013·2013-07-03

    Thermo Scientific MAS Bilirubin Recalled for Reduced Stability

    Microgenics Corporation is recalling Thermo Scientific MAS Bilirubin test samples because in-house testing confirmed reduced stability of Direct and Total Bilirubin.

    Product
    Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1612-2013·2013-07-03

    Terumo Glidesheath Recalled for Incorrect Expiration Date Labeling

    Terumo Medical Corporation is recalling 550 units of Glidesheath products due to incorrect expiration date labeling.

    Product
    Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1519-2013·2013-07-03

    GE Healthcare Recalls Senographe Essential Mammography Systems Due to Manual Defect

    GE Healthcare is recalling 49 Senographe Essential mammography systems because a defective CD makes the operator manual inaccessible.

    Product
    GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1534-2013·2013-06-26

    Minute Maid Orange Juice Recalled for Potential Bottle Lip Damage

    Coca-Cola is recalling specific lots of Minute Maid Orange Juice in 10oz and 15.2oz bottles due to potential spoilage or damage to the bottle lip.

    Product
    MINUTE MAID ORANGE JUICE, 10oz and 15.2 oz plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1555-2013·2013-06-26

    Prism Medical Recalls BC Hammock Mesh Sling for Incorrect Size

    Prism Medical Services USA is recalling BC Hammock Mesh Sling (Junior) units because they were produced in the incorrect size.

    Product
    BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-603-2013·2013-06-26

    Hi-Tech Pharmacal Recalls Subpotent HydrOXYzine Hydrochloride Oral Solution

    Hi-Tech Pharmacal is recalling specific lots of HydrOXYzine Hydrochloride Oral Solution because the product failed stability testing and may be subpotent.

    Product
    HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1553-2013·2013-06-26

    Prism Medical Recalls BC Hammock Mesh Slings Due to Incorrect Size

    Prism Medical Services USA is recalling 5 BC Hammock Mesh Slings (Large) because they were produced in the incorrect size.

    Product
    BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1536-2013·2013-06-26

    Minute Maid Cranberry Apple Raspberry Juice Recall for Bottle Lip Damage

    Coca-Cola is recalling specific Minute Maid Cranberry Apple Raspberry juice bottles due to potential spoilage or damage to the bottle lip.

    Product
    MINUTE MAID CRANBERRY APPLE RASPBERRY Flavored Juice Beverage, 15.2 oz, plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1543-2013·2013-06-26

    Bao Gong Da Recalls American Ginseng Due to Pesticide Residues

    Bao Gong Da Inc is recalling American Ginseng products because FDA lab analysis found pesticide residues. The recall covers retail and bulk packages distributed in four states.

    Product
    Ginseng. American Ginseng, 4 oz. and 8 oz. retail packages and bulk ginseng in 20, 30, or 40 lbs. in a clear plastic bag. Bulk products are not labeled.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1545-2013·2013-06-26

    SybronEndo Recalls Dental Power Cords Due to Missing Safety Label

    SybronEndo is recalling 3,615 Elements Obturation Unit power cords because a required Canadian safety label was accidentally omitted from the packaging.

    Product
    SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy, Made in Taiwan The intended use of the Elements Obturation Unit and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1556-2013·2013-06-26

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products-HCY Reagent Lot 1529-17-2636

    Ortho-Clinical Diagnostics is recalling a specific lot of VITROS Chemistry Products-HCY Reagent because it produced lower than expected results.

    Product
    VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1538-2013·2013-06-26

    Minute Maid Mixed Berry Juice Recalled for Potential Bottle Lip Damage

    Coca-Cola is recalling specific lots of Minute Maid Mixed Berry Juice because some bottles may have damaged lips or spoilage.

    Product
    MINUTE MAID Mixed Berry Juice, Flavored Blend of Apple, Grape & Berry Juices, 6/10 oz plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1549-2013·2013-06-26

    Aperio ScanScope Systems Recalled for Incorrect User Guide Labeling

    Aperio Technologies is recalling 364 ScanScope systems because user guides incorrectly claim FDA clearance for diagnostic use, when the devices are for research only.

    Product
    Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1559-2013·2013-06-26

    Hitachi Recalls Echelon and Oasis MR Imaging Systems Due to Software Error

    Hitachi is recalling 45 Echelon, Echelon Oval, and Oasis MR imaging systems due to a software error that can cause image data loss during simultaneous scanning and processing.

    Product
    Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1562-2013·2013-06-26

    Siemens ARTISTE Linear Accelerator Recall for Image Quality Degradation

    Siemens is recalling 8 ARTISTE linear accelerators due to potential image quality degradation that may affect patient position verification during cancer treatment.

    Product
    ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1544-2013·2013-06-26

    SybronEndo Elements Obturation Unit Recalled for Missing Safety Label

    SybronEndo is recalling 3,615 Elements Obturation Units because a required Canadian safety caution label was accidentally omitted from the device and its power cord.

    Product
    SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1557-2013·2013-06-26

    Synthes 11-Hole Tubular Plate Recalled Due to Error in Release

    Synthes USA HQ, Inc. is recalling 10 units of 11-Hole, 1/3 Tubular Plate DCL Plates with Collar because they were released to the US market in error.

    Product
    Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1535-2013·2013-06-26

    Minute Maid Apple Juice Recalled for Potential Bottle Lip Damage

    Coca-Cola is recalling specific lots of Minute Maid Apple Juice because some bottles may have damaged lips or spoilage.

    Product
    MINUTE MAID APPLE JUICE, 100% Juice, 6/10 oz and 15.2 oz, plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1539-2013·2013-06-26

    Jus Made Recalls Roo's Juice Tropical Orange Beverage for Contamination

    Jus Made, Inc. is recalling 1,995 cases of Roo's Juice Tropical Orange Flavor due to potential contamination with bacterial biofilm, mold, and red water mites.

    Product
    Roo's Juice Tropical Orange Flavor (5% juice beverage) 10 FL OZ. (296 mL) Distributed by The Pantry, Inc. Sanford, NC 27330
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-1537-2013·2013-06-26

    Minute Maid Strawberry Passion Juice Recall for Potential Bottle Lip Damage

    Coca-Cola is recalling Minute Maid Strawberry Passion juice bottles due to potential spoilage or damage to the bottle lip.

    Product
    MINUTE MAID STRAWBERRY PASSION Flavored Juice Beverage, 15.2 oz plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA.
    Category
    Food
    Distribution
    Distributed nationwide