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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25551–25575 of 40357

  • HighFDA (Devices)·Z-0113-2018·2017-11-29

    Medline Suction Catheters Recalled for Sterilization Error

    Medline Industries is recalling 120 units of sterile suction catheters that were distributed before being sterilized.

    Product
    MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0161-2018·2017-11-29

    Zimmer Biomet Recalls ROSA Surgical Device Software

    Zimmer Biomet is recalling 29 ROSA Surgical Devices due to a software issue affecting cooperative endoscopy mode.

    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. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0165-2018·2017-11-29

    Abbott Clinical Chemistry Systems Recalled for Tubing Leak Risk

    Abbott is recalling 34 ARCHITECT c4000, c8000, and c16000 clinical chemistry systems because a manufacturing issue with the peristaltic head tubing may cause leaks.

    Product
    ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0169-2018·2017-11-29

    Resource Optimization Recalls Regard Custom Surgical Packs Due to Label Error

    Resource Optimization & Innovation LLC is recalling 51 units of Regard Custom Surgical Packs because they contain a 3ml ChloraPrep With Tint unit with an incorrect label.

    Product
    Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0168-2018·2017-11-29

    Siemens Recalls Syngo.plaza PACS Software Due to Image Count Discrepancy

    Siemens Medical Solutions is releasing a software tool to fix an issue where Syngo.plaza PACS displays fewer de-archived images than archived.

    Product
    Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0090-2018·2017-11-22

    WalkMed Infusion Pump Reservoir Bags Recalled for Fluid Leaks

    WalkMed, LLC is recalling 25,920 infusion pump reservoir bags due to reported fluid leaks at the luer connection.

    Product
    Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Part Number 204821 Catalog Number IPR-150/10 150 mL The WalkMed Reservoir Bag is designed for use with the WalkMed 350VL Ambulatory pump and is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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