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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

7226–7250 of 27364

  • 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-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
  • HighFDA (Devices)·Z-2448-2023·2023-08-30

    FDA Recalls Randox Liquid Protein Calibrators for Measurement Accuracy Error

    Randox Laboratories recalled 166 units of Liquid Protein Calibrators (IT2691) after restandardization caused Ferritin results to read approximately 10% higher than targeted calibrator values.

    Product
    Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691
    Category
    Medical Device
    Distribution
    9 states
  • 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-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-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-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-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-2439-2023·2023-08-30

    BioFire Respiratory Panel 2.1 may produce false negative results

    BioFire Respiratory Panel 2.1 kits for FILMARRAY systems may return false negative results due to a manufacturing defect. The recall affects 705 kits distributed to healthcare facilities in the U.S. and select international locations.

    Product
    BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, 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-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
  • 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-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-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-2380-2023·2023-08-23

    FDA Recalls Mahurkar Dialysis Catheter for Potential Tip Obstruction Risk

    Covidien's Mahurkar acute dialysis catheters may have excessive silicone lubricant causing tip obstruction. This could delay treatment or cause serious complications including blood clots and embolism.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2388-2023·2023-08-23

    Dialysis Catheter Recall Due to Center Lumen Occlusion

    Covidien is recalling MAHURKAR Triple Lumen Acute Dialysis Catheters due to excessive lubricant blocking the center lumen, which may delay dialysis and cause blood clots. The recall affects 6,949 units distributed in the US and worldwide.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
    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-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-2387-2023·2023-08-23

    Dialysis Catheters Recalled by FDA for Tip Obstruction Risk

    Covidien is recalling MAHURKAR acute dialysis catheters because the center lumen tip may be occluded by excessive silicone-based lubricant. Obstruction could delay treatment or cause embolism and thrombosis.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888345611HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2411-2023·2023-08-23

    Alcon Custom Pak Intraocular Lens Packages Recalled for Plastic Debris Risk

    Alcon Custom Pak intraocular lens packages are recalled due to reports of patient injury during surgical procedures caused by plastic debris from over-tightening with the included plastic wrench.

    Product
    Alcon Custom Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2376-2023·2023-08-23

    Mahurkar Dialysis Catheters Recalled for Center Lumen Obstruction

    Covidien is recalling 1,099 MAHURKAR dialysis catheters worldwide due to excessive silicone lubricant that can block the center lumen, potentially delaying treatment.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2367-2023·2023-08-23

    Covidien MAHURKAR Dialysis Catheter Recalled for Lumen Occlusion Risk

    Covidien is recalling dialysis catheters with excessive lubricant in the center lumen, which may cause occlusion, obstruct blood flow, and delay treatment.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2379-2023·2023-08-23

    Dialysis Catheters Recalled Due to Excessive Lubricant Causing Obstruction

    Covidien is recalling MAHURKAR dialysis catheters that may have excessive lubricant coating the catheter tip, potentially causing dangerous blockages that delay treatment or lead to serious complications.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2408-2023·2023-08-23

    Infinity FMS Pak surgical device recalled for plastic debris hazard

    Alcon is recalling the Infinity FMS Pak surgical device after reports of patient injuries during procedures caused by plastic debris from over-tightening the included wrench. The recall affects 51,054 units distributed worldwide.

    Product
    Infinity FMS Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide