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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6901–6925 of 13666

  • HighFDA (Devices)·Z-1369-2024·2024-04-03

    Cystatin C Calibrator Series CVS 2699 Recalled for Calibration Bias

    Randox Laboratories is recalling Cystatin C Calibrator Series CVS 2699 because it runs with negative bias compared to other methods, which could affect test accuracy on automated analyzers.

    Product
    Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1359-2024·2024-04-03

    Thermalon Eye Compress Recalled Due to Potential Mold and Mildew Growth

    Bruder Healthcare Company is recalling Thermalon Eye Compress Item 2434 from certain lots due to potential mold and mildew growth from excessive moisture exposure. Affected products were distributed in the US and Canada.

    Product
    Thermalon Eye Compress, Item Number 2434
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2024·2024-04-03

    Clinical Laboratory Quality Control Device Recalled for Diluent Assembly Error

    Ortho-Clinical Diagnostics is recalling 11,224 units of VITROS Performance Verifier II due to incorrect diluent assembly, which may produce inaccurate quality control results and potentially erroneous patient test results.

    Product
    VITROS Performance Verifier II
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1379-2024·2024-04-03

    Baxter Peri-Guard Repair Patch Contraindication Added for Neurosurgery

    Baxter Healthcare has added a contraindication to Peri-Guard Repair Patch instructions, restricting use in neurosurgery because endotoxin levels may exceed allowable limits for cerebrospinal fluid-contacting devices.

    Product
    Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1367-2024·2024-04-03

    MediBeads King Pad Moist Heat Compresses Recalled for Potential Mold Growth

    Bruder Healthcare is recalling MediBeads King Pad moist heat compresses (item numbers 34120, 34120PM, 34125R) from certain lots due to potential mold and mildew growth from excessive moisture exposure.

    Product
    MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2024·2024-04-03

    Endoscopic Lens Cleaner Recalled for Instruction Discrepancy Risk

    Olympus recalls InstaClear Lens Cleaner devices due to inconsistencies between Japanese and English instruction manuals that could cause component separation during endoscopic procedures.

    Product
    InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS4K30BTOL LCS1530TPOL LCS1830TPST LCS4K30TPOL LCS1545BTOL LCS1845BTST LCS4K
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1377-2024·2024-04-03

    Baxter Peri-Guard Repair Patch contraindicated for neurosurgical use

    Peri-Guard Repair Patch is now contraindicated for neurosurgery because its endotoxin level may exceed the limit allowable for cerebrospinal fluid-contacting devices. Product instructions have been updated.

    Product
    Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1380-2024·2024-04-03

    Baxter Supple Peri-Guard Repair Patch contraindicated for neurosurgery due to endotoxin

    Baxter is recalling specific lot codes of Supple Peri-Guard Repair Patch because endotoxin levels may exceed limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.

    Product
    Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1366-2024·2024-04-03

    MediBeads Neck Wrap recalled for potential mold and mildew growth

    Bruder Healthcare Company is recalling 430 units of MediBeads Neck Wrap (Item 34320) because the product may have been exposed to excessive moisture, creating potential for mold and mildew growth. Lot Number M053300, distributed in the US and Canada.

    Product
    MediBeads Neck Wrap, Item Number 34320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1396-2024·2024-04-03

    Certain OptiCross Coronary Imaging Catheters recalled for manufacturing defect

    Boston Scientific recalls certain batches of OptiCross Coronary Imaging Catheters manufactured with an incorrect voltage setting that may cause decreased image brightness.

    Product
    OptiCross Coronary Imaging Catheter, REF H749518080120
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1381-2024·2024-04-03

    Medivance Neonatal ArcticGel Pads Recalled for Reduced Water Flow

    Medivance Inc. is recalling Neonatal ArcticGel Pads due to reduced water flow that may prevent proper heating or cooling performance in neonatal temperature management systems. No injuries have been reported.

    Product
    Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1358-2024·2024-04-03

    Bio-Rad QXDx BCR-ABL diagnostic kit recalled for calibration errors

    Bio-Rad Laboratories is recalling a diagnostic test kit due to incorrect calibrations and controls that may produce inaccurate test results. Patients and healthcare providers should contact the manufacturer.

