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.

18926–18950 of 21751

  • ModerateFDA (Devices)·Z-0930-2014·2014-02-12

    Siemens Recalls ADVIA Centaur Phenytoin Calibrator Due to Recovery Changes

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Phenytoin Calibrator N lots due to observed changes in assay recovery.

    Product
    ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0932-2014·2014-02-12

    Philips Diagnostic Imaging Systems Recalled for Database Lockup

    Philips Medical Systems is recalling 386 diagnostic imaging systems because the PET Reconstruction Server database may randomly lock up, preventing PET acquisitions and resulting in incomplete studies.

    Product
    Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Drugs)·D-1074-2014·2014-02-12

    Teva Recalls Hydralazine HCL Tablets Due to Impurity Concerns

    Teva Pharmaceuticals USA is recalling specific lots of Hydralazine HCL 25 mg tablets because they may contain impurities outside of specification limits.

    Product
    Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0554-89 (carton) and 00182-0554-00 (single blister).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1075-2014·2014-02-12

    Teva Recalls Hydralazine HCL Tablets Due to Impurity Concerns

    Teva Pharmaceuticals USA is recalling specific lots of Hydralazine HCL 50 mg tablets because they may fail impurity specifications throughout their shelf life.

    Product
    Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0555-89 (carton) and 00182-0555-00 (single…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0935-2014·2014-02-12

    Zest Anchors Recalls Locator Implant Attachment Systems Due to Labeling Error

    Zest Anchors is voluntarily recalling specific lots of Locator Implant Attachment Systems because the product labels incorrectly state the final torque for the abutment.

    Product
    LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1080-2014·2014-02-12

    Dr. Reddy's Recalls Metoprolol Succinate Tablets for Dissolution Failure

    Dr. Reddy's is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution specifications and a 12-month stability interval.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-1076-2014·2014-02-12

    Sheffield Triple Antibiotic Ointment Recalled for Microbial Contamination

    Sheffield Pharmaceuticals is recalling Sheffield Triple Antibiotic Ointment due to elevated counts of gram-positive rods found during environmental testing.

    Product
    SHEFFIELD TRIPLE ANTIBIOTIC — SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0903-2014·2014-02-12

    Stryker Neptune 2 Rover Ultra Waste Management System Field Upgrade

    Stryker is upgrading Neptune 2 Rover Ultra Waste Management Systems in the field to meet new 510(k) clearance specifications.

    Product
    Neptune 2 Rover Ultra Waste Management System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0933-2014·2014-02-12

    Stryker Recalls Gaymar Medi-Therm Devices Due to Missing Water Temperature Display

    Stryker is recalling 1,002 Gaymar Medi-Therm devices because the water temperature display is blank in Auto mode, potentially preventing users from verifying water temperature.

    Product
    The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0906-2014·2014-02-12

    Exactech Recalls InteGrip Acetabular Augments Due to Biological Evaluation Failure

    Exactech is recalling 235 units of InteGrip Acetabular Augments because an in-vitro biological evaluation standard was out of range.

    Product
    ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-1060-2014·2014-02-12

    Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Broken Tablets

    Actavis Inc is recalling 6,540 bottles of Diclofenac Sodium and Misoprostol tablets because some tablets are broken.

    Product
    DICLOFENAC SODIUM AND MISOPROSTOL — DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1077-2014·2014-02-12

    FAMILY wellness Triple Antibiotic Ointment Recalled for Microbial Contamination

    Faria Limited LLC is recalling FAMILY wellness Triple Antibiotic Ointment due to elevated counts of gram-positive rods found during environmental testing.

    Product
    FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0904-2014·2014-02-12

    Horiba Medical Recalls ABX PENTRA N Control for Revised Potassium Values

    Horiba Medical is recalling ABX PENTRA N Control units because the product was updated to include a revised Target Value assignment for Potassium.

    Product
    ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0934-2014·2014-02-12

    OrthoPediatrics Recalls 3.5mm Locking Cortical Bone Screws Due to Packaging Error

    OrthoPediatrics is recalling 12 units of 3.5mm Locking Cortical Bone Screws because the packages incorrectly contain non-locking screws.

    Product
    3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0922-2014·2014-02-12

    Highland Metals Recalls SuperElastic NiTi Archwires Due to Labeling Errors

    Highland Metals, Inc. is recalling SuperElastic NiTi archwires because some packages labeled 'Upper' contain 'Lower' archwires and vice versa.

    Product
    SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0923-2014·2014-02-12

    Highland Metals Recalls SuperElastic NiTi Orthodontic Archwires Due to Labeling Errors

    Highland Metals, Inc. is recalling SuperElastic NiTi orthodontic archwires because some packages are mislabeled, potentially containing the wrong arch type.

    Product
    SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-1062-2014·2014-02-12

    Children's Ibuprofen Recalled for Abnormal Appearance and Discoloration

    Central Shared Services dba Parallon is recalling 3,764 cups of Children's Ibuprofen Oral Suspension due to discoloration and failure to meet appearance specifications.

    Product
    CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1079-2014·2014-02-12

    Corepharma Recalls Pyridostigmine Bromide Tablets Due to Dissolution Failure

    Corepharma LLC is recalling Pyridostigmine Bromide Tablets USP 60 mg because they failed a dissolution test at the 30-month stability time point.

    Product
    Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC Middlesex, NJ 08846, NDC 64720-128-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1064-2014·2014-02-12

    Forest Pharmaceuticals Recalls Namenda XR Capsules for Dissolution Failures

    Forest Pharmaceuticals is recalling 3,950 packs of Namenda XR titration packs because they failed stability dissolution testing.

    Product
    Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in 28-capsule, 4 week, titration pack,Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3400-29.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0909-2014·2014-02-12

    Nipro Diagnostics Recalls Blood Glucose Monitors With Incorrect Factory Settings

    Nipro Diagnostics is recalling 501 units of the MooreBrand TRUEbalance Blood Glucose Monitor because they were manufactured with an incorrect factory set unit of measure.

    Product
    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0910-2014·2014-02-12

    Nipro Diagnostics Recalls TRUEtrack Blood Glucose Monitors Due to Unit Error

    Nipro Diagnostics is recalling 105 TRUEtrack blood glucose monitors because they were manufactured with an incorrect factory set unit of measure.

    Product
    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0842-2014·2014-02-05

    Biomerieux Recalls API Listeria Kits Due to ZYM B Reagent Defect

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

    Product
    API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1439-2014·2014-02-05

    Atlapac Recalls Swollen California Girl Canned Peach Halves

    Atlapac Trading Company is recalling California Girl canned Peach Halves in Juice because the cans were reported to be swollen.

    Product
    California Girl canned Peach Halves in Juice, 6 cans per case. UPC 52391 72992
    Category
    Food
    Distribution
    1 state