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.

15876–15900 of 21645

  • ModerateFDA (Devices)·Z-2424-2015·2015-08-26

    International Biophysics Corp. Recalls IBC Vascular Loops Due to Seal Issues

    International Biophysics Corp. is recalling 771 IBC Vascular Loops because heat seals on sterile pouches may not meet strength criteria.

    Product
    IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2015·2015-08-26

    Radiometer Fixation Kit N20 Recalled for Paper Coating Transfer

    Radiometer America Inc is recalling Fixation Kit N20 units because paper liner coating may stick to the fixation ring.

    Product
    Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are used with the TCM CombiM monitoring system and the Philips TcG10 module. The…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1346-2015·2015-08-26

    Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigations

    Wockhardt USA is recalling 1,704 bottles of Lisinopril 5 mg tablets because an FDA inspection found inadequate investigations of past market complaints.

    Product
    Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2416-2015·2015-08-26

    Siemens ADVIA Chemistry Acetaminophen Reagents Recalled for NAC Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Acetaminophen reagents due to a change in N-acetylcysteine concentration that may cause assay interference.

    Product
    ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2969-2015·2015-08-26

    HEB Seeded Hamburger Buns Recalled for Potential Cotton Fiber Contamination

    H E B Grocery Company is recalling specific lots of HEB Bake Shop seeded hamburger buns because they may contain cotton fibers.

    Product
    HEB Bake Shop 8 Seeded Hamburger Buns Enriched Buns, Net Wt. 18 OZ (1 LB 2 OZ), UPC: 041220101276; HEB Bake Shop 6 Texas Sized Seeded Hamburger Buns Enriched Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 041220217618
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1348-2015·2015-08-26

    UCB Recalls Univasc Tablets Due to Failed Dissolution Testing

    UCB, Inc. is recalling Univasc (moexipril HCl) tablets because they failed 24-month dissolution testing. The recall covers 2,916 bottles distributed nationwide.

    Product
    univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2427-2015·2015-08-26

    Stryker Recalls uHead and Other Ulnar Implants Due to Packaging Concerns

    Stryker is recalling specific ulnar implants because the sterile packaging may be compromised by transportation.

    Product
    uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2430-2015·2015-08-26

    Stryker Recalls Sigmoid Notch Radial Plates Due to Packaging Integrity Concerns

    Stryker is recalling Sigmoid Notch Radial Plates because the sterile packaging barrier may be compromised during transportation.

    Product
    Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2425-2015·2015-08-26

    Synthes Medical Nail Wraps Recalled for Insufficient Multi-Use Testing

    Synthes (USA) Products LLC is recalling specific tibial and intramedullary nail wraps because they lack sufficient testing to be considered multi-use items.

    Product
    Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Universal Tibial Nails, Unreamed Tibial Nail, and the Stainless Steel Tibial Nail…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2426-2015·2015-08-26

    Stryker Recalls rHead and uHead Implants Due to Packaging Integrity Concerns

    Stryker Howmedica Osteonics Corp. is recalling specific rHead, uHead, and other radial implants because their sterile packaging may be compromised by transportation.

    Product
    rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2972-2015·2015-08-26

    Hill Country Fare Hot Dog Buns Recalled for Cotton Fibers

    H E B Grocery Company is recalling Hill Country Fare and HEB Bake Shop hot dog buns because they may contain cotton fibers.

    Product
    Hill Country Fare 16 Hot Dog Buns Enriched Buns, Net Wt. 24 OZ (1 LB 8 OZ) (680g). UPC: 04122041611; Hill Country Fare 8 Hot Dog Buns Enriched Buns, Net Wt. 12 OZ (340g), UPC: 041220602018; HEB Bake Shop 8 White Hot Dog Buns Enriched Buns, Net Wt. 12 OZ, UPC: 041220839100
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2387-2015·2015-08-26

    C.R. Bard Recalls Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters

    C.R. Bard is recalling specific lots of Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2386-2015·2015-08-26

    C.R. Bard Recalls Magic3 Female Intermittent Urinary Catheters

    C.R. Bard is recalling 37,686 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·113-2015·2015-08-25

    Kraft Heinz Recalls Turkey Bacon Products Due To Possible Adulteration

    Kraft Heinz is recalling approximately 2.1 million pounds of Oscar Mayer turkey bacon products that may spoil before their expiration dates.