    Product
    Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2024·2024-04-03

    Epix Universal Clip Applier Recalled for Potential Clip Loading Failure

    Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load the surgical clip after the trigger is actuated. Units were distributed worldwide.

    Product
    Epix Universal Clip Applier, REF: CA500, STERILEEO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1384-2024·2024-04-03

    SOLTIVE Pro SuperPulsed Laser recalled for non-compliant power cord

    Olympus Corporation recalls the SOLTIVE Pro SuperPulsed Laser (TFL-SLS) due to a non-compliant power cord with incompatible plug configurations for the regions where affected units were distributed.

    Product
    SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1395-2024·2024-04-03

    Emergency traction splint adhesive failure may compromise device function

    Emergency Products & Research is recalling 190,000 O.T.D. traction splints because adhesive may fail to secure the pole insert, potentially compromising function in emergency medical situations.

    Product
    O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2024·2024-04-03

    RELAY PRO Thoracic Stent-Graft System recalled for incorrect size

    Bolton Medical Inc. is recalling 21 RELAY PRO Thoracic Stent-Graft Systems because the stent-graft inside the delivery system is the incorrect size.

    Product
    RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1362-2024·2024-04-03

    Thermalon Back Wrap Recalled for Potential Mold and Mildew Growth

    Certain lots of Thermalon Back Wrap may have been exposed to excessive moisture, potentially resulting in mold and mildew growth. The product is distributed nationwide in the US and Canada.

    Product
    Thermalon Back Wrap, Item Number 24312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1375-2024·2024-04-03

    Olympus Insufflation Unit UHI-4 Recalled for Air Supply Failure

    Olympus recalled 3,172 UHI-4 insufflation units due to the front panel LED turning off, which causes loss of air supply. All serial numbers nationwide are affected.

    Product
    Insufflation unit, UHI-4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2024·2024-04-03

    Thermalon Sinus Compress Recalled for Potential Mold and Mildew

    Bruder Healthcare Company is recalling 1,416 units of Thermalon Sinus Compress (Item Number 24332) due to potential mold and mildew growth from excessive moisture exposure. Affected lot numbers are M053160 and M053570.

    Product
    Thermalon Sinus Compress, Item Number 24332
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1390-2024·2024-04-03

    Boston Scientific iSLEEVE Expandable Introducer Sets Recalled for Hemostatic Valve Leak

    Boston Scientific is recalling specific batches of the iSLEEVE Expandable Introducer Set due to hemostatic valve leaks affecting 4,060 devices. The devices are distributed in the US, Canada, and worldwide.

    Product
    Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1389-2024·2024-04-03

    Epix Universal Clip Applier Recalled for Clip Load Failure Risk

    Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load a clip after the trigger is actuated, potentially impacting surgical procedures.

    Product
    Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - H¿PATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2024·2024-04-03

    Laboratory performance verifier recalled for mismatched diluent assembly

    Ortho-Clinical Diagnostics is recalling 10,911 units of VITROS Performance Verifier I worldwide due to mismatched diluent components that could cause inaccurate quality control test results.

    Product
    VITROS Performance Verifier I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2024·2024-04-03

    Alcon bulb irrigation syringes recalled due to sterile barrier compromise

    Alcon is recalling bulb irrigation syringes due to potential sterile barrier compromise in surgical procedure packs. Non-sterile syringes may increase infection risk.

    Product
    SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2024·2024-04-03

    Baxter Supple Peri-Guard Repair Patch Recall Due to Endotoxin Contraindication

    Baxter is recalling Supple Peri-Guard Repair Patch units due to elevated endotoxin levels that may exceed allowable limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.

    Product
    Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1391-2024·2024-04-03

    Puritan HydroFlock Collection Device Distributed with Wrong Product Code

    Puritan Medical Products distributed HydroFlock Sterile Flocked Collection Devices labeled as Part Number 25-3317-H, Lot S1014 that actually contain product code 25-3317-U. Approximately 232,500 units were affected.

    Product
    HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
    Category
    Medical Device
    Distribution
    Distributed nationwide