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.

20076–20100 of 21633

  • ModerateFDA (Devices)·Z-1978-2013·2013-08-21

    Terumo Advanced Perfusion System 1 Recall for Pressure Alarm Issue

    Terumo is recalling 1,657 Advanced Perfusion System 1 units to update manuals and address a false high-pressure alarm that can stop the pump.

    Product
    220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1802-2013·2013-08-21

    Ancient Formulas Recalls Keytabs W.O. Glandulars Due to Niacin Levels

    Ancient Formulas Inc is recalling 51,000 bulk tablets of Keytabs W.O. Glandulars because the product contains higher levels of niacin than claimed on the label.

    Product
    Bulk tablet label: Keytabs W.O. Glandulars (pink)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1935-2013·2013-08-21

    Synthes Recalls 5.0mm Stainless Steel Spinal Rods Due to Process Error

    Synthes USA is recalling 492 units of 5.0mm stainless steel spinal rods because they were produced using a finishing process not identified in the manufacturing specification.

    Product
    5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Rod 390mm 5.0mm Unit Rod 410mm 5.0mm Unit Rod 430mm 5.0mm Unit Rod 450mm pedicle screw spinal system; Intended to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-891-2013·2013-08-21

    Total Resources International Recalls 326-Piece First Aid Kits Due to Stability Failures

    Total Resources International is voluntarily recalling 326-piece first aid kits because the active ingredient Benzalkonium Chloride failed stability testing.

    Product
    (No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET PREPARED,326 Pieces of Name Brand & Quality First Aid Supplies, FIRST AID, Total Resources International, Walnut, CA 91789
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1973-2013·2013-08-21

    Terumo Advanced Perfusion System 1 Recalled for False Pump Service Error

    Terumo is recalling Advanced Perfusion System 1 units because user-induced movement may trigger a false 'Service Pump' error message, potentially causing unnecessary service delays.

    Product
    Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1803-2013·2013-08-21

    Ancient Formulas Recalls KEYTABS Tablets Due to Higher Niacin Levels

    Ancient Formulas Inc is recalling KEYTABS tablets because they contain higher levels of niacin than stated on the label.

    Product
    KEYTABS (Without Iron, Copper or Glandulars), packaged in 180-tablet bottles, a product of The Key Company, St. Louis, MO.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1945-2013·2013-08-21

    Siemens AXIOM Artis zeego x-ray system safety notice issued

    Siemens issued a customer safety notice regarding system information overlays after brake functional checks on the AXIOM Artis zeego x-ray system.

    Product
    Siemens AXIOM Artis zeego x-ray, angiographic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-883-2013·2013-08-21

    West-Ward Recalls Belladonna Alkaloids Tablets Due to Foreign Substance

    West-Ward Pharmaceutical Corp. is recalling Belladonna Alkaloids with Phenobarbital Tablets because black specks of degraded organic material were found on the tablets.

    Product
    Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1804-2013·2013-08-21

    Walong Marketing Recalls Asian Taste Sunflower Seeds for Undeclared Sulfites

    Walong Marketing is recalling Asian Taste Sunflower Seeds because they may contain undeclared sulfites. The recall affects 1,090 cartons distributed in California.

    Product
    Asian Taste Sun Flower Seeds, 40pk/carton, Net Wt: 8-oz. (227g), Item #1641819, UPC 6 919037 022708.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1965-2013·2013-08-21

    Arrow International Recalls Two-Lumen CVC Kits Due to Labeling Error

    Arrow International is recalling 156 Two-Lumen CVC Kits because a portion of the packaging incorrectly identifies the catheter as 3-Lumen.

    Product
    Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1974-2013·2013-08-21

    Terumo Advanced Perfusion System 1 Recalled for False Service Pump Error Messages

    Terumo is recalling 1,657 Advanced Perfusion System 1 units because user-induced motor movement can trigger a false 'Service Pump' error message, potentially misleading operators.