    Product
    Kraft Heinz Foods Company — Kraft Heinz Foods Company Recalls Turkey Bacon Products Due To Possible Adulteration
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2364-2015·2015-08-19

    Cadence Recalls Perfectum Tuberculin Glass Syringes Due to Misaligned Marks

    Cadence Inc. is recalling 766 non-sterile Perfectum Tuberculin Glass Syringes because graduation marks are not centered with numeric position marks.

    Product
    Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2945-2015·2015-08-19

    Lee Egg Rolls Recalled for Undeclared Monosodium Glutamate

    LV Foods is recalling Lee Egg Rolls Vegetables and Textured Vegetable Protein due to undeclared monosodium glutamate (MSG). The product was distributed in California.

    Product
    Lee Egg Rolls Vegetables and Textured Vegetable Protein, Net Wt. 15lbs. 0 oz., Lee Egg Rolls Jacinto City, Texas 77029
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2947-2015·2015-08-19

    Mitsuwa Recalls Baked Seasoned Sardine and Goby Products for Temperature Violation

    Mitsuwa Corporation is recalling three baked fish products because they were not kept refrigerated as required by their labels.

    Product
    Baked Seasoned Sardine Okabe (Asuri Washi Shiokoki) Net Wt.: 70GR/2.47oz SKU: 4 971455 081714 Ingredients: Sardine, Salted Rice Malt, Sugar, Sorbitol, Monosodium Glutamate Keep Refrigerated Exported By: KC Central Trading Co. Ltd. 4F 7-2 Irifune 3-Chome Chuo-Ku…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2379-2015·2015-08-19

    Boston Scientific Recalls AngioJet Thrombectomy Sets Due to Incorrect Expiry Date

    Boston Scientific is recalling 9 AngioJet SOLENT Dista Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.

    Product
    AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-2948-2015·2015-08-19

    Mitsuwa Recalls Baked Sardine and Goby Products for Temperature Violations

    Mitsuwa Corporation is recalling three baked fish products because they were not kept refrigerated as required by their labels.

    Product
    Baked Seasoned Sardine Ambient Okabe (Iwashi Senbei) Net Wt.: 77GR/2.65oz Ingredients: Sardines, Sugar, Milk Protein Hydrolysate, Soy Sauce (Water, Soybean, Wheat, Salt), Sweet Cooking Wine, Sesame, Red Pepper, Monosodium Glutamate Keep Refrigerated Product of Japan…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2377-2015·2015-08-19

    Boston Scientific Recalls AngioJet Spiroflex Thrombectomy Sets Due to Incorrect Expiry Date

    Boston Scientific is recalling nine AngioJet Spiroflex Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.

    Product
    AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1321-2015·2015-08-19

    Sensodyne Toothpaste Recalled for Wood Fragments

    GlaxoSmithKline is recalling Sensodyne Complete Protection toothpaste because wood fragments were found in the product.

    Product
    SENSODYNE COMPLETE PROTECTION — SENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2953-2015·2015-08-19

    Chemi-source Recalls DHEA 25mg Capsules for Labeling Inaccuracy

    Chemi-source, Inc. is recalling DHEA 25mg capsules because they may contain more DHEA than the label claims.

    Product
    DHEA 25mg, 60 count, sku: #6-09492-41001-6, and 90 count, sku: #6-09492-41002-3; 12 bottles/case.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2351-2015·2015-08-19

    Remel Recalls PathoDx Strep B Grouping Latex Reagent

    Remel Inc is recalling PathoDx Strep B Grouping Latex because a reagent may cause weak reactions, potentially leading to failure to identify target species.

    Product
    PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2375-2015·2015-08-19

    Advanced Sterilization Products Recalls STERRAD 100NX Wall Charts for Incorrect Instructions

    Advanced Sterilization Products is recalling 1,465 STERRAD 100NX wall charts because they contain incorrect instructions regarding instrument tray wrapping.

    Product
    Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide