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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26276–26300 of 40357

  • 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
  • HighFDA (Devices)·Z-2605-2017·2017-06-28

    Medtronic Recalls MiniMed 670G Insulin Pumps Due to Keypad Issues

    Medtronic is recalling 117,239 MiniMed 670G insulin pumps because the keypad may become unresponsive and the pump may become temporarily stuck.

    Product
    MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2619-2017·2017-06-28

    DePuy Mitek LATARJET Extraction Driver Recalled for Breakage Risk

    DePuy Mitek is recalling 115 units of the LATARJET EXPERIENCE Extraction Driver because the tip may break during surgery when used at an angle.

    Product
    DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 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-2621-2017·2017-06-28

    Omega Medical Imaging Recalls Elevating Monitor Suspension Pillars

    Omega Medical Imaging is recalling 6 units of 2 over 2 Elevating Monitor Suspension pillars because the column may drop and fail to rise.

    Product
    Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2603-2017·2017-06-28

    Medtronic Recalls MiniMed 630G Insulin Pumps Due to Keypad Malfunction

    Medtronic is recalling 65,959 MiniMed 630G insulin pumps because the device may become temporarily stuck and the keypad may become unresponsive.

    Product
    MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2618-2017·2017-06-28

    DePuy Mitek Top Hat Tap Screw Driver Tip Recall

    DePuy Mitek is recalling 153 units of the LATARJET EXPERIENCE Top Hat Tap because the Combo Screw Driver tip may break during surgery.

    Product
    DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 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-2604-2017·2017-06-28

    Medtronic Recalls MiniMed 640G Insulin Pumps Due to Keypad Malfunction

    Medtronic is recalling 117,239 MiniMed 640G insulin pumps because the keypad may become unresponsive, potentially preventing users from adjusting insulin delivery.

    Product
    MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2592-2017·2017-06-28

    Ion Beam Applications Recalls Proteus 235 Medical Devices

    Ion Beam Applications S.A. is recalling 18 Proteus 235 systems due to potential dark current issues in Pencil Beam Scanning mode.

    Product
    Proteus 235
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2615-2017·2017-06-28

    DePuy Mitek LATARJET Combo Screw Driver Recalled for Breakage Risk

    DePuy Mitek is recalling 173 LATARJET Combo Screw Drivers because the tip may break during surgery when used at an angle.

    Product
    DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 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
  • ModerateFDA (Devices)·Z-2613-2017·2017-06-28

    Abbott Recalls ARCHITECT SHBG Reagent Due to Specimen Tube Interference

    Abbott Laboratories is recalling 7,981 kits of ARCHITECT SHBG Reagent because using Potassium EDTA specimen tubes may cause falsely decreased test results.

    Product
    ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2609-2017·2017-06-28

    Siemens Ferritin Cartridge Recalled for Incorrect Biotin Interference Labeling

    Siemens Healthcare Diagnostics is recalling Dimension Vista Ferritin reagent cartridges because the instructions for use contain incorrect units and levels for biotin interference.

    Product
    Dimension Vista Ferritin (FERR) Flex reagent cartridge
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2608-2017·2017-06-28

    Siemens Dimension Vista Estradiol Reagent Cartridge Recall for Labeling Error

    Siemens Healthcare Diagnostics is recalling Dimension Vista Estradiol reagent cartridges because the instructions for use contain incorrect biotin interference units.

    Product
    Dimension Vista Estradiol (E2) Flex reagent cartridge
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2611-2017·2017-06-28

    Siemens Dimension Vista TSH Reagent Cartridge Recall for Incorrect Biotin Units

    Siemens is recalling Dimension Vista TSH reagent cartridges because the instructions for use list incorrect units and interference levels for biotin.

    Product
    Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
    Category
    Medical Device
    Distribution
    0 states