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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24376–24400 of 27699

  • SevereFDA (Devices)·Z-0018-2015·2014-10-15

    Cardinal Health Prefilled Buffered 10% Formalin Recalled for Concentration Issues

    Richard-Allan Scientific Company is recalling Cardinal Health Prefilled Buffered 10% Formalin because the formalin concentration may be outside specifications.

    Product
    Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0012-2015·2014-10-15

    Richard-Allan Scientific Recalls Protocol 10% NBF Tissue Fixative

    Richard-Allan Scientific is recalling 175 cases of Protocol 10% NBF tissue fixative because the concentration may be outside specifications.

    Product
    Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0058-2015·2014-10-15

    Biomet Recalls Mamba Disposable Nitinol Needles Due to Breakage Risk

    Biomet is recalling 164 Mamba Disposable Nitinol Needles because high friction may cause the needles to break during use.

    Product
    Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0014-2015·2014-10-15

    Richard-Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Concentration Issues

    Richard-Allan Scientific is recalling 10% Neutral Buffered Formalin because the concentration may be outside specifications. The product is used to fixate tissue for histological examination.

    Product
    Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0052-2015·2014-10-15

    Zoll Pro-padz Sterile Electrodes Recalled Due to Sterility Concerns

    Bio-Detek is recalling 237 cases of Zoll Pro-padz Sterile Multi-Function Electrodes because product sterility is not assured. The affected lots were distributed worldwide.

    Product
    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0042-2015·2014-10-15

    McKesson Cardiology Hemo Software Recall for Hemoglobin Calculation Error

    McKesson Information Solutions LLC is recalling 272 McKesson Cardiology Hemo devices because a software error incorrectly converts hemoglobin values used in formula calculations.

    Product
    McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0038-2015·2014-10-15

    DePuy Orthopaedics Recalls RECLAIM Distal Reamer Extension Devices

    DePuy Orthopaedics is recalling 875 units of RECLAIM Distal Reamer Extension devices because the tabs may break and leave fragments in the patient.

    Product
    RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0036-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0224751, REF/Catalog No. 60M022475, STERILE --- Indicated for short or long-term peripheral access to the central venous system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0032-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits with Compromised Sterility

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0057-2015·2014-10-15

    Biomet Recalls Green Mamba Suture Passers Due to Needle Breakage Risk

    Biomet, Inc. is recalling 12 units of Green Mamba Suture Passers because high friction may cause the needle to break during use.

    Product
    Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2015·2014-10-15

    Bio-Detek Recalls ZOLL Pro-padz Sterile Adult Electrodes Due to Sterility Concerns

    Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because product sterility is not assured. The recall affects 41 single units distributed worldwide.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0056-2015·2014-10-15

    Biomet Black Mamba Suture Passer Recalled Due to Needle Breakage Risk

    Biomet, Inc. is recalling 15 units of Black Mamba Suture Passers because high friction may cause the needle to break during use.

    Product
    Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0059-2015·2014-10-15

    Sterilmed Recalls Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters

    Sterilmed is recalling 22 reprocessed diagnostic ultrasound catheters because they were incorrectly processed. The affected units were distributed in Washington and California.

    Product
    Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0011-2015·2014-10-15

    Nemschoff Serenity Treatment Chairs Recalled for Potential Elevated Temperatures

    Nemschoff Chairs, Inc. is recalling Serenity Treatment Chairs due to potential elevated temperatures in the seat and back lumbar areas.

    Product
    Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0053-2015·2014-10-15

    ZOLL Pro-padz Sterile Electrodes Recalled Due to Sterility Concerns

    Bio-Detek is recalling ZOLL Pro-padz Sterile Multi-Function Electrodes because product sterility is not assured. The recall affects lots 1614 and 1814 distributed worldwide.

    Product
    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0029-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M2309831, REF/Catalog No. 60M230983, STERILE --- Indicated for short or long-term peripheral access to the central venous system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0034-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling 51 PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Product No. H96560M0367061, REF/Catalog No. 60M036706, STERILE --- Indicated short or long-term peripheral access to the central venous system for intravenous therapy, including but not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2015·2014-10-15

    Biomedix SELEC-3 I.V. Administration Set Recalled Due to Adhesive Failure

    Biomedix is recalling SELEC-3 I.V. Administration Sets because insufficient glue application caused the sets to fail.

    Product
    Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0028-2015·2014-10-15

    Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Defects

    Navilyst Medical is recalling BioFlo PICC Kits because they contain BD syringes with open seals that may compromise sterility.

    Product
    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0054-2015·2014-10-15

    ZOLL Pro-padz Sterile Adult Electrodes Recalled Due to Sterility Concerns

    Bio-Detek is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because product sterility is not assured. The recall affects 193 cases distributed worldwide.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2015·2014-10-15

    ArjoHuntleigh Contoura C1000 and C1080 Bariatric Beds Recalled for Entrapment Risk

    Arjo Hospital Equipment AB is recalling 1,695 Contoura C1000 and C1080 bariatric beds worldwide due to a low but existing risk of patient entrapment for individuals with a BMI under 40.

    Product
    ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0061-2015·2014-10-15

    DePuy Charnley Pin Retractor and Handle Set Recalled for Component Breakage

    DePuy Orthopaedics is recalling 65 units of the Charnley Pin Retractor and Handle Set because the small extraction peg is breaking from the pin.

    Product
    Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open…
    Category
    Medical Device
    Distribution
    Distributed nationwide