The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

976–1000 of 2769

  • LowFDA (Devices)·Z-2332-2018·2018-07-11

    Ecolab Microtek Rolled Probe Cover Recalled for Incorrect Instructions

    Ecolab Inc. is recalling 65 cases of Microtek Rolled Probe Covers because they were shipped with incorrect instructions for use.

    Product
    ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body flui
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-2377-2018·2018-07-11

    Medtronic MiniMed Paradigm Veo Insulin Pump Recalled for Arabic Translation Error

    Medtronic is recalling 239,859 MiniMed Paradigm Veo insulin pumps due to an error in the Arabic language translation of the Predictive Alerts setting screen.

    Product
    Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
    Category
    Medical Device
    Distribution
    0 states
  • LowUSDA FSIS·059-2018·2018-07-06

    Tillamook Country Smoker Recalls Teriyaki Beef Jerky Due to Misbranding

    Tillamook Country Smoker is recalling approximately 102 pounds of teriyaki beef jerky because the products may contain undeclared monosodium glutamate (MSG).

    Product
    Tillamook Country Smoker, LLC — Recall Notification Report 059-2018 (Beef Jerky Products)
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-1592-2018·2018-07-04

    Absonutrix Recalls Vitamin B12 Supplement Lacking Listed Ingredient

    Absonutrix is recalling Lyfetrition Vitamin B12 supplements because the product did not contain the vitamin listed on the label.

    Product
    Lyfetrition Live Life Nutritiously Vitamin B12 2 FL. OZ bottle Supplement Facts Serving Size:***Vitamin B-12 (as Methylcobalamyn) ABSONUTRIX 5500 Adams Farm Lane, Suite 206 Greensboro NC 27407 UPC 7 00443 88822 6
    Category
    Food
    Distribution
    22 states
  • LowFDA (Food)·F-1621-2018·2018-07-04

    McEvoy Ranch Extra Virgin Olive Oil Recalled for Cracking Bottles

    McEvoy of Marin, LLC. is recalling 6,000 bottles of 1-liter McEvoy Ranch 100% Certified Extra Virgin Olive Oil because inconsistent filling caused bottles to crack and break.

    Product
    McEvoy Ranch 100% Certified Extra VirginOlive Oil; Made in California; 1 L, 33,8 FL OZ UPC 6 34832 00291
    Category
    Food
    Distribution
    0 states
  • LowFDA (Drugs)·D-0887-2018·2018-06-27

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures

    Dr. Reddy's Laboratories is recalling specific lots of Atorvastatin Calcium tablets because they failed impurity and degradation specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2257-2018·2018-06-27

    Quantimetrix Recalls Dropper Plus Urinalysis Control Kits Due to Lot Error

    Quantimetrix Corporation is recalling 20 kits of Dropper Plus Point-of-Care Urinalysis Dipstick Control because they contained an incorrect lot of Level 1 vials.

    Product
    Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory
    Category
    Medical Device
    Distribution
    1 state
  • LowUSDA FSIS·054-2018·2018-06-25

    Land O'Frost Recalls 4,944 Pounds of Misbranded Black Forest Ham

    Land O'Frost is recalling 4,944 pounds of Black Forest Ham because the back of the package incorrectly identifies the product as Honey Smoked Turkey Breast.

    Product
    Land O'Frost, Inc. — Recall Notification Report 054-2018 (Ham Products)
    Category
    Food
    Distribution
    5 states
  • LowFDA (Drugs)·D-0877-2018·2018-06-20

    Mylan Recalls Maxzide-25 Tablets Due to Slightly High Potency

    Mylan Pharmaceuticals is recalling 1,620 bottles of Maxzide-25 tablets because routine stability testing showed potency slightly above specification.

    Product
    Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-2140-2018·2018-06-20

    Immunalysis Recalls EDDP Urine Control Set Due to Specification Failure

    Immunalysis is recalling 37 kits of EDDP Urine Control Set 1 because the High control fails to meet specifications, potentially producing inaccurate test results.

    Product
    lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result
    Category
    Medical Device
    Distribution
    14 states
  • LowFDA (Devices)·Z-2106-2018·2018-06-13

    Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

    Datascope Corporation is recalling 19 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that causes monitor errors.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-2105-2018·2018-06-13

    Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

    Datascope is recalling 194 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that triggers a monitor error.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-2104-2018·2018-06-13

    Datascope Cardiopulmonary Bypass Tubing Kit Recalled for Cuvette Failure

    Datascope is recalling 19 cardiopulmonary bypass tubing kits due to a potential cuvette failure that causes monitor error messages.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-2047-2018·2018-06-13

    Draeger Jaundice Meter JM-105 Recalled for Misinterpreted Display Readings

    Draeger Medical Systems is recalling 6,711 Draeger Jaundice Meter JM-105 devices because users may misinterpret the out-of-range display as a zero measurement.

    Product
    Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2046-2018·2018-06-13

    Draeger Jaundice Meter JM-103 Recalled for Measurement Display Misinterpretation

    Draeger Medical Systems is recalling the Jaundice Meter JM-103 because users may misinterpret the out-of-range display as a zero measurement.

    Product
    Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0836-2018·2018-06-06

    Lupin Recalls Hydrocodone and Acetaminophen Tablets for Missing Labels

    Lupin Pharmaceuticals is recalling 1,672 bottles of Hydrocodone Bitartrate and Acetaminophen tablets in Ohio due to missing labels.

    Product
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN — HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN)
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-1907-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 47 units of Legion CR XLPE Articular Inserts due to a packaging error where inner and outer pouches were sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1906-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling Legion CR XLPE High Lexion Articular Inserts due to a packaging error where inner and outer pouches were sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1905-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 72 units of Legion CR XLPE Articular Inserts because the inner and outer packaging pouches were inadvertently sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0857-2018·2018-05-30

    Teva Recalls Lidocaine Patches Due to Failed Stability Specifications

    Teva Pharmaceuticals USA is recalling Lidocaine Patch 5% products because they failed stability specifications. The recall covers 30,382 patches distributed in the United States.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0832-2018·2018-05-30

    Milbar Recalls Subpotent Coal Tar Shampoo for Hair and Body

    Milbar Laboratories is voluntarily recalling 952 bottles of T Shampoo For Hair and Body because the product is subpotent.

    Product
    T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-1920-2018·2018-05-30

    Implant Direct Legacy 4 Implant Recalled for Mislabeling

    Implant Direct Sybron Manufacturing is recalling 18 units of Legacy 4 Implants due to a mislabeled vial cap. The main label was correct, but the cap showed the wrong part number.

    Product
    ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
    Category
    Medical Device
    Distribution
    10 states