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.

15776–15800 of 21645

  • ModerateFDA (Devices)·Z-2749-2015·2015-09-16

    Elcam Medical MANI 3G Plate BLS RAD B.BRAUN Recalled for Punctured Packaging

    Elcam Medical is recalling MANI 3G Plate BLS RAD B.BRAUN manifolds because punctured blister packages were detected during manufacturing, creating a potential for device contamination.

    Product
    Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-3089-2015·2015-09-16

    Coloma Frozen Foods Recalls Red Tart Cherries for Elevated Microbial Counts

    Coloma Frozen Foods is recalling IQF Red Tart Cherries due to potential adulteration from elevated mold, yeast, and coliform counts.

    Product
    IQF Red Tart Cherries, 30 lbs., 2/5 lb packages/case, 4/5 lb. packages per case; packed in cartons, square plastic pails, and poly bag in cartons; Nature Blessed Red Tart Cherries, 4/40 oz. packages per case.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-1420-2015·2015-09-16

    Mutual Pharmaceutical Recalls Felodipine Tablets Due to Chemical Contamination

    Mutual Pharmaceutical is recalling specific lots of Felodipine Extended-Release Tablets because benzophenone leached from the label varnish.

    Product
    Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1427-2015·2015-09-16

    Healthpoint Recalls Surgicept Surgical Hand Scrub Due to Chemical Contamination

    Healthpoint, Ltd is recalling 11,910 bottles of Surgicept surgical hand scrub because a naphthalene compound was identified in the product.

    Product
    Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash in 1150 mL bottles. MARKETED BY: CafeFusion, Leawood, KS 66211, MANUFACTURED FOR: HEALTHPOINT, LTD Ft. Worth, Texas 76107, MANUFACTURED BY: DPT LABORATORIES, LTD 3300 Research Plaza…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2737-2015·2015-09-16

    Mindray DPM 7 Patient Monitors Recalled for Black Screen Display

    Mindray is recalling 13 DPM 7 patient monitors because they may display a black screen, potentially preventing the display of patient data.

    Product
    Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2740-2015·2015-09-16

    DermaPen Pro Micro Needling System Recalled for Lack of FDA Clearance

    Derma Pen, LLC is recalling DermaPen Pro Micro Needling Systems because the devices were distributed without FDA clearance or approval.

    Product
    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2744-2015·2015-09-16

    Biomet C-Tek Maxan Anterior Cervical Plate System Mislabeled Recall

    Biomet Spine is recalling 7 parts of the C-Tek Maxan Anterior Cervical Plate System because some units were mislabeled with an incorrect part number.

    Product
    Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1425-2015·2015-09-16

    Mutual Pharmaceutical Recalls Imipramine HCl Tablets Due to Chemical Contamination

    Mutual Pharmaceutical is recalling Imipramine HCl tablets because benzophenone leached from the label varnish. The recall covers 10,080 bottles distributed nationwide.

    Product
    Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1423-2015·2015-09-16

    Mutual Pharmaceutical Recalls Imipramine HCl Tablets Due to Benzophenone Contamination

    Mutual Pharmaceutical is recalling 5,472 bottles of Imipramine HCl 10 mg tablets because benzophenone leached from the label varnish.

    Product
    Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3090-2015·2015-09-16

    Coloma Frozen Foods Recalls Red Tart Pitted Cherries for Elevated Mold Counts

    Coloma Frozen Foods is recalling Red Tart Pitted Cherries due to potential adulteration with elevated mold, yeast, and coliform counts.

    Product
    Red Tart Pitted Cherries, 5 Parts Fruit and 1 Part Sugar, 30 lbs. bulk pails, 15 lbs, in bulk pails
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2739-2015·2015-09-16

    Siemens ADVIA Centaur Folate Diluent Recalled for Low Recovery Results

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate Ascorbic Acid Diluent because it causes low red blood cell control recoveries and low patient sample results.

    Product
    ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3091-2015·2015-09-16

    Coloma Frozen Foods Recalls Red Tart Pitted Cherries Due to Microbial Counts

    Coloma Frozen Foods is recalling Red Tart Pitted Cherries due to potential adulteration from elevated mold, yeast, and coliform counts.

    Product
    Red Tart Pitted Cherries, Straight Packed (No Sugar), 5 lbs. bulk pails, 30 lbs, in bulk pails
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2736-2015·2015-09-16

    Medtronic Perfusion Tubing Packs Recalled for Low Ultrafiltration Performance

    Medtronic is recalling specific perfusion tubing packs and hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.

    Product
    MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2759-2015·2015-09-16

    Biomet Spine Lineum OCC Starter Flexible Instruments Recalled for Design Control Issues

    Biomet Spine is recalling Lineum OCC Starter Flexible instruments because they were distributed before design control activities were completed.

    Product
    Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·15V571000·2015-09-11

    Land Rover Recalls 2014 Range Rover Sport for Air Bag Handbook Error

    Jaguar Land Rover is recalling 5,914 vehicles because the owner's handbook incorrectly describes the Air Bag Status Indicator Lamp, potentially increasing injury risk in a crash.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3077-2015·2015-09-09

    Big Train Vanilla Chai Tea Mix Recalled for Mislabeling Sugar Content

    Big Train Inc. is recalling one lot of Vanilla Chai Tea Latte mix because it is labeled 'No Sugar Added' but actually contains sugar.

    Product
    Big Train Chai Tea Vanilla Chai, Naturally and Artificially Flavored Drink Mix, No Sugar Added, NET WT 56 oz (3 LB 8 OZ) 1.59kg lb), UPC 6 42628 10359 8. Case UPC code: 10642628103526 Soft sided 3.5 lb. pouch style package. Each case has 4 pouches.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2721-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 36 Transonic Flow Probes due to programming errors that cause incorrect meter readings.

    Product
    Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2642-2015·2015-09-09

    Customed Surgical Gowns Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling surgical gowns due to inadequate validation of sterilization processes and package integrity.

    Product
    GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2722-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect in EPROM

    Transonic Systems Inc is recalling a 6 mm Transonic Flow Probe due to a software defect causing incorrect meter readings.

    Product
    Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3070-2015·2015-09-09

    HoneyCombs Formula E Recalled for Excessive Coliform Bacteria

    HoneyCombs Industries is recalling Formula E droppers due to coliform counts exceeding specifications. The product was distributed nationwide.

    Product
    Formula E packaged in 1 FL OZ (29mL) droppers. HoneyCombs Industries, 10671 6075 Road, Montrose, CO 81403.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2487-2015·2015-09-09

    Pointe Scientific Recalls G6PD Controls Due to Reduced Stability

    Pointe Scientific is recalling G6PD Controls due to reduced reconstituted stability that may cause out-of-specification results.

    Product
    Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0417-2015·2015-09-09

    Diagnostic Hybrids Recalls MicroVue Bb Plus EIA Kits Due to Inaccurate Results

    Diagnostic Hybrids Inc is recalling 171 MicroVue Bb Plus EIA kits because they produce concentration values approximately 50% higher than expected.

    Product
    MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2539-2015·2015-09-09

    Limacorporate Recalls SMR Shoulder Trial Humeral Heads Due to Assembly Issues

    Limacorporate is recalling specific SMR Shoulder Trial Humeral Heads because their dimensions are out of specification, making them difficult to assemble.

    Product
    SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2543-2015·2015-09-09

    Roche Recalls cobas Liat Analyzers Due to Incorrect LED Components

    Roche Molecular Systems is recalling five cobas Liat Analyzers because incorrect LED components were used in the printed circuit board assemblies.

    Product
    cobas Liat Analyzer, for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    2 states