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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25476–25500 of 40233

  • HighFDA (Devices)·Z-0102-2018·2017-11-22

    Zimmer Biomet Recalls ROSA Surgical Device Due to Navigation Software Shift

    Zimmer Biomet is recalling 21 ROSA Surgical Devices because an undetected shift between the navigation software display and actual patient anatomy was identified.

    Product
    ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0100-2018·2017-11-22

    Zimmer Biomet Recalls ROSA Surgical Device Due to Optical Sensor Failure

    Zimmer Biomet is recalling 14 ROSA Surgical Devices because a cable disconnection may cause the optical distance sensor to fail.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0096-2018·2017-11-22

    Zimmer Biomet ROSA Surgical Device Recalled for Potential Force Sensor Break

    Zimmer Biomet is recalling 21 ROSA Surgical Devices due to a possible break in the Force Sensor connector. The devices were distributed to facilities in Ohio, Michigan, and Texas.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0091-2018·2017-11-22

    Beckman Coulter AQUIOS CL Flow Cytometer Recalled for Sample Misidentification Risk

    Beckman Coulter is recalling 268 AQUIOS CL Flow Cytometers because the system may duplicate sample requests, leading to sample misidentification when connected to a Laboratory Information System.

    Product
    AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0099-2018·2017-11-22

    Zimmer Biomet Recalls ROSA Surgical Devices Due to Observed Instability

    Zimmer Biomet is recalling 53 ROSA Surgical Devices because of observed instability. The devices are computer-controlled arms used in neurosurgery.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0101-2018·2017-11-22

    ICU Medical Recalls Plum 360 Infusion Systems Due to Software Malfunction

    ICU Medical is recalling 21,461 Plum 360 Infusion Systems because a software defect can prevent users from stopping the pump or restarting delivery under specific conditions.

    Product
    Plum 360 Infusion System, List number 30010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0092-2018·2017-11-22

    Smith & Nephew Legion Knee Wedge Recalled for Incorrect Screw Size

    Smith & Nephew is recalling 10 units of the Legion L-Wedge Size 4 because they contained 5MM screws instead of the required 10MM screws.

    Product
    smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0103-2018·2017-11-22

    Terumo BCT Bone Marrow Procedure Pack Recall for Labeling Errors

    Terumo BCT is recalling specific bone marrow procedure packs because patient labels contain incorrect lot numbers, catalog numbers, and expiry dates.

    Product
    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0104-2018·2017-11-22

    Terumo BCT Recalls Bone Marrow Procedure Packs Due to Labeling Errors

    Terumo BCT is recalling 281 bone marrow procedure packs because the patient labels contain incorrect lot numbers, catalog numbers, and expiration dates.

    Product
    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0094-2018·2017-11-22

    Siemens Symbia Intevo 6 SPECT/CT Software Recall for Data Input Error

    Siemens is recalling two Symbia Intevo 6 SPECT/CT systems because a software option may prevent users from modifying specific data input values during calibration.

    Product
    Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0097-2018·2017-11-22

    Smith & Nephew Recalls Intertan 10S Orthopedic Nails Due to Assembly Error

    Smith & Nephew is recalling 17 units of Intertan 10S orthopedic nails because the set screw was inserted upside down during manufacturing.

    Product
    smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0093-2018·2017-11-22

    Siemens Symbia Intevo 16 SPECT/CT Software Recall for Data Input Error

    Siemens is recalling two Symbia Intevo 16 SPECT/CT systems because a software option may prevent users from modifying specific data input values.

    Product
    Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0098-2018·2017-11-22

    Karl Storz Recalls Mislabeled High Flow Insufflation Tubing Pouches

    Karl Storz Endoscopy is recalling 496 boxes of High Flow Insufflation Tubing because some inner pouches are mislabeled with the wrong catalog number.

    Product
    STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0095-2018·2017-11-22

    Arthrex iBalance UKA Knee Implant Recalled for Incorrect Patient Labeling

    Arthrex is recalling 20 units of iBalance UKA knee implants due to incorrect part numbers and sizes printed on the patient label.

    Product
    iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from…
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-0069-2018·2017-11-15

    Windstone Medical Recalls Custom Surgical Kits Due to Sterile Barrier Breach

    Windstone Medical Packaging is recalling 60 custom surgical kits containing a recalled catheter component due to a potential sterile barrier breach.

    Product
    AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0063-2018·2017-11-15

    North Star Imaging X-7000 Industrial X-Ray System Recalled for Radiation Leak

    North Star Imaging is recalling three Model X-7000 industrial cabinet x-ray systems due to a discovered low-level radiation leak.

    Product
    North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0083-2018·2017-11-15

    Teleflex Auto Endo5 Clip Applier Recalled for Clip Misalignment

    Teleflex Medical is recalling 13,710 units of the Auto Endo5 Automatic Hem-o-lok Clip Applier because clips may misalign, jam, or fall out of the device.

    Product
    WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0075-2018·2017-11-15

    Terumo BCT Recalls Harvest Graft Delivery Packs Due to Seal Defect

    Terumo BCT is recalling 525 Harvest Graft Delivery Packs because some lots may lack a seal on the inner pouch, potentially compromising sterility.

    Product
    HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2018·2017-11-15

    Lima Delta Cup Beater Positioner Recalled for Potential Welding Defects

    Lima is recalling 20 Delta Cup Beater Positioner units in the US due to suboptimal welding that may reduce mechanical strength and cause breakage during use.

    Product
    Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0076-2018·2017-11-15

    Sorin FlexFlow Venous Cannula Recalled for Sharpness Defect

    Sorin Group USA is recalling a specific lot of FlexFlow Venous Cannulas because they are sharper or pointier than expected.

    Product
    FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0065-2018·2017-11-15

    Encore Medical Recalls Cobalt MV Bone Cement Due to Packaging Seal Loss

    Encore Medical is recalling 840 units of Cobalt MV Bone Cement because the sterile Tyvek packaging seal may be lost, potentially compromising sterility.

    Product
    Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0078-2018·2017-11-15

    Boston Scientific Recalls 12 Resonate EL ICD Devices for Firmware Error

    Boston Scientific is recalling 12 Resonate EL ICD DR devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    RESONATE EL ICD DR, Model D433, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0087-2018·2017-11-15

    Epimed RX-2 COUDE Epidural Needle Recalled for Potential Sterility Seal Defect

    Epimed International is recalling 500 units of RX-2 COUDE Epidural Needles due to a potential incomplete seal that may impact sterility.

    Product
    RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0070-2018·2017-11-15

    Zimmer Biomet Recalls Custom Titanium Knee Implant Due to Nickel Content

    Zimmer Biomet is recalling a custom titanium knee implant because it contained a nickel-containing screw, posing a risk to a patient with a nickel allergy.

    Product
    Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0067-2018·2017-11-15

    Encore Medical Recalls Cobalt Bone Cement Due to Packaging Seal Loss

    Encore Medical, Lp is recalling Cobalt HV with Gentamicin bone cement because the sterile Tyvek packaging may have lost its seal, potentially compromising sterility.

    Product
    Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic…
    Category
    Medical Device
    Distribution
    Distributed nationwide