    Product
    Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1969-2013·2013-08-21

    Terumo Advanced Perfusion System 1 Recall for Incomplete Operator Manual

    Terumo is recalling 1,657 Advanced Perfusion System 1 units because the operator manual does not fully describe pump reactions during specific alarm conditions.

    Product
    Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1936-2013·2013-08-21

    Atrium Medical Recalls C-QUR Mesh Due to Packaging Adhesion Issues

    Atrium Medical Corporation is recalling C-QUR Mesh products because the coated mesh can adhere to the inner packaging liner when exposed to high humidity.

    Product
    C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-885-2013·2013-08-21

    Bracco Recalls Gastrografin Due to Potential Foreign Particles

    Bracco Diagnostics is recalling one lot of Gastrografin because it may contain black foreign particles.

    Product
    GASTROGRAFIN — GASTROGRAFIN (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1955-2013·2013-08-21

    Fisherbrand Sterile Swabs Recalled Due to Non-Pathogenic Organisms

    Fisher Scientific is recalling Fisherbrand Sterile Swabs after customer complaints reported non-pathogenic organisms in two lots.

    Product
    Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1941-2013·2013-08-21

    OrthoPediatrics Recalls 2.5mm Drill Bits Due to Packaging Labeling Error

    OrthoPediatrics is voluntarily recalling 68 packaged 2.5mm drill bits because the packaging incorrectly lists the size as 3.2mm.

    Product
    3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1960-2013·2013-08-21

    Biomet 3i Dental Implant Recall Due to Outer Box Mislabeling

    Biomet 3i is recalling 51 dental implants because outer boxes may be mislabeled. The implants themselves are correctly labeled, but the error could prevent proper placement.

    Product
    Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-1796-2013·2013-08-21

    Red Mill Farms Recalls Chocolate Macaroons Due to Undeclared Sugar

    Red Mill Farms is recalling Jennies' Dutch Chocolate Macaroons because the packaging fails to list sugar as an ingredient.

    Product
    individual 2 oz chocolate macaroons packaged in plastic wrapper labeled as " Jennies DUTCH CHOCOLATE MACAROON, 2 oz. Red Mill Farms, Inc., Brooklyn, NY".
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1961-2013·2013-08-21

    Biomet 3i Dental Implant Recall for Potential Outer Box Mislabeling

    Biomet 3i is recalling 33 dental implants because outer boxes may be mislabeled. The inner trays are correctly labeled, but the error could prevent proper implant placement.

    Product
    Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1946-2013·2013-08-21

    Stryker Recalls IsoGel AIR 84 Support Surfaces Due to Air Pump Alarm Issues

    Stryker is recalling 586 IsoGel AIR 84 support surfaces because connected air pumps may flash and alarm due to pressure blockages.

    Product
    IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1939-2013·2013-08-21

    Atrium Medical Recalls C-QUR TacShield Mesh Due to Packaging Adhesion

    Atrium Medical Corporation is recalling C-QUR TacShield Mesh units because the coated mesh can adhere to the inner packaging liner when exposed to high humidity.

    Product
    C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1944-2013·2013-08-21

    GE Healthcare Recalls LOGIQ S8 Ultrasound Systems for Measurement Errors

    GE Healthcare is recalling 755 LOGIQ S8 Ultrasound Systems due to a software issue that may cause incorrect image measurements in Virtual Convex mode.

    Product
    GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1930-2013·2013-08-14

    Radiometer TCM4 Base Units Recalled for Electrical Safety Non-Compliance

    Radiometer America Inc is recalling TCM4 series Base Units and Power Supplies because they do not comply with IEC 60601-1 Sub Clause 15B electrical safety standards.

    Product
    TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1871-2013·2013-08-14

    SpineFrontier Recalls Chameleon FacetFuse Drill Guides Due to Mechanical Interference

    SpineFrontier, Inc. is recalling 13 Chameleon FacetFuse Drill Guides because denting and bending prevented proper surgical use.

    Product
    Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition…
    Category
    Medical Device
    Distribution
    5 states