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.

20176–20200 of 21633

  • ModerateFDA (Devices)·Z-1823-2013·2013-08-07

    SteriTec EZTest Steam Biological Indicator Recalled for Labeling Inaccuracy

    SteriTec is recalling 200 units of EZTest Steam Biological Indicators because the readout time does not match the label claims.

    Product
    Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-818-2013·2013-07-31

    Oklahoma Respiratory Care Recalls Compressed Oxygen Cylinders for Purity Failures

    Oklahoma Respiratory Care Inc. is recalling 94 cylinders of compressed oxygen in Oklahoma because purity readings were out of specification.

    Product
    Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.9857, Norman, OK 73071
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1780-2013·2013-07-31

    Philips IntelliVue Smart-hopping 1.4 GHz Access Point Recalled for Signal Loss

    Philips Healthcare is recalling IntelliVue Smart-hopping 1.4 GHz Access Points due to unexpected signal loss that impacts wireless connectivity.

    Product
    Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 Part Number: 989803171211 Product Usage: IntelliVue Smart-hopping 1.4 GHz Access Point provides wireless connectivity between IntelliVue devices (listed below) and the Philips…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1725-2013·2013-07-31

    Whole Foods Recalls 365 Organic Apple Juice for Elevated Patulin Levels

    Whole Foods Market is recalling 365 Organic 100% Apple Juice due to elevated patulin levels. The recall covers 6.75 fl oz and 64 fl oz bottles distributed nationwide.

    Product
    365 Organic 100% Apple Juice from concentrate with Vitamin C and Calcium in 6.75 fl oz (UPC 0 99482 42095 6) and 64 fl oz. (UPC 0 99482 42096 3) Distributed by: Whole Foods Market, Austin, TX 78703; 8 units peer shipping case
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1781-2013·2013-07-31

    Myoscience iovera Smart Tip Recalled for Missing US Labeling Requirements

    Myoscience Inc is recalling three iovera Smart Tip units because their labels lacked required US regulatory text and symbols.

    Product
    Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1809-2013·2013-07-31

    FDA Recalls Unapproved Advanced Orthogonal Percussion Adjusting Instruments

    The FDA is recalling 54 Advanced Orthogonal Percussion Adjusting Instruments because they are unapproved medical devices. The recall covers units distributed nationwide to chiropractors.

    Product
    Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1802-2013·2013-07-31

    Becton Dickinson Recalls BBE Anaerobe Agar Due to Reduced Vancomycin

    Becton Dickinson is recalling BBE Anaerobe Laked Sheep Blood Agar plates because they may contain reduced levels of Vancomycin.

    Product
    BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1801-2013·2013-07-31

    Becton Dickinson Recalls Anaerobe Agar Plates Due to Reduced Vancomycin Levels

    Becton Dickinson is recalling specific lots of BD BBL Anaerobe CNA Agar plates because they may contain reduced levels of Vancomycin, potentially affecting test accuracy.

    Product
    BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Anaerobe Laked…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1726-2013·2013-07-31

    NOW Foods Ashwagandha Extract Recalled for Undeclared Licorice Ingredient

    NOW Foods is recalling Ashwagandha Extract capsules because they contain undeclared licorice extract. Consumers should stop using the product.

    Product
    White plastic bottle with blue cap containing 90 capsules; Ashwagandha Extract; 450 mg; CODE 4603; Manufactured by NOW FOODS; 395 S. Glen Ellyn Rd., Bloomingdale, IL 60108, USA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1804-2013·2013-07-31

    Becton Dickinson Recalls BCYE Selective Agar Plates Due to Reduced Vancomycin

    Becton Dickinson is recalling 163 cartons of BCYE Selective Agar with PAV because the media may exhibit reduced levels of Vancomycin.

    Product
    BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-824-2013·2013-07-31

    West-ward Belladonna Alkaloids with Phenobarbital Tablets Recalled for Foreign Substance

    West-Ward Pharmaceutical Corp. is recalling specific lots of Belladonna Alkaloids with Phenobarbital Tablets due to the presence of black specks comprised of degraded organic material.

    Product
    West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-812-2013·2013-07-31

    Vi-Jon Alcohol-Free Antiseptic Mouth Rinse Recalled for Microbial Contamination

    Vi-Jon, Inc. is recalling 18,408 bottles of Alcohol Free Antiseptic Mouth Rinse because a stability sample was found to be contaminated with Burkholderia contaminans.

