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 the agency’s own highest classification or reported deaths or serious injuries, 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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39826–39850 of 40480

  • ModerateFDA (Devices)·Z-2467-2012·2012-10-03

    K-Y Liquibeads Vaginal Moisturizer Recalled for Regulatory Compliance

    Johnson & Johnson is voluntarily recalling K-Y Liquibeads Vaginal Moisturizer to address FDA concerns regarding the product's medical device clearance status.

    Product
    KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2441-2012·2012-10-03

    Cordis Recalls Sleek OTW PTA Catheters Due to Incorrect Labeling

    Cordis Corporation is recalling specific lots of Sleek OTW PTA Dilatation Catheters because they are incorrectly labeled.

    Product
    Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No.…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2448-2012·2012-10-03

    Applied Medical Recalls Irrigation Catheters Due to Packaging Particulate Matter

    Applied Medical Resources Corp is recalling specific lots of irrigation catheters because packaging particulate matter may reside on the product.

    Product
    Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2460-2012·2012-10-03

    Alere Triage TOX Drug Screen 9 Panel Recalled for Meter Calibration Issues

    Alere San Diego is recalling 591 kits of the Alere Triage TOX Drug Screen 9 Panel because code chips may not set threshold ranges correctly in meters.

    Product
    Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2471-2012·2012-10-03

    Ev3 Neurovascular Recalls Mislabeled UltraFlow Micro Catheters

    Ev3 Neurovascular is recalling 36 UltraFlow HPC Flow Directed Micro Catheters because one lot may have been mislabeled.

    Product
    UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2444-2012·2012-10-03

    RaySearch SharePlan Software Recalled for Unexpected Import Behavior

    RaySearch Laboratories is recalling SharePlan 1.1 software due to unexpected behavior when importing specific files. The issue has not caused patient mistreatment.

    Product
    SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment…
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-2445-2012·2012-10-03

    Trinity Biotech Captia VZV IgG Kits Recalled for Positive Control Issues

    Clark Laboratories is recalling 810 Captia VZV IgG kits because the positive control ran high out of its assigned range.

    Product
    Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2454-2012·2012-10-03

    Neomend Recalls Progel Pleural Air Leak Sealant Due to Incorrect Expiration Date

    Neomend Inc is recalling 95 units of Progel Pleural Air Leak Sealant because the product was labeled with an incorrect expiration date.

    Product
    Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2352-2012·2012-09-26

    Custom Vein Tray Recalled for Povidone Iodine Prep Solution Quality Issues

    Custom Medical Specialties is recalling CMS-8450-R1 Custom Vein Trays because the included Povidone Iodine Prep Solution lacked microbial testing and failed finished goods specifications.

    Product
    CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2359-2012·2012-09-26

    Custom Medical Specialties Recalls Myelogram Trays with PVP Prep Solution

    Custom Medical Specialties is recalling CMS-5284 Custom Myelogram Trays containing PVP Prep Solution because the solution lacked microbial testing and failed to meet finished goods specifications.

    Product
    CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2351-2012·2012-09-26

    Custom Vein Tray Recalled for Missing Microbial Testing

    Custom Medical Specialties is recalling CMS-4316 Custom Vein Trays because the included PVP Prep Solution lacked required microbial testing.

    Product
    CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2349-2012·2012-09-26

    Custom Medical Specialties Recalls HSG Trays with Povidone Iodine Prep Solution

    Custom Medical Specialties is recalling CMS-4501-R1 Custom HSG Trays because the included Povidone Iodine Prep Solution lacked microbial testing and failed finished goods specifications.

    Product
    CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2358-2012·2012-09-26

    Custom Medical Specialties Recalls HSG Trays with PVP Prep Solution

    Custom Medical Specialties is recalling CMS-4975 HSG Trays containing PVP Prep Solution because the product lacked microbial testing and did not meet specifications.

    Product
    CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2356-2012·2012-09-26

    Custom Vein Tray Recalled for Unverified Povidone Iodine Solution

    Custom Medical Specialties is recalling Custom Vein Trays containing Povidone Iodine Prep Solution because the product lacked required microbial testing and failed specifications.

    Product
    CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2395-2012·2012-09-26

    Hospira Recalls Empty Evacuated Containers Due to Embedded Iron Oxide Glass Defect

    Hospira Inc. is recalling 191,094 units of Empty Evacuated Containers (250 mL and 1000 mL) because an embedded iron oxide glass defect may break off into the solution.

    Product
    Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2355-2012·2012-09-26

    Custom Medical Specialties Recalls Radiology Drainage Packs with PVP Prep Solution

    Custom Medical Specialties is recalling Abington Radiology Drainage Packs containing PVP Prep Solution because the solution lacked microbial testing and did not meet finished goods specifications.

    Product
    CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2360-2012·2012-09-26

    Custom Medical Specialties Recalls Hysteroscopy Kits Due to Microbial Testing Failures

    Custom Medical Specialties is recalling BR980-9600 Hysteroscopy Sterile Procedure Kits because the included Povidone Iodine Prep Solution lacked required microbial testing and failed finished goods specifications.

    Product
    BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2353-2012·2012-09-26

    Custom Medical Specialties Recalls Amnio Trays with PVP Prep Solution

    Custom Medical Specialties is recalling CMS-2586 Custom Amnio Trays containing PVP Prep Solution because the product lacked microbial testing and did not meet finished goods specifications.

    Product
    CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2357-2012·2012-09-26

    Custom Medical Specialties Recalls CT Biopsy Trays with PVP Prep Solution

    Custom Medical Specialties is recalling CT biopsy trays containing PVP Prep Solution because the solution lacked microbial testing and did not meet specifications.

    Product
    CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2354-2012·2012-09-26

    Custom Medical Specialties Recalls PVP Prep Solution Due to Microbial Testing Failures

    Custom Medical Specialties is recalling 75 cases of CMS-8162-R1 Fox Chase Specials Packs containing PVP Prep Solution because the product did not meet finished goods specifications and lacked microbial testing.

    Product
    CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2350-2012·2012-09-26

    Hysteroscopic Sterilization Pack Recalled for Missing Microbial Testing

    Custom Medical Specialties is recalling Hysteroscopic Sterilization Packs because the included Povidone Iodine Prep Solution lacked required microbial testing.

    Product
    CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2390-2012·2012-09-26

    Instrumentation Laboratory ACL TOP 700 LAS Analyzer Recalled for Fibrinogen Errors

    Instrumentation Laboratory is recalling ACL TOP 700 LAS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.

    Product
    Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2421-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling REXEED hemodialyzers after identifying a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2423-2012·2012-09-26

    Asahi Kasei Recalls REXEED 15 LX Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 24 units of REXEED 15 LX hemodialyzers due to a negative trend in adverse events potentially linked to manufacturing changes.

    Product
    Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2384-2012·2012-09-26

    Philips DigitalDiagnost Systems Recalled for Electrical Safety Standard Non-Compliance

    Philips Healthcare Inc. is recalling four DigitalDiagnost Systems because the GEO Transformer does not meet international electrical safety standards.

    Product
    Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
    Category
    Medical Device
    Distribution
    2 states