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.

18951–18975 of 21751

  • ModerateFDA (Devices)·Z-0901-2014·2014-02-05

    Merit Medical Systems Recalls RAD BOARD Devices Due to Missing Labels

    Merit Medical Systems is voluntarily recalling one lot of RAD BOARD devices because missing labels may allow incorrect orientation, potentially obscuring patient anatomy during fluoroscopy.

    Product
    Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure. The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-1042-2014·2014-02-05

    Wockhardt Recalls Pantaprazole Sodium Tablets Due to Dissolution Failure

    Wockhardt USA is recalling 1,129 bottles of Pantaprazole Sodium 40 mg tablets because they failed dissolution specifications.

    Product
    Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0829-2014·2014-02-05

    Anspach Recalls Single-Use Sterile Bone Cutting Burs Due to Length Discrepancy

    The Anspach Effort, Inc. is recalling 599 single-use sterile bone cutting burs because the cutters were longer than stated on the label.

    Product
    AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0868-2014·2014-02-05

    Siemens Free T3 Assay Kits Recalled for Positive Bias in Results

    Siemens Healthcare Diagnostics is recalling Free T3 Assay kits due to a positive bias that may cause normal thyroid patients to appear abnormal.

    Product
    T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMULITE 2000/IMMULITE 200 XPi Analyzers --- Origin: UK Siemens Healthcare…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1053-2014·2014-02-05

    Watson Recalls Hydrocodone and Acetaminophen Tablets Due to Broken Tablets

    Watson Laboratories is recalling 717 bottles of Hydrocodone Bitartrate and Acetaminophen tablets because the product contains broken tablets.

    Product
    Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01.
    Category
    Drug
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0892-2014·2014-02-05

    Synergetics Vivid Endo Illuminator Recalled for Faulty Sterile Seals

    Synergetics Inc. is recalling Vivid Endo Illuminators because faulty seals on the outer pouch could fail, compromising the sterile status of the single-use ophthalmic devices.

    Product
    Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0900-2014·2014-02-05

    Boston Scientific Recalls 1068 Peripheral Imaging Catheters Due to Guidewire Issues

    Boston Scientific is recalling 1,068 units of the Atlantis PV 8.5F Peripheral Imaging Catheter because physicians reported an inability to pass a guidewire through the device.

    Product
    Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0825-2014·2014-02-05

    Siemens ACUSON SC2000 Ultrasound System Recalled for Control Panel Lock Failure

    Siemens is recalling 271 ACUSON SC2000 ultrasound systems because the control panel locking mechanism can fail, making the device difficult to steer during transport.

    Product
    ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1442-2014·2014-02-05

    LSG Food World Recalls Fu Zhou Vermicelli for Filth and Misbranding

    LSG Food World Inc. is recalling Fu Zhou Vermicelli due to filth and missing English translations. The product was distributed in New York.

    Product
    Lam Sheng Kee Fu Zhou Vermicell, Net Wt. 4.4 LB (2000 g), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6949682 803360; Manufactured by LAM SHENG KEE (HK) INTERNATIONAL LIMITED RM3. 8/F, YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI HK; Distributed…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0867-2014·2014-02-05

    Siemens Free T3 Assay Kits Recalled for Positive Bias in Results

    Siemens Healthcare Diagnostics is recalling Free T3 Assay kits due to a positive bias that may cause normal thyroid patients to appear abnormal.

    Product
    T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit package: 100, 200, 500 and 600 test kits --- Origin: UK Siemens Healthcare Diagnostics Products…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1447-2014·2014-02-05

    Mexpogroup Cactus Recalled for Unapproved Pesticide Residues in California

    Shasta Produce is recalling Mexpogroup Cactus in California due to the presence of pesticides without established US tolerance levels.

    Product
    Mexpogroup Cactus Grown in Mexico; 44 lbs, 20 KG; Calle El Rosario #20581 Col Buenos Aires Norte C.P. 22700 Tijuana, Mexico.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0840-2014·2014-02-05

    GE Optima CT Systems Recalled for Manual Film Composer Data Mismatch

    GE Healthcare is recalling 272 Optima CT520 and CT540 systems because the Manual Film Composer feature may display or print images with incorrect patient names or mismatched image previews.

