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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8551–8575 of 13731

  • 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-2440-2023·2023-08-30

    FilmArray Pneumonia Panel Recalled Due to Manufacturing Defect Causing False Negatives

    BioFire Diagnostics recalled FilmArray Pneumonia Panel diagnostic kits due to a manufacturing defect that may produce false negative results, potentially causing missed pneumonia diagnoses.

    Product
    FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
    Category
    Medical Device
    Distribution
    24 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-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
  • 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-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-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-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-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-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-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-2442-2023·2023-08-30

    EMBLEM MRI S-ICD Pulse Generator Recall for Rare Sensing Disablement

    Boston Scientific recalls the EMBLEM MRI S-ICD Pulse Generator due to a rare interaction with the LATITUDE communicator that may disable the device's sensing capability for up to 24 hours.

    Product
    EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    0 states
  • 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-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
  • 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
  • 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-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-2369-2023·2023-08-23

    Dialysis Catheter Recalled Due to Silicone Lubricant Obstruction Risk

    Covidien LP is recalling 5,373 MAHURKAR dialysis catheters because excessive silicone lubricant can occlude the catheter lumen, potentially causing treatment delays or blood clotting complications.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2386-2023·2023-08-23

    MAHURKAR dialysis catheters recalled for center lumen occlusion risk

    Covidien LP recalls MAHURKAR dialysis catheters due to excessive silicone lubricant on the catheter tip, which can obstruct the center lumen. This may delay treatment and cause serious blood complications including embolism and thrombosis.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2385-2023·2023-08-23

    Acute Dialysis Catheter Recalled for Potential Lumen Obstruction and Embolism Risk

    Covidien is recalling MAHURKAR acute dialysis catheters for excessive silicone lubricant causing lumen obstruction that may delay treatment and lead to hemolysis, embolism, or thrombosis.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2391-2023·2023-08-23

    Dialysis Catheter Recalled for Center Lumen Occlusion Risk

    Covidien LP is recalling 3,965 MAHURKAR dialysis catheters due to excessive lubricant causing center lumen occlusion. This may obstruct blood flow or cause hemolysis and blood clots.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2382-2023·2023-08-23

    Mahurkar Dialysis Catheter Center Lumen Occlusion, FDA Class I Recall

    Covidien's Mahurkar dialysis catheters are recalled due to center lumen occlusion from excessive silicone lubricant, risking treatment delay and serious vascular complications.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2374-2023·2023-08-23

    Dialysis Catheter Recall: Center Lumen Occlusion Due to Excessive Lubricant

    Covidien LP is recalling MAHURKAR 12 Fr dialysis catheters due to center lumen occlusion from excessive lubricant. The defect may cause treatment delays and serious complications including embolism and thrombosis.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2377-2023·2023-08-23

    Acute Dialysis Catheters Recalled for Catheter Tip Occlusion

    Covidien recalls 519 MAHURKAR acute dialysis catheters (Lot 2200400292) due to excessive silicone lubricant coating the catheter tip that may cause partial or full occlusion and treatment delays.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
    Category
    Medical Device
    Distribution
    Distributed nationwide