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.

10001–10025 of 21617

  • ModerateFDA (Devices)·Z-3182-2018·2018-09-26

    Mako Surgical Recalls RIO Standard System Components for Connection Errors

    Mako Surgical Corporation is recalling 910 units of the Makoplasty RIO Standard System and Ethernet to Fiber Optic Converter due to communication-connection errors.

    Product
    Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3187-2018·2018-09-26

    Tecan Freedom EV0-2 Software Recall for Sample Tracking Issues

    Tecan US, Inc. is recalling Freedom EV0-2 devices with EVOware Sample Tracking Add-On V1.0 or higher due to a software issue that can impact sample identification and traceability.

    Product
    Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1197-2018·2018-09-26

    Beaumont Bio-Med Recalls Allergy & Hay Fever Relief Homeopathic Formula

    Beaumont Bio-Med is recalling 124 bottles of Allergy & Hay Fever Relief Homeopathic Formula due to CGMP deviations that could result in possible microbial contamination.

    Product
    Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7011-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1196-2018·2018-09-26

    Beaumont Bio-Med Recalls Muscle & Joint Pain Relief Spray for CGMP Deviations

    Beaumont Bio-Med, Inc. is recalling 109 bottles of Muscle & Joint Pain Relief Homeopathic Formula due to CGMP deviations that could result in possible microbial contamination.

    Product
    Muscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7041-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3008-2018·2018-09-26

    Ventana ISH iView Blue Detection Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling 559 units of the ISH iView Blue Detection Kit because the reagent dispensers may leak or stick.

    Product
    VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3197-2018·2018-09-26

    Arrow Bipolar Electrode Catheter Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc. is recalling 7 units of a specific bipolar electrode catheter lot because they are labeled with an incorrect expiration date.

    Product
    ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3001-2018·2018-09-26

    Ventana iView DAB Detection Kit Recalled for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling iView DAB Detection Kits because leaking and sticking dispensers may cause false negative IHC results.

    Product
    iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3199-2018·2018-09-26

    Arrow International Recalls PICC Kits Due to Incorrect Catheter Inclusion

    Arrow International is recalling specific PICC kits because they may contain the wrong catheter type, potentially delaying patient treatment.

    Product
    4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-1199-2018·2018-09-26

    Beaumont Bio-Med Recalls Arthritis Pain Relief Spray Due to CGMP Deviations

    Beaumont Bio-Med is recalling 140 bottles of Arthritis Pain Relief Homeopathic Formula due to manufacturing conditions that could result in microbial contamination.

    Product
    Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7042-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3176-2018·2018-09-26

    Zimmer Biomet Recalls Commingled Gentle Thread PLGA Interference Screws

    Zimmer Biomet is recalling 52 Gentle Thread PLGA Round Head Interference Screws because they were commingled with a different screw size.

    Product
    Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1194-2018·2018-09-26

    Beaumont Bio-Med Recalls Sore Throat Homeopathic Spray Due to CGMP Deviations

    Beaumont Bio-Med is recalling Sore Throat & Laryngitis Response Homeopathic Formula due to manufacturing deviations that could result in microbial contamination.

    Product
    Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7014-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1192-2018·2018-09-26

    Beaumont Bio-Med Recalls Skin Irritation Homeopathic Spray Due to CGMP Deviations

    Beaumont Bio-Med is recalling Skin Irritation & Itch Response Homeopathic Formula due to manufacturing deviations that could result in possible microbial contamination.

    Product
    Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7002-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1195-2018·2018-09-26

    Beaumont Bio-Med Recalls Diarrhea Response Homeopathic Formula Due to CGMP Deviations

    Beaumont Bio-Med, Inc. is recalling 160 bottles of Diarrhea Response Homeopathic Formula due to manufacturing deviations that could result in microbial contamination.

    Product
    Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7022-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2767-2018·2018-09-26

    Foley Catheter with Temperature Sensor Recalled for Defective Sensors

    Degania Silicone is recalling 12,532 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3185-2018·2018-09-26

    Polymedco PATHFAST Myoglobin II Cartridges Recalled for Leakage

    Polymedco is recalling 272 PATHFAST Myoglobin II reagent cartridges due to a pinhole defect that may cause measurement bias.

    Product
    PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3189-2018·2018-09-26

    Siemens Artis Q X-Ray Systems Recalled for Temperature Control Defect

    Siemens is recalling 429 Artis Q Interventional Fluoroscopic X-Ray Systems because a temperature control defect may cause the detector to cool down outside its designed working range.

    Product
    Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3179-2018·2018-09-26

    bioMerieux Recalls VITEK 2 AST-P640 Cards Due to Gentamicin Error

    bioMerieux is recalling VITEK 2 AST-P640 cards because some lots contain insufficient gentamicin, potentially affecting high-level resistance test results.

    Product
    VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3198-2018·2018-09-26

    Biocare Medical Recalls URO-3 Triple Stain Kits Due to Component Mislabeling

    Biocare Medical is recalling 11 URO-3 Triple Stain kits because two components were mislabeled, causing incorrect staining patterns in laboratory tests.

    Product
    URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062AA, Package Type: Bottle Product Usage: URO-3 Triple Stain (CD44 + p53) with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3200-2018·2018-09-26

    Arrow International Recalls PICC Kits Due to Incorrect Catheter Type

    Arrow International is recalling 5.5 Fr x 5.5 Fr x 40 cm double-lumen PICC Kits because they may contain the wrong catheter type, potentially delaying treatment.

    Product
    5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-3190-2018·2018-09-26

    Siemens ARTIS Pheno X-Ray System Recalled for Temperature Control Defect

    Siemens is recalling 429 ARTIS Pheno Interventional Fluoroscopic X-Ray Systems because a temperature control defect may cause the detector to cool below its designed operating range.

    Product
    ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1198-2018·2018-09-26

    Beaumont Bio-Med Recalls Colds & Flu Response Homeopathic Formula

    Beaumont Bio-Med is recalling Colds & Flu Response Homeopathic Formula due to potential microbial contamination from manufacturing deviations.

    Product
    Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7012-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1965-2018·2018-09-26

    Blommer Natural Cocoa Butter Bulk Tanker Recalled for Process Deviation

    Blommer Chocolate Co. is recalling 95,040 lbs of Natural Cocoa Butter Bulk Tanker due to a critical process deviation. The product was distributed in Illinois and New Jersey.

    Product
    Blommer Natural Cocoa Butter Bulk Tanker
    Category
    Food
    Distribution
    2 states
  • ModerateUSDA FSIS·083-2018·2018-09-21

    Junior's Smokehouse Recalls Beef Jerky Due to Metal Contamination

    Junior's Smokehouse is recalling teriyaki beef jerky produced in August 2018 due to possible hard metal contamination. No illnesses have been reported.

    Product
    Junior's Smokehouse Processing Plant — Junior's Smokehouse Processing Plant Recalls Beef Jerky Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state