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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31301–31325 of 40449

  • ModerateFDA (Devices)·Z-0616-2016·2016-01-13

    Siemens Acute Care CCRP CalPak Recall for Barcode Scanning Issues

    Siemens is recalling 65 units of Acute Care CCRP CalPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog Number: CCCRP-C SMN:10445067
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0606-2016·2016-01-13

    Baxter INTERLINK Y-Type Solution Set Recalled for Particulate Matter

    Baxter Healthcare is recalling INTERLINK Y-Type Solution Sets due to potential dark particulate matter on the spike adapter.

    Product
    Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device. .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0615-2016·2016-01-13

    Siemens Acute Care BHCG TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics is recalling 590 units of Acute Care BHCG TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0617-2016·2016-01-13

    Siemens Acute Care BHCG CalPak Recalled Due to Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc. is recalling 196 units of the Acute Care BHCG CalPak because the cartridge barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0609-2016·2016-01-13

    Siemens Acute Care CTNI TestPak Barcode Scanning Recall

    Siemens Healthcare Diagnostics Inc is recalling 5,558 units of the Acute Care CTNI TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0607-2016·2016-01-13

    Baxter CLEARLINK Blood Bag Spike Adapter Recalled for Particulate Matter

    Baxter Healthcare is recalling CLEARLINK Blood Bag Spike Adapters due to potential dark loose particulate matter on the spike.

    Product
    Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0591-2016·2016-01-13

    Biomet 3i Protection Caps Recalled for Inadequate Biocompatibility Testing

    Biomet 3i is recalling specific Protection Caps due to inadequate biocompatibility testing. The devices are distributed worldwide, including the US.

    Product
    BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0618-2016·2016-01-13

    Siemens Acute Care MYO DilPak Recall Due to Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc is recalling 192 units of Acute Care MYO DilPak in vitro diagnostic products because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0619-2016·2016-01-13

    Siemens Acute Care CKMB DilPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc. is recalling 146 units of the Acute Care CKMB DilPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: CCKMB-D SMN: 10445070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0581-2016·2016-01-13

    Natus Quantum System Recalled for Reversed Signal Polarity Display

    Natus Medical is recalling 56 Quantum Systems with NeuroWorks 8.1 software because incoming signals display with reversed polarity.

    Product
    Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with…
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0582-2016·2016-01-13

    Vidco MDP 2000 Remote Patient Monitoring Systems Recalled for Freezing

    Vidco, Inc. is recalling 59 MDP 2000 Series Remote Patient Monitoring Systems because they may freeze and fail to reset without a power cycle.

    Product
    Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0585-2016·2016-01-13

    Synthes 13.5mm Medullary Reamer Head Recalled for Dimensional Mismatch

    Synthes (USA) Products LLC is recalling 65 units of 13.5mm Medullary Reamer Heads that are actually 14mm. The devices are distributed nationwide.

    Product
    SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0584-2016·2016-01-13

    Smith & Nephew Recalls Mislabelled Birmingham Hip Resurfacing Modular Heads

    Smith & Nephew is recalling 16 Birmingham Hip Resurfacing Modular Heads in the US because they were incorrectly labeled as a different device type not cleared for US marketing.

    Product
    BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HEAD 38 MM -8MM 74121242, MODULAR HEAD 42 MM -8MM 74121246, MODULAR HEAD 46 MM -8MM 74121250, MODULAR HEAD 50 MM -8MM 74121254, MODULAR HEAD 54 MM -8MM 74121258, MODULAR HEAD 58 MM -8MM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0610-2016·2016-01-13

    Siemens Acute Care pBNP TestPak Recalled Due to Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc is recalling 1,157 Acute Care pBNP TestPaks because their barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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