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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26176–26200 of 40233

  • HighFDA (Devices)·Z-2630-2017·2017-07-05

    Intuitive Surgical Recalls da Vinci Xi Surgical Systems Due to Brake Screw Issue

    Intuitive Surgical is recalling 10 da Vinci Xi Surgical Systems because brake screws on the patient side carts may be under-torqued.

    Product
    da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2654-2017·2017-07-05

    Shimadzu RADspeed Pro X-Ray Systems Recalled for Tube Shaft Cracks

    Shimadzu is recalling RADspeed Pro stationary x-ray systems because cracks may develop on the tube holding shaft, posing a risk of equipment failure.

    Product
    SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2642-2017·2017-07-05

    Merge Healthcare Recalls Pediatric SpO2 Sensors for Display Failure

    Merge Healthcare is recalling four MasimoSET pediatric SpO2 sensors because cables may stop displaying patient data, causing slight delays in care.

    Product
    MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2622-2017·2017-07-05

    Recall of Covidien Endo Peanut 5mm Auto Suture Blunt Dissector

    Covidien LLC is recalling 194,851 units of the Endo Peanut 5mm Auto Suture Blunt Dissector because the cotton tip may disengage due to insufficient adhesive.

    Product
    Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2655-2017·2017-07-05

    Shimadzu FDR Visionary X-Ray System Recalled for Tube Shaft Cracks

    Shimadzu is recalling FDR Visionary x-ray systems because cracks may develop on the tube holding shaft. The recall covers 1,673 units distributed in the US, Canada, and Japan.

    Product
    SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2643-2017·2017-07-05

    Merge Healthcare Recalls MasimoSET SpO2 Sensors for Display Issues

    Merge Healthcare is recalling 65 MasimoSET LNOP DCI adult SpO2 reusable sensors because cables may stop displaying patient SpO2, causing slight delays in care.

    Product
    MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2652-2017·2017-07-05

    AGFA Healthcare Recalls IMPAX Cardiovascular Software Due to Incorrect Findings

    AGFA Healthcare Corp. is recalling 10 units of IMPAX Cardiovascular software because it displayed incorrect aneurysm findings in NIV reports.

    Product
    IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2636-2017·2017-07-05

    Beckman Coulter Access Thyroglobulin Recalled for Biotin Interference

    Beckman Coulter is recalling Access Thyroglobulin immunoassays because they are susceptible to biotin interference, which may affect test results.

    Product
    Access Thyroglobulin, A34085G, Catalog No. 33860
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2647-2017·2017-07-05

    Onkos Surgical Recalls Mislabelled Limb Salvage System Segmental Stems

    Onkos Surgical is recalling four units of the Eleos Limb Salvage System Segmental Stem due to incorrect collar size labeling.

    Product
    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2646-2017·2017-07-05

    Onkos Surgical Recalls ELEOS Limb Salvage System Segmental Stem Due to Labeling Error

    Onkos Surgical is recalling four units of the ELEOS Limb Salvage System Segmental Stem because the device collar size was incorrectly labeled as 25 mm instead of 32 mm.

    Product
    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2632-2017·2017-07-05

    3M Ranger Pressure Infusor Recalled for Pressure Specification Deviation

    3M is recalling one Ranger Pressure Infusor, Model 145, because it produced pressure slightly below manufacturing specifications.

    Product
    3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2641-2017·2017-07-05

    Merge Healthcare Recalls Masimo SPO2 Sensors for Display Failure

    Merge Healthcare is recalling Masimo SPO2 ear clip sensors because cables may stop displaying SpO2 readings, causing slight delays in patient care.

    Product
    Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2644-2017·2017-07-05

    Exactech Novation Calcar Planer Guide Tip Recalled for Labeling Clarification

    Exactech is recalling 477 Novation Calcar Planer Guide Tips to update labeling with a caution about instrument breakage.

    Product
    Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2638-2017·2017-07-05

    Beckman Coulter Access System-GI Monitor Recalled for Biotin Interference

    Beckman Coulter is recalling Access System-GI Monitor (CA19-9) kits because they are susceptible to biotin interference, which may affect test results.

    Product
    Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2648-2017·2017-07-05

    Onkos Surgical Recalls Mislabelled Limb Salvage System Segmental Stem

    Onkos Surgical, Inc. is recalling four units of the Eleos Limb Salvage System Segmental Stem due to incorrect collar size labeling.

    Product
    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-2623-2017·2017-07-05

    CryoLife BioGlue Surgical Adhesive Recalled for Incorrect Lot Labeling

    CryoLife, Inc. is recalling 705 boxes of BioGlue Surgical Adhesive because 9 boxes had incorrect lot numbers on their courtesy labels.

    Product
    BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2627-2017·2017-07-05

    Euro Diagnostica Recalls DIASTAT ANA Kits Due to Incorrect Expiration Date

    Euro Diagnostica AB is recalling 501 units of DIASTAT ANA kits because the packaging displayed the original expiration date instead of the shortened one.

    Product
    DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B)…
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-2650-2017·2017-07-05

    Medtest Liquid Creatine Kinase Reagent Set Recalled for Labeling Mismatch

    Medtest Holdings is recalling Pointe Scientific Liquid Creatine Kinase Reagent Sets because the product insert does not match the approved premarket notification.

    Product
    Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2631-2017·2017-07-05

    Medtest CRP Calibrator and Standard Sets Recalled for Unit Mislabeling

    Medtest Holdings is recalling Pointe Scientific CRP calibrator and standard sets because vial labels incorrectly list units as mg/dl instead of mg/L.

    Product
    Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the…
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-2649-2017·2017-07-05

    Medtest Holdings Recalls CK-MB Control Kits Due to Labeling Error

    Medtest Holdings is recalling five CK-MB Isoenzyme Control Kits because the product labeling contains an incorrect control range.

    Product
    The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2224-2017·2017-06-28

    Vascular Solutions Recalls Venture Catheters Due to Material Detachment Risk

    Vascular Solutions, Inc. is voluntarily recalling Venture RX, OTW, and CS catheters because material may detach from the distal tip during use.

    Product
    Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2616-2017·2017-06-28

    DePuy Mitek LATARJET Coracoid Drill Recalled for Breakage Risk

    DePuy Mitek is recalling LATARJET Coracoid Drills because the Combo Screw Driver tip may break during surgery.

    Product
    DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2617-2017·2017-06-28

    DePuy Mitek LATARJET Drill Tip Recall Due to Breakage Risk

    DePuy Mitek is recalling LATARJET Coracoid Top Hat Drills because the Combo Screw Driver tip may break during surgery.

    Product
    DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2602-2017·2017-06-28

    Medtronic Recalls MiniMed 620G Insulin Pumps Due to Keypad Malfunction

    Medtronic is recalling 6,573 MiniMed 620G insulin infusion pumps because the keypad may become unresponsive and the pump may become temporarily stuck.

    Product
    MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
    Category
    Medical Device
    Distribution
    0 states