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 deaths or serious injuries are reported, 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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Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

8476–8500 of 13652

  • HighFDA (Devices)·Z-2449-2023·2023-08-30

    O-arm O2 Imaging System Ground Cable Installation Defect Recall

    Medtronic is recalling O-arm O2 imaging systems due to an incorrectly installed ground cable. The defect affects 28 units distributed across the US and internationally.

    Product
    The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2023·2023-08-30

    Intervertebral fusion device recalled for packaging non-conformity issue

    Medicrea International is recalling 4,489 IMPIX MANTA intervertebral fusion devices due to potential pinholes in product packaging that could compromise device sterility.

    Product
    IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2447-2023·2023-08-30

    Air/Water Valve Used with Olympus Endoscopes May Malfunction

    Olympus air/water valves used with ultrasonic endoscopes may fail during automated reprocessing, potentially allowing body fluids to backflow into the air channel. Approximately 29,590 units nationwide are affected.

    Product
    The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2459-2023·2023-08-30

    Medicrea GRANVIA-C Cervical Fusion Device Recalled for Packaging Defects

    Medicrea International is recalling GRANVIA-C cervical intervertebral fusion devices due to a packaging non-conformity issue presenting as pinholes in inner or outer pouches, which could compromise sterility.

    Product
    GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿¿¿¿¿ B13111014, h)¿¿¿¿ B13111015, i)¿¿¿¿¿¿ B13111016, j)¿¿¿¿¿¿ B13111017, k)¿¿¿¿¿ B13111025, l)¿¿¿¿¿¿ B13111026, m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2430-2023·2023-08-30

    Infusion pump alarm may fail to sound due to manufacturing defect

    ICU Medical recalls approximately 93,135 Plum 360 infusion pumps due to a manufacturing defect that could prevent alarm signals from sounding. The devices were manufactured between July 2020 and December 2021.

    Product
    Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 300101114, 300101313, 300101379, 300102213, 300102713, 300102913, 300103413, 30010341
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2462-2023·2023-08-30

    Medicrea IMPIX MANTA+ Cervical Fusion Devices Recalled for Packaging Defect

    Medicrea International is recalling IMPIX MANTA+ cervical intervertebral fusion devices due to potential packaging non-conformity with pinholes in inner or outer pouches. No illnesses or injuries reported.

    Product
    IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; intervertebral fusion device - cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2441-2023·2023-08-30

    EMBLEM S-ICD Pulse Generator May Lose Heart Sensing for 24 Hours

    Boston Scientific is recalling 3,856 EMBLEM S-ICD heart devices due to a rare interaction with the LATITUDE communicator that may disable sensing of dangerous heart rhythms for up to 24 hours.

    Product
    EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2455-2023·2023-08-30

    IMPIX DLIF Intervertebral Fusion Device Recalled for Packaging Defect

    Medicrea International is recalling IMPIX DLIF intervertebral fusion devices due to potential pinholes in product packaging that could compromise sterility.

    Product
    IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2460-2023·2023-08-30

    Medicrea IMPIX C+ Cervical Fusion Device Recalled for Packaging Defect

    Medicrea is recalling IMPIX C+ cervical intervertebral fusion devices due to a potential packaging non-conformity that presents as a pinhole in the product pouch. The defect could affect product integrity for this implantable device.

    Product
    IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2443-2023·2023-08-30

    Femur nail surgical implant mislabeled with incorrect product length

    Smith & Nephew recalled a femur nail surgical implant because some packages contained a 40cm product instead of the labeled 36cm version. No injuries have been reported.

    Product
    TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2452-2023·2023-08-30

    IMPIX 3D spinal implant recalled for packaging pinhole defect

    Medicrea International is recalling 248 units of IMPIX 3D intervertebral fusion devices due to pinholes in the product packaging. The recall covers devices distributed nationwide.

    Product
    IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810, l) B242C15122810, m) B247C07062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2451-2023·2023-08-30

    ADVIA Chemistry Urinary Protein Reagent Carryover Causing Incorrect Creatinine Results

    A reagent carryover issue in Siemens ADVIA Chemistry urinary protein test kits can cause falsely low creatinine test results. The problem occurs when the creatinine test is run after the protein test on the same system.