    Product
    GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0848-2014·2014-02-05

    Maquet Compressor Mini Recalled for Excessive Compressed Air Temperature

    Maquet is recalling 237 Compressor Mini units because they may deliver compressed air at a temperature higher than specified.

    Product
    Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0832-2014·2014-02-05

    Philips Brilliance iCT Computed Tomography Systems Recalled for Image Artifacts

    Philips is recalling seven Brilliance iCT and iCT SP CT scanners because patient images exhibited ring artifacts.

    Product
    Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0841-2014·2014-02-05

    BioMérieux Recalls ZYM B Reagent Due to Visual Defect and False Negatives

    BioMérieux is recalling ZYM B Reagent (REF 70493) because a visual defect and activity issue can cause false negative results in API biochemical tests.

    Product
    ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1446-2014·2014-02-05

    Hnos. Perez Cactus Pads Recalled for Unpermitted Pesticides

    West Coast Produce is recalling Hnos. Perez brand cactus pads found to contain unpermitted pesticides in California.

    Product
    Hnos. Perez brand cactus leaves (pads): distributed by: West Coast Produce 300 Franklin St. Oakland, CA 94607
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0847-2014·2014-02-05

    Zimmer Dental Recalls Tapered Screw-Vent Implant Lot Due to Labeling Error

    Zimmer Dental is voluntarily recalling a specific lot of Tapered Screw-Vent Implants because some packages may display incorrect size information on the cap label.

    Product
    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0843-2014·2014-02-05

    BioMérieux Recalls API NH Kits Due to ZYM B Reagent Defect

    BioMérieux is recalling API NH kits because a defect in the ZYM B reagent may cause false negative results in biochemical tests.

    Product
    API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1448-2014·2014-02-05

    Marquez Produce Recalls Fresh Cactus Due to Unapproved Pesticides

    Marquez Produce is recalling Fresh Cactus ("Nopal") because it contains unapproved pesticides. The recall affects 352 units distributed in California.

    Product
    Fresh Cactus ("Nopal"), 40lbs/bx
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0850-2014·2014-02-05

    Kimberly-Clark Radiofrequency Cannula Recalled for Incorrect Active Tip Length

    Kimberly-Clark is recalling Radiofrequency Cannulas where the active tip may be 5mm instead of the labeled 10mm, potentially affecting lesion creation in nervous tissue.

    Product
    Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator…
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0830-2014·2014-02-05

    Anspach Twist Drill Recall Due to Incorrect Length Labeling

    The Anspach Effort, Inc. is recalling 29 single-use sterile twist drills because the cutters were longer than stated on the label.

    Product
    Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-1451-2014·2014-02-05

    Mars Recalls Uncle Ben's Mexican Flavor Rice Due to Flushing Reports

    Mars Food US is recalling Uncle Ben's Infused Rice Mexican Flavor due to reports of flushing reactions after consumption.

    Product
    Uncle Ben's (R), Infused(R) Rice Mexican Flavor rice, NET WT 5 LB (2.27 kg), distributed by MARS Foodservices US, P.O. Box 5059, Rancho Dominguez, CA 90224-5059
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0853-2014·2014-02-05

    GE Healthcare Recalls Innova IGS 630 Biplane Imaging Systems

    GE Healthcare is recalling 28 Innova IGS 630 biplane imaging systems because a specific user action may cause the X-ray function to lock up.

    Product
    GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1450-2014·2014-02-05

    Washington Vegetable Co Recalls Cactus Pads Due to Unapproved Pesticides

    Washington Vegetable Co is recalling Cactus Pads (Nopal) from Mexico because unapproved pesticides were found during sampling by the CA Department of Pesticide Regulation.

    Product
    Cactus Pads (Nopal) Mexpogroup: Product of Mexico
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-922-2014·2014-01-29

    FDA Recalls Levothyroxine Sodium Tablets Due to Potential Labeling Error

    Aidapak Services is recalling Levothyroxine Sodium 112 mcg tablets because they may have been mislabeled as Raltegravir 400 mg.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527134601.
    Category
    Drug
    Distribution
    4 states