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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31701–31725 of 40449

  • HighFDA (Devices)·Z-0186-2016·2015-11-04

    FDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 77 custom cardiovascular surgical kits because a component's compromised packaging may affect sterility assurance.

    Product
    Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0190-2016·2015-11-04

    Resource Optimization Recalls 28 Custom Cardiovascular Surgical Kits

    Resource Optimization & Innovation LLC is recalling 28 custom cardiovascular surgical kits because a component had compromised package integrity, potentially affecting sterility.

    Product
    Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0118-2016·2015-11-04

    Siemens CIOS ALPHA Fluoroscopic X-Ray System Recalled for Potential Failure

    Siemens Medical Solutions is recalling 44 CIOS ALPHA fluoroscopic x-ray systems due to a potential system failure that could interrupt patient procedures.

    Product
    CIOS ALPHA; image intensified fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2016·2015-11-04

    Siemens ADVIA Chemistry XPT Systems Recalled for Unflagged Electrode Errors

    Siemens is recalling ADVIA Chemistry XPT systems because unplugged electrodes may cause unflagged errors in sodium, potassium, or chloride results.

    Product
    ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0177-2016·2015-11-04

    Philips Recalls Brilliance Big Bore CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 268 Brilliance Big Bore CT systems worldwide due to X-ray measurement errors causing image artifacts.

    Product
    Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2016·2015-11-04

    LifeHealth Recalls BG Cartridges for IRMA TRUPOINT Blood Gas Analyzer

    LifeHealth is recalling BG cartridges for the IRMA TRUPOINT Blood Gas Analyzer because the pH sensor may provide falsely elevated results as the product ages.

    Product
    BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2016·2015-11-04

    LifeHealth Recalls IRMA TRUPOINT Blood Gas Analyzer CC Cartridges

    LifeHealth, LLC is recalling IRMA TRUPOINT Blood Gas Analyzer CC Cartridges because the pH sensor may provide falsely elevated results as shelf life progresses.

    Product
    CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0162-2016·2015-11-04

    Materialise Recalls Patient-Specific Knee Surgical Guides Due to Alignment Inaccuracies

    Materialise N.V. is recalling four patient-specific surgical guides for knee arthroplasty because image data processing errors led to inaccurate surgical planning.

    Product
    Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0185-2016·2015-11-04

    FDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 80 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.

    Product
    Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0187-2016·2015-11-04

    FDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 153 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.

    Product
    Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0166-2016·2015-11-04

    Perkin Elmer Specimen Gate Software Recall for Incorrect Result Interpretation

    Perkin Elmer is recalling Specimen Gate software because abnormal newborn screening test results may be incorrectly interpreted as normal.

    Product
    Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0193-2016·2015-11-04

    Integra Bone Marrow Biopsy Trays Recalled Due to Lidocaine Particulate

    Integra is recalling Bone Marrow Biopsy Trays because they contain Hospira Lidocaine vials with visible particulate matter.

    Product
    Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0179-2016·2015-11-04

    Encore Medical Recalls Turon Shoulder Impaction Fixtures Due to Material Wear

    Encore Medical is recalling 277 Turon Shoulder Impaction Fixtures because polymer material wore off during assembly, potentially contaminating the implant.

    Product
    Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2016·2015-11-04

    FDA Recalls Custom Surgical Kits Due to Compromised Sterility Assurance

    Resource Optimization & Innovation LLC is recalling 17 custom surgical kits in Texas and Louisiana because a component was recalled for compromised package integrity, potentially affecting sterility.

    Product
    Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0163-2016·2015-11-04

    Abbott Recalls ARCHITECT i2000SR Systems Due to Incorrect Tubing

    Abbott Laboratories is recalling 65 ARCHITECT i2000SR diagnostic systems worldwide because they contain incorrect tubing.

    Product
    ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2016·2015-11-04

    Encore Medical Recalls Reverse Shoulder Prosthesis Stem Impaction Fixtures

    Encore Medical is recalling 634 units of Reverse Shoulder Prosthesis Stem Impaction Fixtures because polymer wear from the fixtures can damage the titanium coating on humeral stems during assembly.

    Product
    Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0182-2016·2015-11-04

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Hardware Defects

    Siemens is recalling 2,099 ACUSON SC2000 ultrasound systems due to hardware defects involving wheel lock disconnection and system lockups.

    Product
    ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0192-2016·2015-11-04

    Synthes Threaded Plate Holder Recalled for Incorrect Part Number Etching

    Synthes (USA) Products LLC is recalling 25 units of Threaded Plate Holders that are incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.

    Product
    Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0176-2016·2015-11-04

    Philips Ingenuity Core 128 CT Systems Recalled for X-ray Measurement Error

    Philips Medical Systems is recalling 109 Ingenuity Core 128 CT systems due to X-ray measurement errors causing image artifacts.

    Product
    Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0167-2016·2015-11-04

    Synthes 2.7 mm Locking Screws Recalled for Mislabeling as 2.4 mm

    Synthes (USA) Products LLC is recalling 98 units of 2.7 mm locking screws that were mislabeled as 2.4 mm. The units were distributed to Tennessee.

    Product
    2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0164-2016·2015-11-04

    Sentinel Ammonia Reagent Recalled for Inaccurate Results in Heparin Tubes

    Sentinel CH SpA is recalling 765 kits of Sentinel MULTIGENT Ammonia Ultra Reagent because results may be below the linear range for samples collected in heparin tubes.

    Product
    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0174-2016·2015-11-04

    Philips Recalls Brilliance 64 CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 108 Brilliance 64 CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts.

    Product
    Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0175-2016·2015-11-04

    Philips Ingenuity Core CT Systems Recalled for X-ray Measurement Error

    Philips is recalling 36 Ingenuity Core CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

    Product
    Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2016·2015-11-04

    Philips Recalls Brilliance 16-Slice CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 323 Brilliance 16-Slice CT systems worldwide due to X-ray measurement errors causing Ring/Dot artifacts.

    Product
    Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide