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.

751–775 of 2738

  • LowCPSC·19755·2019-06-28

    Yamaha Recalls Grizzly ATVs and Wolverine X2 ROVs for Incorrect Manuals

    Yamaha is recalling about 1,500 Grizzly ATVs and Wolverine X2 ROVs because the owner's manuals contain information for the wrong models.

    Product
    Yamaha Grizzly ATVs and Wolverine X2 Side-by-Side Vehicles (ROV)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1843-2019·2019-06-26

    Cytocell Aquarius D13S319 Probe Recalled for Package Insert Error

    Cytocell Ltd. is recalling Aquarius D13S319 Plus Deletion Probes because the chromomap on the package insert contains an error.

    Product
    Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1392-2019·2019-06-26

    Akorn Recalls Myorisan Isotretinoin Capsules Due to Labeling Error

    Akorn Inc. is recalling 16,216 cartons of Myorisan isotretinoin capsules because secondary cartons incorrectly state 40 mg instead of 30 mg.

    Product
    Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1804-2019·2019-06-26

    Arrow JACC Central Catheter Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 12 units of JACC central catheters because the expiration date printed on the packaging is incorrect.

    Product
    Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillosubclavian Central Catheter Product Code: CDC 43063 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1802-2019·2019-06-26

    Arrow JACC Central Catheter Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 6 units of Arrow JACC Central Catheters because the expiration date is incorrect.

    Product
    Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42552 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1391-2019·2019-06-26

    Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurities

    Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% due to failed impurities and degradation specifications.

    Product
    Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1815-2019·2019-06-26

    Arrow JACC Medical Device Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 3 units of Arrow JACC with Chloragard Technology due to an incorrect expiration date.

    Product
    Arrow¿ JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1456-2019·2019-06-19

    Laird Superfood Performance Mushrooms Recalled for Iron Labeling Error

    Laird Superfood is recalling Performance Mushrooms because the label incorrectly lists 14 mg of Iron instead of the actual 14 mcg.

    Product
    Performance Mushrooms product is dried mushroom blend of 4 different mushroom mycelial biomass powders cultured on certified organic oats, brand Laird Superfood, uses as Beverage Booster and Functional Fuel Supplement. Product is packaged in 3.17 oz (90 gram) stand up with…
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1396-2019·2019-06-19

    Bausch & Lomb Recalls Lotemax Ophthalmic Gel for Viscosity Issues

    Bausch & Lomb is recalling Lotemax ophthalmic gel because it failed stability specifications for viscosity. The recall covers 17,083 bottles distributed nationwide.

    Product
    LOTEMAX — LOTEMAX (LOTEPREDNOL ETABONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1699-2019·2019-06-12

    Fresenius 2008T BlueStar Hemodialysis Machines Recalled for Power Logic Board Fail Message

    Fresenius Medical Care is recalling 257 units of the 2008T BlueStar hemodialysis machine due to a power logic board fail message on software version 2.72.

    Product
    2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1389-2019·2019-05-29

    Collagen Matrix Recalls Neomem Membrane Due to Incorrect Packaging

    Collagen Matrix, Inc. is recalling Neomem Resorbable Collagen Membranes because they were packaged in the wrong box, potentially inside a Neomem FLEXPLUS box.

    Product
    Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1362-2019·2019-05-22

    Abbott Multichem S Plus Quality Control Serum Recalled for Missing Dry Ice

    Abbott Laboratories is recalling Technopath Multichem S Plus Level 1 quality control serum because units were delivered without required dry ice.

    Product
    Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1356-2019·2019-05-22

    Abbott Recalls ARCHITECT HbA1C Calibrators Shipped Without Dry Ice

    Abbott Laboratories is recalling ARCHITECT HbA1C Calibrators in Latvia because they were delivered without the required dry ice.

    Product
    ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1360-2019·2019-05-22

    Abbott Troponin-I Calibrators Recalled for Missing Dry Ice Packaging

    Abbott Laboratories is recalling ARCHITECT STAT High Sensitive Troponin-I Calibrators because they were delivered without the required dry ice.

    Product
    ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1359-2019·2019-05-22

    Abbott Troponin-I Controls Recalled for Missing Dry Ice

    Abbott Laboratories is recalling ARCHITECT STAT High Sensitive Troponin-I Controls delivered without required dry ice to Latvia.

    Product
    ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1358-2019·2019-05-22

    Abbott Recalls ARCHITECT Intact PTH Calibrators Due to Missing Dry Ice

    Abbott Laboratories is recalling two units of ARCHITECT Intact PTH Calibrators because they were delivered without the required dry ice.

    Product
    ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1363-2019·2019-05-22

    Abbott Technopath Multichem S Plus Level 2 Recalled for Missing Dry Ice

    Abbott Laboratories is recalling Technopath Multichem S Plus Level 2 quality control serum delivered to Latvia without required dry ice.

    Product
    Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1361-2019·2019-05-22

    Abbott Recalls Alinity i Anti-TPO Calibrators Due to Missing Dry Ice

    Abbott Laboratories is recalling Alinity i Anti-TPO Calibrators in Latvia because they were delivered without required dry ice.

    Product
    ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1355-2019·2019-05-22

    Abbott Recalls ARCHITECT Sirolimus Calibrators Shipped Without Dry Ice

    Abbott Laboratories is recalling ARCHITECT Sirolimus Calibrators in Latvia because they were delivered without the required dry ice.

    Product
    ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1357-2019·2019-05-22

    Abbott Recalls ARCHITECT Intact PTH Controls Due to Missing Dry Ice

    Abbott Laboratories is recalling ARCHITECT Intact PTH Controls because they were delivered without required dry ice. The recall affects units distributed to Latvia.

    Product
    ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1256-2019·2019-05-08

    Lin-Zhi International Recalls Ethyl Alcohol Enzymatic Assay Kits

    Lin-Zhi International Inc is recalling 49 Ethyl Alcohol Enzymatic Assay kits due to potential detergent contamination that may reduce shelf life.

    Product
    Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1280-2019·2019-05-08

    Dermoplast Anesthetic Spray Recalled for Incorrect Net Weight Labeling

    Advantice Health is recalling Dermoplast Anesthetic Spray canisters because some full cases contain cans labeled with an incorrect net weight of 2.75 oz instead of 2.0 oz.

    Product
    Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only; Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; Product Code 80-6802; Case UPC 1 03 16864 68002 7.
    Category
    Drug
    Distribution
    Distributed nationwide