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

3226–3250 of 39987

  • HighFDA (Devices)·Z-2508-2025·2025-09-10

    MediHoney hydrogel sheet dressings recalled over packaging failures compromising sterility

    MediHoney Adhesive Hydrogel Sheet Dressings, catalog numbers 31720 and 31740, are recalled after packaging failures were identified that could breach the sterile barrier. 994 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY¿ Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combinat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2494-2025·2025-09-10

    RayStation 6 service packs recalled over DICOM identifier uniqueness defect

    RayStation 6 Service Packs 1, 2 and 3 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation Thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2514-2025·2025-09-10

    Dental titanium bases recalled because the post is oriented 180 degrees off

    NobelBiocare Tri-Lobe-compatible WP 6.0mm engaging titanium bases, lot 277097, are recalled because the base was manufactured 180 degrees around the post from the correct position. 11 units are affected.

    Product
    NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2504-2025·2025-09-10

    Fluoroscopic X-ray systems recalled over air baffle missing from internal PCs

    Philips Allura Xper interventional fluoroscopic X-ray systems are recalled because an air baffle component may be missing in some Nehalem FlexVision-2 PCs. 192 units are affected.

    Product
    Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. All
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2518-2025·2025-09-10

    Hemodynamic recording systems recalled over pressure sensor error during blood pressure measurement

    Merge Hemo systems are recalled because certain Schiller ARGUS PB-3000 patient data modules trigger a Pressure Sensor Defective error during non-invasive blood pressure measurement above 240 mmHg. 84 units are affected.

    Product
    Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood fl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2516-2025·2025-09-10

    Spinal implant inserters recalled over potential missing pins at the tip

    TOPS Inserters, model 82889, part of the TOPS System Instrument Set, are recalled because of the potential for missing pins at the tip of the inserter. 30 units are affected.

    Product
    TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2497-2025·2025-09-10

    LIFEPAK 15 defibrillators recalled because post-service inspections were not performed

    Four LIFEPAK 15 defibrillators are recalled because required inspections were not performed on units that had gone through servicing.

    Product
    LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2489-2025·2025-09-10

    RayStation 9B and 10A software recalled over non-unique DICOM identifiers

    RayStation 9B, 9B SP1, 10A and 10A service pack radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software Version: 10.0.0.1154. 4. RayStation 10A Service Pack 1, Software Version: 10.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2487-2025·2025-09-10

    RayStation 7 and 8A software recalled over DICOM instance identifier defect

    RayStation 7, 8A and 8A Service Pack 1 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Version: 8.0.1.10. Product Description: Radiation Therapy Treatment Planning Sys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2500-2025·2025-09-10

    Uric acid meter kits recalled for distribution without premarket clearance

    Blood Uric Acid Monitoring System kits, model eB-U01, are recalled because the products were distributed without premarket clearance or approvals. 2,240 units are affected.

    Product
    Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2490-2025·2025-09-10

    RayStation 10B planning software recalled over DICOM identifiers not guaranteed unique

    RayStation 10B and 10B Service Pack 1 radiation therapy treatment planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2498-2025·2025-09-10

    LIFEPAK 1000 defibrillators recalled over inspections missed after unit servicing

    Three LIFEPAK 1000 defibrillators are recalled because required inspections were not performed on units that had gone through servicing.

    Product
    LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2493-2025·2025-09-10

    RayStation 12A planning software recalled over duplicate DICOM instance identifier risk

    RayStation 12A and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2501-2025·2025-09-10

    Uric acid monitoring kits recalled over missing premarket clearance or approval

    A second lot group of Blood Uric Acid Monitoring System kits, model eB-U01, covering all lots made up to June 20, 2022, is recalled for distribution without premarket clearance. 2,580 units are affected.

    Product
    Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2492-2025·2025-09-10

    RayStation 11B software recalled over non-unique DICOM instance identifiers

    RayStation 11B and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Soft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2488-2025·2025-09-10

    RayStation 8B and 9A software recalled over DICOM identifier uniqueness defect

    RayStation 8B, its service packs and 9A radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2499-2025·2025-09-10

    Defibrillator recalled because required post-service inspections were not performed

    One LIFEPAK CR2 defibrillator is recalled because required inspections were not performed on units that had gone through servicing.

    Product
    LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2491-2025·2025-09-10

    RayStation 11A planning software recalled over non-unique DICOM instance identifiers

    RayStation 11A and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3, Softw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2495-2025·2025-09-10

    RayStation 2023B and 2024A software recalled over non-unique DICOM identifiers

    RayStation 2023B, 2024A and 2024A SP3 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment Plannin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2517-2025·2025-09-10

    Flowmeter patches recalled over expiry date printed one year too early

    FloPatch FP120 flowmeter patches, lot 03250602, are recalled because the human readable expiry date on the outer shipping packaging reads 2025-06-20 when it should read 2026-06-20. 9 units are affected.

    Product
    FloPatch FP120, REF: FP120-FOT01-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2460-2025·2025-09-03

    Reprocessed electrophysiology catheters recalled over small residual particulates in specific lots

    Medline ReNewal reprocessed St. Jude Medical diagnostic electrophysiology catheters are recalled because specific lots may contain small residual particulates. The FDA classified the action as Class I.

    Product
    Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2343-2025·2025-09-03

    Insulin pumps recalled over malfunction that stops insulin delivery and alerts

    Tandem t:slim X2 insulin pumps built with Revision A and B speakers may hit Malfunction 16, losing audible alerts and stopping insulin delivery. The FDA classified the action as Class I. 171,750 units are affected.

    Product
    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2025·2025-09-03

    Loupe nose pad kits recalled because nickel content may cause allergic reaction

    Orascoptic Dragonfly Nose Pad Accessory Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 743 kits are affected.

    Product
    Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2445-2025·2025-09-03

    Phantom nose pad kits recalled because nickel content may cause allergic reaction

    Orascoptic Phantom Nose Pad Accessory Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 22 kits are affected.

    Product
    Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
    Category
    Medical Device
    Distribution
    Distributed nationwide