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.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

31226–31250 of 40325

  • ModerateFDA (Devices)·Z-0600-2016·2016-01-13

    KCI ActiV.A.C. Canisters Recalled for Potential Pinhole Leaks

    KCI USA is recalling ActiV.A.C. 300ml Canisters distributed in Japan and Australia due to potential pinhole leaks in the pouches.

    Product
    ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0614-2016·2016-01-13

    Siemens Acute Care CCRP TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc is recalling 78 units of the Acute Care CCRP TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer Catalog Number: CCCRP SMN:10445066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0583-2016·2016-01-13

    Ultradent Recalls InterGuard Dental Refills Due to Manufacturing Defect

    Ultradent is recalling InterGuard 5.5mm Econo Refills because the floss tether hole was not completely punched through.

    Product
    InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0599-2016·2016-01-13

    NIPRO SafeTouch II Safety AVF Needle Recall for Torn Wings

    Nipro Medical Corporation is recalling 160,000 NIPRO SafeTouch II Safety AVF Needles because the device has the potential to have torn wings.

    Product
    NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0557-2016·2016-01-06

    Elekta Recalls MOSAIQ Oncology System Due to Dosage Calculation Error

    Elekta, Inc. is recalling 399 units of the MOSAIQ Oncology Information System because a software issue with age and weight data can cause incorrect drug dosages.

    Product
    MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0561-2016·2016-01-06

    Beckman Coulter MicroScan Pos Breakpoint Combo Panel Recall

    Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panel Type 20 due to falsely negative Voges-Proskauer results.

    Product
    MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0569-2016·2016-01-06

    BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive

    Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because they may contain insufficient EDTA additive, which can lead to erroneous platelet results.

    Product
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0568-2016·2016-01-06

    BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive

    Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because some were manufactured with insufficient EDTA additive, which may lead to erroneous platelet results.

    Product
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0566-2016·2016-01-06

    Aesculap Valve XS Atrium Retractor Blades Recalled Due to Corrosion

    Aesculap is recalling 41 Valve XS Atrium Retractor blades distributed in New York because corrosion was found on a ball joint caused by incorrect manufacturing materials.

    Product
    Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0570-2016·2016-01-06

    BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive

    Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because some were manufactured with insufficient EDTA additive, which may lead to erroneous platelet results.

    Product
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0559-2016·2016-01-06

    Beckman Coulter MicroScan Pos Combo Panel Recall for False Negative Results

    Beckman Coulter is recalling MicroScan Pos Combo panels that may produce falsely negative Voges-Proskauer results for Staphylococcus aureus.

    Product
    MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0563-2016·2016-01-06

    Trumpf Ceiling Mounted Surgical Light Systems Recalled for Falling Hazard

    Trumpf Medical Systems is recalling 20,713 ceiling-mounted surgical light systems because the spring arm can detach, causing the light head to fall.

    Product
    Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0567-2016·2016-01-06

    BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive

    Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA blood collection tubes because some were manufactured with insufficient EDTA additive, which may lead to erroneous platelet results.

    Product
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA The Vacutainer Brand PLUS (Plastic) Tube with EDTA Vacutainer¿ Brand Serum Tube are evacuated blood collection tubes which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0560-2016·2016-01-06

    Beckman Coulter MicroScan Pos Combo Panels Recalled for False Negative Results

    Beckman Coulter is recalling MicroScan Pos Combo and Breakpoint Combo panels due to falsely negative Voges-Proskauer results with Staphylococcus aureus.

    Product
    MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0558-2016·2016-01-06

    Beckman Coulter MicroScan Pos Combo Panel Recall for False Negatives

    Beckman Coulter is recalling MicroScan Pos Combo panels due to falsely negative Voges-Proskauer results with Staphylococcus aureus.

    Product
    MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0571-2016·2016-01-06

    BD Vacutainer K2EDTA Tubes Recalled for Insufficient Additive

    Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because some were manufactured with insufficient EDTA additive, which may lead to erroneous platelet results.

    Product
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0562-2016·2016-01-06

    Beckman Coulter Recalls MicroScan Pos Breakpoint Combo Panels Due to False Negatives

    Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panels because they may produce falsely negative results for Staphylococcus aureus quality control tests.

    Product
    MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0556-2016·2016-01-06

    Biomerieux Recalls Granada Biphasic Broth Due to Missing FDA Clearance

    Biomerieux Inc is recalling 24 cartons of Granada Biphasic Broth because the product lacks required FDA 510(k) clearance for marketing in the United States.

    Product
    Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0564-2016·2016-01-06

    Biomet 3i Recalls Radiographic Transparencies Due to Undersized Images

    Biomet 3i is recalling 686 radiographic transparencies because the images are undersized, which may affect dental implant measurements.

    Product
    Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0555-2016·2016-01-06

    Merge Healthcare Recalls Unvalidated Cardio and HEMO Software Versions

    Merge Healthcare is recalling Merge HEMO V10.0 and Merge CARDIO V10.1 software distributed to three customers before complete in-house validation.

    Product
    Merge Cardio with software version 10.1 LA.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0554-2016·2016-01-06

    Merge Hemo Software Recalled Due to Incomplete Validation

    Merge Healthcare is recalling Merge Hemo software version 10.0 LA because it was distributed to three customers before being fully validated in-house.

    Product
    Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0565-2016·2016-01-06

    RenovoCath RC 120 Catheter Recalled for Incorrect Instructions for Use

    RenovoRx, Inc. is recalling 11 units of the RenovoCath RC 120 Temporary Intravascular Occluding Catheter because incorrect Instructions for Use were shipped to customers.

    Product
    RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to…
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-0442-2016·2015-12-30

    Biomerieux Etest PIP/TAZO/CON-4 PTC 256 Recalled for Erroneous Results

    Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC 256 antimicrobial susceptibility tests due to the potential for reporting false susceptible results for Piperacillin/Tazobactam.

    Product
    Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0448-2016·2015-12-30

    Aesculap Flexible Orthopedic Instrument Tray Set Recalled for Breakage Risk

    Aesculap, Inc. is recalling flexible orthopedic instrument tray sets because the shafts may break during surgery, potentially leaving fragments in patients.

    Product
    Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0392-2016·2015-12-30

    Boston Scientific Recalls Chariot Guiding Sheaths Due to Shaft Separation

    Boston Scientific is voluntarily recalling Chariot Guiding Sheaths after receiving complaints about shaft separation, which could lead to embolism of device fragments.

    Product
    Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 45 cm, ST, CC H74939277545110 Guiding Sheath 5F, 45 cm, MP, CC H74939277545210 Guiding Sheath 6F, 45 cm, ST, CC H74939277645110…
    Category
    Medical Device
    Distribution
    Distributed nationwide