    Product
    ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2023·2023-08-30

    Femoral nail implant recalled for product labeling and packaging mismatch

    Smith & Nephew is recalling 32 units of a femoral nail implant due to labeling mismatch. The package contained 40cm implants but was labeled as 36cm, which could result in incorrect surgical implantation.

    Product
    TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2458-2023·2023-08-30

    Medicrea Cervical Fusion Implants Recalled for Packaging Defect

    Medicrea International is recalling 963 PASS LP cervical fusion implants due to potential pinholes in the device packaging. The recall affects units distributed nationwide.

    Product
    PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2446-2023·2023-08-30

    Randox Liquid Urine Control Level 2 Recalled for Analytical Accuracy Issues

    Randox Liquid Urine Control Level 2 (Lot 1209UC) is recalled for incorrect hCG and cortisol values and a transcription error in instructions. The defects may delay patient test reporting.

    Product
    Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2445-2023·2023-08-30

    Dolomite Gloss Rollator Structural Failure Recall: Seat Collapse Risk

    Dolomite Gloss Rollator models may experience seat failure and structural collapse due to broken eyelets and crossbar, potentially causing user injury. About 586 units nationwide are affected.

    Product
    DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2454-2023·2023-08-30

    Intervertebral Fusion Device Recalled for Potential Packaging Defect

    Medicrea International is recalling 5 units of IMPIX ALIF intervertebral fusion devices due to a potential packaging defect—a pinhole in the inner or outer pouch.

    Product
    IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2461-2023·2023-08-30

    Cervical intervertebral fusion devices recalled for packaging defect

    Medicrea International is recalling IMPIX S cervical intervertebral fusion devices due to a potential packaging defect involving pinholes in the inner or outer pouch. No injuries have been reported.

    Product
    IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2023·2023-08-30

    Medicrea IMPIX ALIF Lumbar Fusion Devices Recalled for Packaging Defect

    Medicrea International is recalling 11 IMPIX ALIF lumbar intervertebral fusion devices distributed nationwide due to a potential packaging defect with pinholes in the device pouch.

    Product
    IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2457-2023·2023-08-30

    Medicrea Recalls IMPIX TLIF Fusion Devices for Packaging Defects

    Medicrea International is recalling IMPIX TLIF intervertebral fusion devices due to potential packaging defects. The devices may have pinholes in the inner or outer packaging pouches.

    Product
    IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2383-2023·2023-08-23

    FDA Recalls Dialysis Catheters for Center Lumen Obstruction Risk

    Covidien is recalling MAHURKAR dialysis catheters because the center lumen may be blocked by excess silicone lubricant. This could delay treatment and cause blood clots, hemolysis, or embolism.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2372-2023·2023-08-23

    FDA Recalls MAHURKAR Dialysis Catheters Over Obstruction Defect Risk

    Covidien's MAHURKAR dialysis catheters are recalled due to excessive lubricant on the catheter tip causing partial or complete obstruction. This risks delaying treatment and may cause blood clots, hemolysis, or embolism.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2378-2023·2023-08-23

    Dialysis catheter recall: excessive lubricant causes center lumen obstruction

    A dialysis catheter product is being recalled due to excessive lubricant coating in the center lumen, which may cause full or partial obstruction. The blockage could delay treatment and increase risk of blood clots and hemolysis.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2384-2023·2023-08-23

    Dialysis catheters recalled for potential center lumen obstruction

    Covidien LP is recalling MAHURKAR dialysis catheters because excessive silicone lubricant coats the center lumen, potentially blocking blood flow or creating clots and other blood vessel complications.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2370-2023·2023-08-23

    Dialysis catheter recalled due to potential tip occlusion risk

    Covidien is recalling MAHURKAR dialysis catheters that may have excessive lubricant in the catheter tip, potentially causing obstruction. This could delay treatment or cause serious blood complications including thrombosis or embolism.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HP
    Category
    Medical Device
    Distribution
    Distributed nationwide