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.

9276–9300 of 21595

  • ModerateFDA (Devices)·Z-1062-2019·2019-04-03

    Keystone Dental Recalls Paltop Surgical Kits Due to Oversized Hex Driver

    Keystone Dental Inc. is recalling Paltop Fully Guided Surgical Kits because the included 1.25mm Hex Driver may be oversized, making it difficult to engage screws and abutments.

    Product
    Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1063-2019·2019-04-03

    Keystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue

    Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers because the hex driving feature may be slightly oversized, making it difficult to engage screws and abutments.

    Product
    Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1056-2019·2019-04-03

    Allergan Recalls 72 Bottles of Combigan Eye Drops for cGMP Deviations

    Allergan is voluntarily recalling 72 bottles of Combigan ophthalmic solution in Tennessee due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    COMBIGAN — COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1064-2019·2019-04-03

    Keystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue

    Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers because the oversized feature makes it difficult to engage screws and abutments.

    Product
    Paltop 1.25 Hex Drivers, Short Part Number: 60-70102
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1061-2019·2019-04-03

    Ecolab Recalls Advanced Gel Hand Sanitizer Due to Chemical Contamination

    Ecolab is recalling Advanced Gel Hand Sanitizer because low levels of substituted benzene compounds were found after complaints of malodor.

    Product
    ADVANCED GEL HAND SANITIZER — ADVANCED GEL HAND SANITIZER (ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1064-2019·2019-04-03

    Ecolab Recalls Express Gel Hand Sanitizer Due to Chemical Contamination

    Ecolab is recalling 105 bottles of Express Gel Hand Sanitizer due to low levels of substituted benzene compounds found after malodor complaints.

    Product
    Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1241-2019·2019-04-03

    Kroger Recalls 16 oz Quinoa Packages for Possible Pesticide Contamination

    The Kroger Company is recalling 16 oz packages of quinoa due to possible contamination with pesticide. Consumers should check their pantries for the specific best-by dates listed.

    Product
    Quinoa, 16 oz plastic package
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1061-2019·2019-04-03

    Keystone Dental Recalls Paltop Surgical Kits with Oversized Hex Drivers

    Keystone Dental Inc is recalling 13 Paltop Premium Surgical Kits because the 1.25mm Hex Drivers may be slightly oversized, making it difficult to engage screws and abutments.

    Product
    Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1063-2019·2019-04-03

    Ecolab Recalls Quick-Care Foam Hand Sanitizer Due to Chemical Contamination

    Ecolab is recalling 67 units of Quick-Care Foam Hand Sanitizer due to low levels of substituted benzene compounds found after malodor complaints.

    Product
    Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-491-85
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·040-2019·2019-04-02

    AdvancePierre Recalls Frozen Beef Patties Due to Possible Plastic Contamination

    AdvancePierre Foods is recalling approximately 20,373 pounds of frozen beef patties that may contain soft purple plastic. No illnesses have been reported.

    Product
    AdvancePierre Foods, Inc. — AdvancePierre Foods, Inc. Recalls Frozen Beef Patties due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1016-2019·2019-03-27

    Randox Fructosamine Calibrator Recall Due to Value Reassignment

    Randox Laboratories is recalling 85 kits of Fructosamine Calibrator FR2993 because the assigned value was decreased by 25%.

    Product
    Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1028-2019·2019-03-27

    Smith & Nephew Recalls Mislabelled Hip Stem Implants Due to Size Error

    Smith & Nephew is recalling 58 hip stem implants because the outer label incorrectly identified the product as size "1" instead of "-1".

    Product
    smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1035-2019·2019-03-27

    ConvaTec Recalls Forceps Blue Due to Potential Sterile Barrier Breach

    ConvaTec, Inc. is recalling Forceps Blue, disposable sterile forceps, because an internal assessment confirmed the potential for a breach in the sterile barrier.

    Product
    Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forcep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1029-2019·2019-03-27

    Smith & Nephew Recalls Mislabelled High Offset StikTite Coated Hip Stems

    Smith & Nephew is recalling 9 units of hip stems where the outer label incorrectly identified the product as size "1" instead of the actual size "-1".

    Product
    smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1032-2019·2019-03-27

    ACell Recalls Gentrix Surgical Matrix Thick Due to Tensile Strength Failure

    ACell, Inc. is recalling one lot of Gentrix Surgical Matrix Thick devices because a sample failed to meet tensile strength specifications.

    Product
    Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1181-2019·2019-03-27

    Lamb's Supreme Starz Potato Product Recalled for Foreign Material Contamination

    Lamb Weston is recalling Lamb's Supreme Starz star-shaped potato products due to contamination with foreign material. The recall affects specific lots distributed in the US and several international markets.

    Product
    Lamb's Supreme Starz, item S0026, is formed star-shaped potato product that has been par-fried and frozen. Product is packaged in a five-pound, food service, clear poly bag; the bags are boxed six bags per case (30 lbs net weight). Bags are placed in a corrugated cardboard case
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1017-2019·2019-03-27

    Randox Fructosamine Calibrator Recall Due to Value Reassignment

    Randox Laboratories is recalling 141 kits of Fructosamine Control 1 because the assigned value was decreased by 25%.

    Product
    Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1011-2019·2019-03-27

    Akorn Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Low Potency

    Akorn Inc is recalling Hydrocortisone and Acetic Acid Otic Solution because routine stability testing revealed the drug was sub-potent.

    Product
    Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1038-2019·2019-03-27

    ConvaTec Recalls FilterFlow Suction Handles Due to Sterile Barrier Breach Risk

    ConvaTec is recalling 124,000 FilterFlow Suction Handles because an internal assessment found a potential breach in the sterile barrier.

    Product
    FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1018-2019·2019-03-27

    Randox Fructosamine Control 3 Calibrator Recall Due to Value Reassignment

    Randox Laboratories is recalling 133 kits of Fructosamine Control 3 because the assigned value was decreased by 25%. The product is used for in vitro calibration.

    Product
    Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1033-2019·2019-03-27

    ACell Recalls Gentrix Surgical Matrix Thick Due to Tensile Strength Failure

    ACell, Inc. is recalling one lot of Gentrix Surgical Matrix Thick because a sample failed to meet tensile strength specifications.

    Product
    Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1014-2019·2019-03-27

    Siemens Dimension Vista 500 Analyzer Recall for Water Module Contamination

    Siemens is recalling 5,373 Dimension Vista 500 analyzers because specific Millipore water purification modules may cause falsely elevated triglyceride results.

    Product
    Dimension Vista 500, Analyzer, chemistry Model no. 10284473
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1015-2019·2019-03-27

    Siemens Dimension Vista 1500 Analyzer Recall Due to Water Module Contamination

    Siemens is recalling 5,373 Dimension Vista 1500 analyzers because specific water purification modules may cause falsely elevated triglyceride results.

    Product
    Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1007-2019·2019-03-27

    Docusate Sodium Softgels Recalled Due to Incorrect Secondary Carton Labeling

    Rx Pak Division of McKesson Corporation is recalling Docusate Sodium 100mg softgels because secondary cartons may be mislabeled as Gabapentin 300mg.

    Product
    Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Miami, Fl 33186, NDC 63739-0478-10
    Category
    Drug
    Distribution
    0 states