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.

18476–18500 of 21645

  • ModerateFDA (Devices)·Z-1489-2014·2014-04-30

    Ev3 Recalls EverCross PTA Dilatation Catheters Due to Labeling Error

    Ev3 is recalling two lots of EverCross PTA Dilatation Catheters because of a discrepancy in the balloon and delivery catheter lengths printed on the product labeling.

    Product
    ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1479-2014·2014-04-30

    Hospira Recalls HemoSet IV Sets Due to Incorrect Lower Lid Component

    Hospira is recalling 3,893 HemoSet IV sets because an incorrect lower lid was used during manufacturing, which changes the drop rate from 15 to 10 drops per mL.

    Product
    LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Infusers.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1486-2014·2014-04-30

    Merit Medical Recalls Hydrophilic Guide Wires Due to Labeling Discrepancy

    Merit Medical Systems is voluntarily recalling specific lots of Laureate Hydrophilic Guide Wires due to a discrepancy between carton and unit labeling.

    Product
    Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1243-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenges Due to Quality Failures

    GlaxoSmithKline is recalling Nicorette 4 mg lozenges because they failed specifications for thickness, softness, and potency.

    Product
    Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1497-2014·2014-04-30

    Teleflex Medical Recalls Non-absorbable Steel Sutures for Diameter Defects

    Teleflex Medical is recalling specific lots of non-absorbable steel sutures because they did not meet minimum diameter requirements.

    Product
    Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1496-2014·2014-04-30

    Zimmer Trabecular Metal Hip Implant Shell Recalled for Missing Locking Ring

    Zimmer, Inc. is recalling 17 units of Trabecular Metal Modular Acetabular System shells because the locking ring was missing.

    Product
    TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1485-2014·2014-04-30

    Merit Medical Recalls Mixed Hydrophilic Guide Wire Lots

    Merit Medical Systems is recalling 173 units of Laureate Hydrophilic Guide Wire due to a labeling discrepancy where the product was mixed with a different lot.

    Product
    Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1499-2014·2014-04-30

    Meta Labs Recalls Mega-Gen Personal Lubricant Due to Unregistered Manufacturer

    Altasource LLC is recalling Mega-Gen His and Hers Personal Lubricant because the firm is not registered as a drug manufacturer.

    Product
    Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1475-2014·2014-04-30

    BioMerieux Recalls ZYM B Reagent Due to Visual Defect and Activity Issue

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

    Product
    ZYM B Reagent (REF 70493). The 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 (Devices)·Z-1504-2014·2014-04-30

    Siemens ACUSON X700 Ultrasound Systems Recalled for Data Error

    Siemens is recalling 490 ACUSON X700 ultrasound systems because previous patient data may replace current patient dates in reports.

    Product
    Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1491-2014·2014-04-30

    Abbott Molecular Recalls CEP 8 Probe Kits Containing Incorrect Probe

    Abbott Molecular is recalling 20 kits of CEP 8 SG ASR Probe that contained the wrong probe. The kits contained Vysis CEP 4 probe instead of the expected CEP 8 probe.

    Product
    The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1240-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling specific lots of Nicorette 4 mg lozenges because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

    Product
    NICORETTE — NICORETTE (NICOTINE POLACRILEX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1241-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling specific lots of Nicorette 2 mg lozenges because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

    Product
    NICORETTE — NICORETTE (NICOTINE POLACRILEX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1246-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling specific lots of Nicorette lozenges because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

    Product
    NICORETTE — NICORETTE (NICOTINE POLACRILEX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1501-2014·2014-04-30

    Meta Labs Recalls Hot Ice Topical Gel Due to Unregistered Manufacturer

    Altasource LLC dba Meta Labs LLC is recalling 155 units of Hot Ice topical gel because the firm is not registered as a drug manufacturer.

    Product
    Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens secual excitement and pleasure.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1498-2014·2014-04-30

    FDA Recalls Amo-O Herbal Stimulator Gel for Unregistered Manufacturer

    Altasource LLC is recalling 70 units of Amo-O Herbal Stimulator gel because the firm is not registered as a drug manufacturer.

    Product
    Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA 30076, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1477-2014·2014-04-30

    BioMerieux Recalls ZYM B and FB Reagents Due to False Negative Results

    BioMerieux is recalling ZYM B and FB reagents because a visual defect and activity issue can cause false negative results in Rapid ID 32 strips and API biochemical tests.

    Product
    API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1239-2014·2014-04-30

    GlaxoSmithKline Recalls Nicotine Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling Nicorette and store-brand nicotine lozenges because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

    Product
    Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1508-2014·2014-04-30

    Branan Medical ToxCup Drug Screen Cups Recalled for Labeling Errors

    Branan Medical is recalling ToxCup Drug Screen Cups because the lid labels may contain incorrect result interpretation graphics.

    Product
    ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1502-2014·2014-04-30

    Varian On-Board Imager Elbow Motor Shaft Recall

    Varian Medical Systems is recalling On-Board Imager devices with Type 01 elbow motors due to a shaft failure caused by belt over-tensioning.

    Product
    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1487-2014·2014-04-30

    Boston Scientific Recalls iLab Ultrasound Systems Due to Measurement Error

    Boston Scientific is recalling 9 iLab Ultrasound Imaging Systems because a software update may cause the Longview distance measurement to display double the actual value.

    Product
    iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1238-2014·2014-04-30

    GlaxoSmithKline Recalls Nicotine Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling Nicorette and store-brand nicotine lozenges because they failed specifications for thickness, softness, and potency.

    Product
    Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1490-2014·2014-04-30

    Ortho-Clinical VITROS Chemistry Calibration Data Module Recalled for Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CDM PROM No. 0168 because it lacks calibration parameters for DT CRSC slides, preventing system calibration.

    Product
    VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1494-2014·2014-04-30

    Arrow Pressure Injectable PICC Catheter Recall Due to Incorrect Length

    Arrow International Inc. is recalling 789 units of Arrow Pressure Injectable PICC catheters because they contain a 40cm catheter instead of the required 50cm catheter.

    Product
    Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide