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.

20576–20600 of 21633

  • ModerateFDA (Devices)·Z-1141-2013·2013-04-24

    Horiba ABX PENTRA 400 I.S.E. Module Recalled for Missing Linearity Flags

    Horiba Medical is recalling ABX PENTRA 400 I.S.E. Modules because the software lacks Linearity Limit Flags for I.S.E. assays, which may prevent users from detecting out-of-range values.

    Product
    HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-257-2013·2013-04-24

    Pfizer Recalls Levoxyl Tablets Due to Strong Odor Contamination

    Pfizer is recalling Levoxyl (levothyroxine sodium) tablets because they emit a strong odor after the package is opened.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1110-2013·2013-04-24

    Intuitive Surgical da Vinci System User Manual Recall for Sterile Adapter Instructions

    Intuitive Surgical is recalling IS3000 user manuals for da Vinci Si and Si-e systems to provide revised instructions for sterile adapter engagement and instrument installation.

    Product
    IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1330-2013·2013-04-24

    Trader Joe's Three Layer Hummus Dip Recalled for Foreign Material

    Two Chefs on a Roll is recalling Trader Joe's Three Layer Hummus Dip because it may contain small pieces of food-grade equipment.

    Product
    Trader Joe's Three Layer Hummus Dip 12 oz., 12 units/case, SKU 80867.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1109-2013·2013-04-24

    Intuitive Surgical Recalls da Vinci S User Manual for Sterile Adapter Instructions

    Intuitive Surgical is recalling IS2000 user manuals for the da Vinci S system to provide revised instructions on sterile adapter engagement and instrument installation.

    Product
    IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1329-2013·2013-04-24

    Trader Joe's Hummus Dip Recalled for Foreign Material Contamination

    Two Chefs On A Roll is recalling Trader Joe's Hummus Dip because it may contain small pieces of food grade equipment.

    Product
    Trader Joe's Hummus Dip Size: 16 oz., 12 units/case, SKU 20411. Size: 7 oz, 24 units/case, SKU 15735.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1118-2013·2013-04-24

    Abbott Recalls Phenobarbital Reagent Lots Due to Imprecision Issues

    Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots due to imprecision issues that increase with the age of the reagent.

    Product
    Clinical Chemistry Phenobarbital, list number 1E08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1104-2013·2013-04-24

    Toshiba Diagnostic Ultrasound Systems Recalled for Startup Issues

    Toshiba is recalling 233 Aplio 500/400/300 diagnostic ultrasound systems due to startup issues that may cause system damage.

    Product
    Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-250-2013·2013-04-24

    Precision Dose Recalls Children's Acetaminophen Due to Misleading Labeling

    Precision Dose Inc. is recalling Children's Acetaminophen Oral Suspension because the label is misleading. The product contains an adult dose of acetaminophen despite the name.

    Product
    Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1337-2013·2013-04-24

    Trader Joe's Hummus Salad Dressing Recalled for Foreign Material

    Two Chefs on a Roll is recalling Trader Joe's Hummus Salad Dressing because it may contain small pieces of food grade equipment.

    Product
    Trader Joe's Hummus Salad Dressing 12 oz., 12 units/case, SKU 96752.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1106-2013·2013-04-24

    Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry Systems

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because extension springs may be out of specification, potentially causing imprecise test results.

    Product
    VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. Intended for use in the measurement of a variety of chemistry analytes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1140-2013·2013-04-24

    Nipro TRUEtrack Blood Glucose Monitor Kits Recalled for Labeling Error

    Nipro Diagnostics is recalling 1,627 TRUEtrack monitor kits because the outer boxes state an incorrect storage temperature range for the test strips.

    Product
    Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1336-2013·2013-04-24

    Trader Joe's Mediterranean Hummus Recalled for Foreign Material

    Two Chefs On A Roll is recalling Trader Joe's Mediterranean Hummus Snack Packs because they may contain small pieces of food-grade equipment material.

    Product
    Trader Joe's Mediterranean Hummus Snack Pack with Pita Chips 8 oz., 24 units/case, SKU 97136.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-252-2013·2013-04-24

    Pfizer Recalls Levoxyl Tablets Due to Chemical Odor Contamination

    Pfizer is recalling Levoxyl (levothyroxine sodium) tablets because they emit a strong odor after the package is opened.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1334-2013·2013-04-24

    Trader Joe's Tomato Basil Hummus Dip Recalled for Foreign Material

    Two Chefs On A Roll is recalling Trader Joe's Tomato Basil Hummus Dip because it may contain small pieces of food-grade equipment.

    Product
    Trader Joe's Tomato Basil Hummus Dip 7 oz., 24 units/case, SKU 21953.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1122-2013·2013-04-24

    Siemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Calibrators due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1335-2013·2013-04-24

    Trader Joe's Chunky Olive Hummus Recalled for Foreign Material

    Two Chefs On A Roll is recalling Trader Joe's Chunky Olive Hummus because it may contain small pieces of food grade equipment.

    Product
    Trader Joe's Chunky Olive Hummus 7 oz., 24 units/case, SKU 75347.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-256-2013·2013-04-24

    Pfizer Recalls Levoxyl Tablets Due to Strong Odor Emission

    Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong odor after the package is opened.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-259-2013·2013-04-24

    Pfizer Recalls Levoxyl Tablets Due to Chemical Odor Contamination

    Pfizer is recalling specific lots of Levoxyl (levothyroxine sodium) tablets because they emit a strong chemical odor after the package is opened.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1003-2013·2013-04-24

    Philips Healthcare Recalls CT Systems Due to Inaccurate Dose Measurements

    Philips Healthcare is recalling CT systems because CTDI measurements were 15 to 25% higher than protocol parameters.

    Product
    Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1326-2013·2013-04-24

    Siya Green Mukwhas Recalled for Unapproved and Undeclared Colors

    Miami Growers, Inc. is recalling Siya Green Mukwhas because the product contains unapproved and undeclared colors.

    Product
    Siya Green Mukwhas Net Wt. 200 gm (7 oz) Distributed by: Miami Growers, Inc. 80 Broadway, Jersey City, NJ 07306 Phone: 201-985-9322, Fax: 201-985-9569 Email: [email protected] Visit us: www.miamigrowersinc.com A Product of India
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1139-2013·2013-04-24

    Alere Cholestech LDX ALT AST Test Cassette Recalled for Humidity Impact

    Alere San Diego is recalling 38,571 ALT AST test cassettes because humidity changes may impact test results.

    Product
    Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-251-2013·2013-04-24

    Pfizer Recalls Levoxyl Tablets Due to Chemical Odor

    Pfizer is recalling Levoxyl (levothyroxine sodium) tablets because they emit a strong odor after the package is opened.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1119-2013·2013-04-24

    Siemens ADVIA Centaur Vitamin D Assay Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Assay kits due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
    Category
    Medical Device
    Distribution
    Distributed nationwide