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

Category

Minimum severity

Clear filters

27401–27425 of 40233

  • ModerateFDA (Devices)·Z-1411-2017·2017-03-15

    Mako Surgical Recalls MAKO RIO THA Application User Guides

    Mako Surgical Corporation is recalling 777 MAKO RIO THA Application User Guides because five AFMEA Risk Control Measures are missing from the documents.

    Product
    MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1426-2017·2017-03-15

    Merge Unity PACS Software Recalled for Missing Demographic Data

    Merge Healthcare is recalling Unity PACS software version 11.0 because reports faxed to referring physicians were missing demographic header information.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1412-2017·2017-03-15

    Encore Medical Recalls Turon Impaction Fixtures Due to Material Wear

    Encore Medical is recalling 297 Turon Impaction Fixtures because polymer material wore off during assembly, potentially affecting the humeral stem coating.

    Product
    Turon Impaction Fixture
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1400-2017·2017-03-15

    Remel Haemophilus Test Medium Recalled for Poor Organism Growth

    Remel Inc is recalling Haemophilus Test Medium agar plates because poor organism growth may result in incorrect susceptibility test results.

    Product
    Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1402-2017·2017-03-15

    Metrex Recalls CaviWipes Extra Large Due to Packaging Contamination

    Metrex Research is recalling CaviWipes Extra Large surface disinfectants because they may have been contaminated during the packaging process.

    Product
    CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1403-2017·2017-03-15

    Merge Cardio software recalled for incorrect measurement units in reports

    Merge Healthcare is recalling Merge Cardio software versions 9.0 and 10.0 because measurements from images or US carts do not transfer to reports in the correct unit of measure.

    Product
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1424-2017·2017-03-15

    Siemens Biograph Mobile PET/CT Recall for Missing Instructions

    Siemens is recalling nine Biograph Mobile PET/CT systems because mobile-specific instructions were not shipped to a limited population of devices.

    Product
    Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1431-2017·2017-03-15

    Merge PACS Software Recalled for Telmed Protocol Data Propagation Failures

    Merge Healthcare is recalling specific versions of Merge PACS software because studies may fail to propagate or import via the telmed protocol.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1438-2017·2017-03-15

    Abbott Recalls CELL-DYN Ruby Hematology Analyzers Due to Pump Relay Failure

    Abbott Laboratories is recalling 116 CELL-DYN Ruby hematology analyzers because the Pump Relay PCBA may prematurely fail, causing the instrument to stop working.

    Product
    CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1422-2017·2017-03-15

    Siemens Biograph 6 TruePoint PET/CT Recall for Missing Instructions

    Siemens is recalling 18 Biograph 6 TruePoint mobile PET/CT systems because mobile-specific instructions were not shipped to a limited population.

    Product
    Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1425-2017·2017-03-15

    Siemens Biograph Mobile PET/CT Recall for Missing Instructions

    Siemens is recalling four Biograph Mobile PET/CT units because specific mobile instructions were not shipped to a limited population.

    Product
    Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1419-2017·2017-03-15

    Siemens Progesterone Test Recalled Due to DHEA-S Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista LOCI Progesterone tests because DHEA-S causes falsely elevated results.

    Product
    Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1418-2017·2017-03-15

    Siemens ADVIA Centaur Progesterone Test Recalled for DHEA-S Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Progesterone tests because DHEA-S causes falsely elevated results.

    Product
    ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1423-2017·2017-03-15

    Siemens Biograph Mobile PET/CT Recall for Missing Instructions

    Siemens Medical Solutions is recalling six Biograph Mobile PET/CT units because mobile-specific instructions were not shipped to a limited population of systems.

    Product
    Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1410-2017·2017-03-15

    Integra UNI-CP System Recalled for Incorrect Labeling

    Integra LifeSciences Corp. is recalling 39 units of the UNI-CP System due to incorrect labeling on the plate.

    Product
    The UNI-CP System; Model Number: 330230SND.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1416-2017·2017-03-15

    US Endoscopy Recalls Roth Net Polyp Retrieval Due to Date Mismatch

    US Endoscopy Group Inc is recalling Roth Net Polyp Retrieval devices because the expiration date on the outer carton is shorter than the date on the inner package.

    Product
    Roth Net Polyp Retrieval
    Category
    Medical Device
    Distribution
    15 states
  • SevereFDA (Devices)·Z-1368-2017·2017-03-08

    Windstone Medical Packaging Recalls Shoulder Arthroscopy Packs Due to Sterility Risk

    Windstone Medical Packaging is recalling 606 Shoulder Arthroscopy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C Shoulder Arthroscopy Pack, part number AMS2609 Shoulder Arthroscopy Pack, part number AMS3857 Shoulder Arthroscopy Pack, part…
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-1329-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.

    Product
    Lap/Pelviscopy Pack, part number PSS3256(B
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-1251-2017·2017-03-08

    Olympus Recalls URF-P6 Uretero-reno Fiberscopes Due to Tissue Trauma Risk

    Olympus is recalling URF-P6 and URF-P6R uretero-reno fiberscopes due to adverse events involving tissue trauma and stuck insertion tubes reported in similar devices.

    Product
    URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0788-2017·2017-03-08

    Medtronic SynchroMed II Software Card Recall for Priming Bolus Function

    Medtronic is recalling 22,298 SynchroMed II software application cards to update the priming bolus function and pump labeling.

    Product
    Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1379-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are being recalled because splits or holes may compromise sterility.

    Product
    Upper Torso Tray, part number PSS1554(B
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-1252-2017·2017-03-08

    Olympus Uretero-reno Videoscope Recall Due to Insertion Tube Breakage

    Olympus is recalling URF-V2 and URF-V2R endoscopes because the insertion tube bending section may break during surgery, causing tissue trauma.

    Product
    Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2017·2017-03-08

    Windstone Medical Packaging Recalls Podiatry Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 2,018 Podiatry Packs because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS3785(C Podiatry Pack, part number AMS4011(A Podiatry Pack, part number PSS3422(A
    Category
    Medical Device
    Distribution
    26 states