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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29426–29450 of 40325

  • HighFDA (Devices)·Z-2385-2016·2016-08-17

    Philips Ingenuity CT Software Recall for Performance Issues

    Philips Medical Systems is recalling 205 Ingenuity CT units due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.

    Product
    Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2376-2016·2016-08-17

    Hill-Rom Recalls Volker Series Hospital Beds Due to Side Rail Defect

    Hill-Rom is recalling Volker 2080, 2082, S 280, and S 282 series hospital beds because the side rail latch may fail, causing the rail to lower and the patient to fall.

    Product
    Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2396-2016·2016-08-17

    Stryker Recalls Exeter Rasp Handle Due to Malfunctioning

    Stryker Howmedica Osteonics Corp. is recalling 241 Exeter Rasp Handles because they may malfunction during use.

    Product
    Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2398-2016·2016-08-17

    Zimmer Biomet Recalls Zyston Transform Implant Kits Due to Locking Defect

    Zimmer Biomet Spine is recalling five Zyston Transform Implant Kits because the locking mechanism is not functioning as intended.

    Product
    Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2347-2016·2016-08-17

    Philips MX 16-slice CT Systems Recalled for Software Defects

    Philips is recalling 80 MX 16-slice CT systems due to software bugs that may cause image mix-ups or scan interruptions.

    Product
    MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2363-2016·2016-08-17

    Merge PACS software recall for inconsistent mammography lesion measurements

    Merge Healthcare is recalling specific versions of Merge PACS software because lesion measurements differ between unmagnified and magnified mammography images.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2373-2016·2016-08-17

    Ivoclar Vivadent Recalls OptraPol Dental Polishing Discs Due to Breakage

    Ivoclar Vivadent is recalling OptraPol polishing discs and cups because parts break away during use. The recall covers 86 units distributed in 16 states.

    Product
    OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2353-2016·2016-08-17

    Stryker S3 MedSurg Bed Fowler Control Failure Recall

    Stryker is recalling S3 MedSurg Beds because CPU board failures can cause the backrest electronic controls to stop working.

    Product
    S3 MedSurg Bed, Model 3005. Stryker Medical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2389-2016·2016-08-17

    Synthes 2.4mm Titanium Locking Screws Recalled for Breakage Risk

    Synthes (USA) Products LLC is recalling 41 units of 2.4mm Titanium Locking Screws because they can break between the head and shaft due to a thin wall design.

    Product
    Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices The 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm is…
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2352-2016·2016-08-17

    Ortho VITROS Estradiol Reagent Recall Due to Fulvestrant Cross-Reactivity

    Ortho Clinical Diagnostics is recalling VITROS Estradiol Reagent Packs because the drug Fulvestrant causes falsely high test results in postmenopausal women.

    Product
    VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2390-2016·2016-08-17

    Stryker Triathlon Tibial Alignment Handle Recalled Due to Weld Defect

    Stryker Howmedica Osteonics is recalling 47 units of the Specialty Triathlon Tibial Alignment Handle because the secondary locking mechanism may disassociate during surgery due to a weld defect.

    Product
    Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2391-2016·2016-08-17

    Halyard Health Recalls Coolife Sinergy Radiofrequency Kits Due to Component Mismatch

    Halyard Health is recalling 51 Coolife Sinergy Radiofrequency Kits because the electrode length does not match the cannula length.

    Product
    Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2377-2016·2016-08-17

    Stryker Recalls Triathlon Modular Handle Instruments Due to Fit Issues

    Stryker Howmedica Osteonics is voluntarily recalling Triathlon Modular Handle instruments because press fit specifications were not met, potentially causing disassociation.

    Product
    Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2392-2016·2016-08-17

    Hitachi Scenaria CT System Recalled for Power Supply Failure Risk

    Hitachi Medical Systems America is recalling 33 Scenaria CT systems because centrifugal force may cause the power supply to fail, potentially requiring patients to be rescanned.

    Product
    Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2367-2016·2016-08-17

    Philips Brilliance BigBore CT Systems Recalled for Software Defect

    Philips is recalling eight Brilliance BigBore Oncology CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-2382-2016·2016-08-17

    Philips Brilliance iCT SP CT Scanner Software Recall

    Philips is recalling 57 Brilliance iCT SP CT scanners due to software issues in versions 4.1.3 and 4.1.5 that could affect equipment performance.

    Product
    Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2383-2016·2016-08-17

    Philips CT Scanner Software Recall for Performance Issues

    Philips is recalling Ingenuity Core CT scanners due to software issues in versions v4.1.3, v4.1.4, and v4.1.5 that could affect equipment performance.

    Product
    Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2380-2016·2016-08-17

    Philips Brilliance 64 CT Scanner Software Recall

    Philips is recalling Brilliance 64 CT scanners due to software issues that could affect equipment performance.

    Product
    Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2368-2016·2016-08-17

    Philips Brilliance BigBore CT Systems Recalled for Software Defect

    Philips Medical Systems is recalling 17 Brilliance BigBore CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-2344-2016·2016-08-17

    Siemens Artis Angiography Systems Recalled for Image Reproduction Failure

    Siemens Medical Solutions is recalling 51 Artis zee and Artis Q angiography systems due to a software error that may cause image loss after startup.

    Product
    Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee / zeego and Q/ Q.zen is a family of dedicated angiography systems developed for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2384-2016·2016-08-17

    Philips Ingenuity CT Software Recall for Performance Issues

    Philips is recalling Ingenuity Core128 CT scanners due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.

    Product
    Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2372-2016·2016-08-17

    Philips Ingenuity Core 128 CT Systems Recalled for Software Defect

    Philips is recalling five Ingenuity Core 128 CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-2346-2016·2016-08-17

    Philips MX 16-slice CT System Software Recall for Data Integrity Issues

    Philips is recalling 899 MX 16-slice CT systems due to software defects that may cause patient image mix-ups or scan interruptions.

    Product
    MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2394-2016·2016-08-17

    Siemens AXIOM Artis X-Ray Systems Recalled for Cooling System Contamination

    Siemens is recalling AXIOM Artis angiography systems because biomass contaminants in the cooling system may damage the pump.

    Product
    ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2364-2016·2016-08-17

    Invacare Pediatric Flowmeter Recalled for Upside-Down Rear Scale Printing

    Invacare is recalling 395 Precise Rx Pediatric Flowmeters because the rear gradation scale was printed upside down, which may cause confusion during oxygen flow monitoring.

    Product
    lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the…
    Category
    Medical Device
    Distribution
    30 states