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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27301–27325 of 27722

  • 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 (Drugs)·D-1674-2012·2012-09-26

    Carefusion Recalls ChloraPrep Applicators Due to Incomplete Seals

    Carefusion is recalling 67,775 ChloraPrep with Tint applicators because some units had incomplete seals, potentially compromising sterility.

    Product
    ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
    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
  • HighFDA (Devices)·Z-2378-2012·2012-09-26

    RaySearch TomoTherapy SharePlan Software Field Notice for Unexpected Behaviors

    RaySearch Laboratories issued a field notice for TomoTherapy SharePlan software due to two unexpected behaviors not clearly described in the user manual. No patient mistreatment or incidents have occurred.

    Product
    The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Drugs)·D-1676-2012·2012-09-26

    Dukal BZK Swabs Recalled for Burkholderia cepacia Contamination

    Dukal Corporation is recalling BZK Swabs, First Aid Antiseptic, due to microbial contamination with Burkholderia cepacia. The recall covers specific lots shipped since July 2009.

    Product
    Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swabs per box. Packaging labeled with Dukal Corporation, Hauppauge, NY 11788…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2402-2012·2012-09-26

    Steris Surgical Table Recalled for Potential Unintended Movement

    Steris Corporation is recalling 11,044 surgical tables because prohibited storage of objects on the base or column can damage the override switch, potentially causing the table to move without operator prompting.

    Product
    A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2429-2012·2012-09-26

    Integra HRAIM Head Ring Assembly Recalled for T-Handle Seating Issue

    Integra LifeSciences is recalling HRAIM Head Ring Assemblies because a T-handle screw may prevent the CRW stereotactic system from seating properly.

    Product
    Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2403-2012·2012-09-26

    Roche Amplilink Software Recall Due to Potential Wrong Test Results

    Roche Molecular Systems is recalling Amplilink Software 3.2.3 because it may assign wrong results to orders when used with certain Laboratory Information Systems.

    Product
    Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2389-2012·2012-09-26

    Instrumentation Laboratory ACL TOP Analyzer Recalled for Fibrinogen Reporting Errors

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

    Product
    Instrumentation Laboratory ACL TOP CTS PN 0000280020 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-2382-2012·2012-09-26

    Spacelabs Ultraview SL Integrated Module Housing Recalled for Potential Failure

    Spacelabs Healthcare is recalling Ultraview SL Integrated Module Housings because they may fail, causing patient module parameters to drop off the monitor display or preventing modules from signing on.

    Product
    Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm…
    Category
    Medical Device
    Distribution
    0 states