    Product
    ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle, Distributed By The Kroger Co., Cincinnati, OH 45202, UPC 0 41260 33606 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1584-2013·2013-07-31

    Green Mountain Coffee Recalls Donut House K-Cup Packs Due to Mislabeling

    Green Mountain Coffee Roasters is recalling Donut House K-Cup packs because regular caffeinated coffee was packaged in boxes labeled as decaffeinated.

    Product
    Master Cases, Product Code #8534 (6-12 count retail boxes) Label of master case bears the name: Donut House K -Cup Packs. 12-Count Retail Boxes, Product Code #8934, Donut House Decaffeinated K-Cup Packs
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1805-2013·2013-07-31

    Becton Dickinson Recalls BBL Campylobacter CSM Agar Due to Reduced Vancomycin

    Becton Dickinson is recalling BBL Campylobacter CSM Agar because the media may exhibit reduced levels of Vancomycin.

    Product
    BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1800-2013·2013-07-31

    Becton Dickinson Recalls CDC Anaerobe Agar Plates Due to Reduced Vancomycin

    Becton Dickinson is recalling specific lots of CDC Anaerobe Agar plates because they may contain reduced levels of Vancomycin.

    Product
    BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), packaged in cartons of 100 plates, Catalog # 221736, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** CDC Anaerobe 5% Sheep…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1808-2013·2013-07-31

    Stryker Neuroform 3 Stent System Recalled for Labeling Mismatch

    Stryker Neurovascular is recalling 23 units of the Neuroform 3 Microdelivery Stent System because the model numbers on the outer carton and inner pouch labels do not match.

    Product
    Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA The Neuroform…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-815-2013·2013-07-31

    LA MER Sunscreen Recalled for Potentially Reduced Sun Protection Effectiveness

    Max Huber Research Labs is recalling LA MER SPF 18 Fluid Tint because the active ingredient avobenzone may be subpotent, potentially reducing the product's sun protection.

    Product
    LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade MEDIUM 03, UPC 7 47930 00482 0 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1799-2013·2013-07-31

    Becton Dickinson Recalls Schaedler K-V Agar Plates Due to Reduced Vancomycin

    Becton Dickinson is recalling specific lots of Schaedler K-V Agar plates because they may contain reduced levels of Vancomycin, potentially affecting test accuracy.

    Product
    BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-817-2013·2013-07-31

    Watson Recalls Diclofenac Sodium and Misoprostol Tablets Due to Broken Tablets

    Watson Laboratories is recalling Diclofenac Sodium and Misoprostol tablets because some are broken. Patients should stop using the product and contact their healthcare provider.

    Product
    DICLOFENAC SODIUM AND MISOPROSTOL — DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1784-2013·2013-07-31

    Instrumentation Laboratory Recalls HemosIL RecombiPlasTin 2G Coagulation Reagent

    Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G reagent kits due to out-of-specification quality issues. The product is used for evaluating the extrinsic coagulation pathway.

    Product
    HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1803-2013·2013-07-31

    Becton Dickinson Recalls Brucella Laked Blood Agar Due to Reduced Vancomycin

    Becton Dickinson is recalling specific lots of Brucella Laked Blood Agar because the media may contain reduced levels of Vancomycin.

    Product
    BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840, packaged in cartons of 20 plates, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Brucella Laked Blood with KV is used for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1796-2013·2013-07-31

    Haemonetics Recalls TEG 5000 Analyzers Due to Manual Errors

    Haemonetics is recalling 1,590 TEG 5000 Thromboelastograph Coagulation Analyzers because the user manual incorrectly included Research Use Only parameters.

    Product
    TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1750-2013·2013-07-31

    C. Pacific Foods Recalls Canned Mushroom Sliced Due to Pesticide Levels

    C. Pacific Foods is recalling Canned Mushroom Sliced because it contains pesticide levels not approved for this product. The recall affects 159 cartons distributed in Texas.

    Product
    Canned Mushroom Sliced 6 cans, 53oz
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1782-2013·2013-07-31

    Siemens ARTIS zee and zeego X-ray Systems Recalled for Software Issue

    Siemens is recalling 29 ARTIS zee and zeego x-ray systems due to a software issue affecting rotational 3D-acquisition programs with real-time subtraction.

    Product
    ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1771-2013·2013-07-31

    Spacelabs ARKON Anesthesia Workstation Recalled for Software Defect

    Del Mar Reynolds Medical is recalling nine Spacelabs ARKON Anesthesia Workstations due to a software defect that may cause false communication error alerts.

    Product
    Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the…
    Category
    Medical Device
    Distribution
    1 state