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.

13976–14000 of 21617

  • ModerateFDA (Devices)·Z-2759-2016·2016-09-14

    Teleflex Horizon Manual-Load Ligating Clip Applier Recalled for Incorrect Etching

    Teleflex Medical is recalling 49 units of Horizon Manual-Load Ligating Clip Appliers due to incorrect etching on the device.

    Product
    WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2095-2016·2016-09-14

    Ricker Hill Orchards Apple Cider Recalled for Patulin Levels

    Ricker Hill Orchards is recalling specific apple cider products because they contain patulin at levels higher than the FDA established limit of 50 ppb.

    Product
    Apple Cider: Ricker Hill Orchards Apple Cider 1/2 GAL (64 FL OZ) 1.89 LITERS; NORTHLAND APPLES Pure SWEET MAINE CIDER 1 QUART 947.2ML, UPC: 074613 70009 1 and NORTHLAND APPLES Pure SWEET MAINE CIDER 12 FL. OZ. 355.2 ML, UPC: 0 74613 60009
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1496-2016·2016-09-14

    Teva Recalls Eptifibatide Injection Vials Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 14,661 vials of Eptifibatide Injection due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

    Product
    Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2720-2016·2016-09-14

    ReliaMed Alginate Dressings Recalled for Misplaced Instructions

    Advanced Medical Solutions is recalling ReliaMed Alginate/CMC dressings because instructions for use were misplaced in the packaging.

    Product
    ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1490-2016·2016-09-14

    Amerisource Recalls Mispackaged Adderall XR 30 mg Extended-Release Capsules

    Amerisource Health Services is recalling 761 cartons of Adderall XR 30 mg capsules due to unit dose mispackaging where blister cavities may contain more than one capsule.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 30 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1497-2016·2016-09-14

    Teva Recalls Ondansetron Injection Vials Due to Manufacturing Deviations

    Teva North America is recalling 13,223 vials of Ondansetron Injection USP due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

    Product
    Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2757-2016·2016-09-14

    Sorin Coronary Artery Perfusion Cannula Recalled for Tip Angle Defect

    Sorin Group USA is recalling 1,205 units of Coronary Artery Perfusion Cannulas with Balloons because the tip angle is less than the required 45 or 90 degrees.

    Product
    Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1480-2016·2016-09-14

    Isomeric Pharmacy Recalls Methylprednisolone Acetate/Lidocaine Injection Due to Sterilization Issue

    Isomeric Pharmacy Solution, LLC is recalling Methylprednisolone Acetate/Lidocaine HCl Injection because excessive sterilization time may cause difficulty resuspending particles.

    Product
    Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2739-2016·2016-09-14

    GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Loss Risk

    GE Healthcare is recalling Centricity Enterprise Archive software version 3.0.x due to a potential for data loss when the cache disk is nearly full.

    Product
    Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1488-2016·2016-09-14

    Amerisource Recalls Mispackaged Adderall XR 20 mg Extended-Release Capsules

    Amerisource Health Services is recalling 666 cartons of Adderall XR 20 mg capsules due to unit dose mispackaging where blister cavities may contain more than one capsule.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2078-2016·2016-09-14

    Nature Made Vitamin D Tablets Recalled for Yeast and Mold

    Pharmavite is recalling specific lots of Nature Made Vitamin D tablets because they may exceed specifications for yeast and mold.

    Product
    Nature Made(R) D3 1000IU, 350 count, UPC 0-31604-04070-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2741-2016·2016-09-14

    Arrow Radial Artery Catheterization Kits Recalled for Shipping Labeling Error

    Arrow International Inc. is recalling 690 Radial Artery Catheterization Kits due to a shipping carton labeling error. The kits were distributed to Ohio, Indiana, Tennessee, North Carolina, and Kentucky.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1474-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47477-5, Shade 02 (VF-N)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2706-2016·2016-09-07

    Terumo Cardiovascular Procedure Kits Recalled for Incorrect Tubing Coating Labeling

    Terumo is recalling 2,207 cardiovascular procedure kits because they are labeled as containing coated tubing but actually contain non-coated tubing.

    Product
    Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2005-2016·2016-09-07

    Natrium Products Recalls Sodium Bicarbonate Due to Lubricating Oil Contamination

    Natrium Products Inc. is recalling 1,677 bags of sodium bicarbonate that may contain varying amounts of food-grade lubricating oil.

    Product
    SODIUM BICARBONATE, CAS # 144-55-8, USP/FCC GRADE 1, NET WEIGHT 50 lbs./22.68 kg --- Natrium Products, Inc. 58 Pendleton Street, Cortland, NY 13045
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2685-2016·2016-09-07

    Merge Healthcare Recalls RadSuite Software Due to Image Display Errors

    Merge Healthcare is recalling RadSuite software versions 8.30.6 through 8.30.6.3 because interventional radiology images are not displaying correctly.

    Product
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1475-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47478-2, Shade 03 (MF-N)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2690-2016·2016-09-07

    Fujifilm Digital Mammography System Recalled for Biopsy Workflow Error

    Fujifilm is recalling two Aspire HD Digital Mammography Systems because an aborted stereo biopsy may cause an error that prevents the system from operating properly.

    Product
    FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1477-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48240-4, Shade 05 (D-G)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1478-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48241-1, Shade 06 (D-G)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2711-2016·2016-09-07

    Nidek Specular Microscope CEM-530 Software Recall for Unapproved Feature

    Nidek Inc is recalling 29 Specular Microscope CEM-530 units because software versions 1.08 and 1.09 include an unapproved analysis feature.

    Product
    SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of…
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2686-2016·2016-09-07

    Merge Healthcare Recalls iConnect Enterprise Archive Due to Image Display Issues

    Merge Healthcare is recalling iConnect Enterprise Archive software because interventional radiology images are not displaying correctly in RadSuite.

    Product
    iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.
    Category
    Medical Device
    Distribution
    2 states