The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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Any3+ (High and above)4+ (High and above)5+ (High and above)

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36526–36550 of 40449

  • ModerateFDA (Devices)·Z-0906-2014·2014-02-12

    Exactech Recalls InteGrip Acetabular Augments Due to Biological Evaluation Failure

    Exactech is recalling 235 units of InteGrip Acetabular Augments because an in-vitro biological evaluation standard was out of range.

    Product
    ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0904-2014·2014-02-12

    Horiba Medical Recalls ABX PENTRA N Control for Revised Potassium Values

    Horiba Medical is recalling ABX PENTRA N Control units because the product was updated to include a revised Target Value assignment for Potassium.

    Product
    ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0934-2014·2014-02-12

    OrthoPediatrics Recalls 3.5mm Locking Cortical Bone Screws Due to Packaging Error

    OrthoPediatrics is recalling 12 units of 3.5mm Locking Cortical Bone Screws because the packages incorrectly contain non-locking screws.

    Product
    3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0922-2014·2014-02-12

    Highland Metals Recalls SuperElastic NiTi Archwires Due to Labeling Errors

    Highland Metals, Inc. is recalling SuperElastic NiTi archwires because some packages labeled 'Upper' contain 'Lower' archwires and vice versa.

    Product
    SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0923-2014·2014-02-12

    Highland Metals Recalls SuperElastic NiTi Orthodontic Archwires Due to Labeling Errors

    Highland Metals, Inc. is recalling SuperElastic NiTi orthodontic archwires because some packages are mislabeled, potentially containing the wrong arch type.

    Product
    SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0909-2014·2014-02-12

    Nipro Diagnostics Recalls Blood Glucose Monitors With Incorrect Factory Settings

    Nipro Diagnostics is recalling 501 units of the MooreBrand TRUEbalance Blood Glucose Monitor because they were manufactured with an incorrect factory set unit of measure.

    Product
    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0910-2014·2014-02-12

    Nipro Diagnostics Recalls TRUEtrack Blood Glucose Monitors Due to Unit Error

    Nipro Diagnostics is recalling 105 TRUEtrack blood glucose monitors because they were manufactured with an incorrect factory set unit of measure.

    Product
    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0924-2014·2014-02-12

    Horiba Medical Recalls ABX PENTRA Urine Control L/H for Creatinine Range Update

    Horiba Medical is recalling ABX PENTRA Urine Control L/H because the target range for the Creatinine assay was updated. The recall affects 531 units distributed in the US and Canada.

    Product
    ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0838-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 2 units of the Aquarius Hot/Cold Therapy Combo Unit due to temperature monitoring failures and electric shock reports.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0834-2014·2014-02-05

    DeRoyal Aquarius Temperature Therapy Units Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 738 Aquarius Temperature Therapy units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0859-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 895 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0836-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 409 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0839-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 25 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0837-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature and Shock Risks

    DeRoyal Industries is recalling 48 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature and have caused electric shocks.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0862-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 369 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0860-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 431 Codman Certas Programmable Valves because they may not operate properly. These implantable devices are used to manage hydrocephalus.

    Product
    Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0835-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 121 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2014·2014-02-05

    Synergetics Recalls 25ga Endo Illuminator Due to Faulty Seals

    Synergetics Inc is recalling 96 units of 25ga Endo Illuminator devices because faulty seals on the outer pouch could fail, potentially compromising sterility.

    Product
    25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0899-2014·2014-02-05

    Synergetics Recalls 25ga Aspirating Endo Illuminator Due to Seal Failure

    Synergetics is recalling 25ga Aspirating Endo Illuminators because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.

    Product
    25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0877-2014·2014-02-05

    Synergetics Recalls 25ga Awh Chandelier Due to Faulty Sterile Seals

    Synergetics Inc. is recalling 36 units of 25ga Awh Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.

    Product
    25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2014·2014-02-05

    Synergetics Recalls Stiff 25ga Endo Illuminator Due to Faulty Seals

    Synergetics Inc is recalling 48 units of Stiff 25ga Endo Illuminators because faulty seals on the outer pouch could result in seal failure.

    Product
    Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2014·2014-02-05

    Synergetics Recalls Corona Shielded Wide Field Endo Illuminator Due to Seal Failure

    Synergetics Inc. is recalling specific lots of Corona Shielded Wide Field Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    "The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft, sterile / EO, 56.12. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2014·2014-02-05

    Synergetics Recalls 29ga Ophthalmic Chandeliers Due to Faulty Seals

    Synergetics Inc. is recalling 233 units of 29ga Oshima Dual Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the devices.

    Product
    29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide