The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1526–1550 of 21588

  • 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-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-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-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-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-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-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-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-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-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 (Drugs)·D-0618-2025·2025-09-10

    Chlorpromazine 100 mg tablets recalled over micro-organism on packaging coil

    Amneal chlorpromazine hydrochloride tablets, 100 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2025·2025-09-10

    Chlorpromazine 50 mg tablets recalled over micro-organism on packaging coil

    Amneal chlorpromazine hydrochloride tablets, 50 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    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-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-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-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 (Drugs)·D-0615-2025·2025-09-10

    Sulfamethoxazole and trimethoprim tablets recalled over micro-organism on packaging coil

    Amneal sulfamethoxazole and trimethoprim double strength tablets are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    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
  • 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-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-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-2474-2025·2025-09-03

    Anti-Xa 4 test kits recalled over potential fibrinogen reagent contamination

    STA-Liquid Anti-Xa 4 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 116,600 units are affected.

    Product
    STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0525-2025·2025-09-03

    Hummus recalled because labels omit keep refrigerated storage instructions

    Gelson's Hummus, 8 oz, sold in the firm's Southern California grocery stores, is recalled because the label does not carry the storage instruction to keep refrigerated.

    Product
    Gelson's Hummus; Mediterranean Old World Family Recipe California-Made No Added Oils NET WT 8OZ (226g) UPC: 23631-10261
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2419-2025·2025-09-03

    Light therapy devices recalled over welded nut that may shear off

    Two NovoTHOR Gen 3.0 Reg PRX units are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.

    Product
    Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
    Category
    Medical Device
    Distribution
    Distributed nationwide