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.

12676–12700 of 21617

  • ModerateFDA (Drugs)·D-0807-2017·2017-05-31

    Advanced Pharma Recalls TPN Products Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling TPN products because they may contain latex but lack proper labeling.

    Product
    ADD HEPARIN PF 50 Units ONLY TO TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2128-2017·2017-05-31

    Teleflex Medical Recalls PE Connector 3/8 Y 20/BX Due to Missing Expiration Date

    Teleflex Medical is recalling 19,043 units of PE Connector 3/8 Y 20/BX because the expiration date is missing from the labeling, creating a risk of using expired product.

    Product
    PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0827-2017·2017-05-31

    Advanced Pharma Recalls Norepinephrine Bitartrate for Latex Labeling

    Advanced Pharma Inc. is recalling all lots of Norepinephrine Bitartrate because the product may contain synthetic or natural latex, which is not currently disclosed on the label.

    Product
    Norepinephrine Bitartrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0795-2017·2017-05-31

    Advanced Pharma Recalls Ropivacaine HCl Injection Due to Latex Labeling

    Advanced Pharma Inc. is recalling Ropivacaine HCl in 0.9% Sodium Chloride because the product may contain synthetic or natural latex, which is not currently classified in the labeling.

    Product
    Ropivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0797-2017·2017-05-31

    Advanced Pharma Recalls Nalbuphine Due to Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all lots of Nalbuphine because the product labeling fails to disclose that it may contain synthetic or natural latex.

    Product
    Nalbuphine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0815-2017·2017-05-31

    Advanced Pharma Recalls Lorazepam HCl Due to Latex Labeling

    Advanced Pharma Inc. is recalling all lots of Lorazepam HCl because the product may contain synthetic or natural latex, which is not currently labeled.

    Product
    Lorazepam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0853-2017·2017-05-31

    Advanced Pharma Recalls Fentanyl and Bupivacaine Products for Latex Labeling

    Advanced Pharma Inc. is recalling Fentanyl Citrate and Bupivacaine HCl products because labeling may not disclose the presence of synthetic or natural latex.

    Product
    Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2051-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Software and Hardware Update Recall

    St. Jude Medical is updating software and hardware for HeartMate II LVAS devices to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0802-2017·2017-05-31

    Advanced Pharma Recalls NICU Starter TPN Due to Latex Labeling

    Advanced Pharma Inc. is recalling NICU Starter TPN products because they may contain synthetic or natural latex without proper labeling.

    Product
    NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0818-2017·2017-05-31

    Advanced Pharma Recalls Vancomycin HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Vancomycin HCl because the product may contain latex but lacks appropriate labeling.

    Product
    Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0809-2017·2017-05-31

    Advanced Pharma Recalls Fentanyl Citrate Due to Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all lots of Fentanyl Citrate because the product labeling does not indicate that it may contain synthetic or natural latex.

    Product
    Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0811-2017·2017-05-31

    Advanced Pharma Recalls Meperidine HCl for Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all lots of Meperidine HCl because the product labeling does not indicate that it may contain synthetic or natural latex.

    Product
    Meperidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2159-2017·2017-05-31

    MesaLabs Conductivity Standard Solution Recalled for Specification Failure

    Mesa Laboratories is recalling 9,900 units of Conductivity/TDS Calibrator Solution because the product failed to meet specifications. The solution is used for calibrating hemodialysis equipment and does not contact patients.

    Product
    MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0823-2017·2017-05-31

    Advanced Pharma Recalls 0.9% Sodium Chloride Slip Tip for Latex Labeling

    Advanced Pharma Inc. is recalling 0.9% Sodium Chloride Slip Tip products because they may contain latex without proper labeling.

    Product
    0.9% Sodium Chloride Slip Tip all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0822-2017·2017-05-31

    Advanced Pharma Recalls Heparin Sodium Due to Latex Labeling

    Advanced Pharma Inc. is recalling all strengths and dosage forms of Heparin sodium because the product may contain synthetic or natural latex without proper labeling.

    Product
    Heparin sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0850-2017·2017-05-31

    Advanced Pharma Recalls Sodium Phosphate for Latex Labeling Defect

    Advanced Pharma Inc. is recalling Sodium Phosphate products because they may contain latex but lack proper labeling. The recall covers all strengths and dosage forms distributed nationwide.

    Product
    Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2126-2017·2017-05-31

    BioMerieux Recalls Ceftriaxone ETEST Kits Due to Performance Issues

    BioMerieux SA is recalling Ceftriaxone ETEST kits due to a potential performance issue affecting strain categorization.

    Product
    Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0829-2017·2017-05-31

    Advanced Pharma Recalls Calcium Gluconate for Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling Calcium Gluconate products because they may contain latex without proper labeling.

    Product
    Calcium Gluconate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0851-2017·2017-05-31

    Advanced Pharma Recalls Sodium Citrate Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all strengths and dosage forms of Sodium Citrate because the product may contain latex without proper labeling.

    Product
    Sodium Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2156-2017·2017-05-31

    Siemens AXIOM Sensis Diagnostic Computer Recalled for Dust-Related Failures

    Siemens Medical Solutions is recalling 4,095 AXIOM Sensis diagnostic computers because dust accumulation can cause system failures, potentially interrupting clinical treatments.

    Product
    AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0849-2017·2017-05-31

    Advanced Pharma Recalls Potassium Phosphate Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all strengths and dosage forms of Potassium Phosphate because the product may contain latex but lacks proper labeling.

    Product
    Potassium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2053-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update

    St. Jude Medical is providing software and hardware updates to HeartMate II LVAS Pocket Controllers to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0847-2017·2017-05-31

    Advanced Pharma Recalls Cardioplegic Solution for Latex Labeling Defect

    Advanced Pharma Inc. is recalling Cardioplegic Solution Maintenance due to a labeling error regarding potential latex content.

    Product
    Cardioplegic Solution Maintenance all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0814-2017·2017-05-31

    Advanced Pharma Recalls Midazolam HCl for Potential Latex Content

    Advanced Pharma Inc. is recalling all lots of Midazolam HCl because the product may contain synthetic or natural latex.

    Product
    Midazolam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0813-2017·2017-05-31

    Advanced Pharma Recalls Ketamine HCl for Potential Latex Content

    Advanced Pharma Inc. is recalling all lots of Ketamine HCl because the product may contain synthetic or natural latex.

    Product
    Ketamine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide