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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39851–39875 of 40356

  • ModerateFDA (Devices)·Z-2323-2012·2012-09-12

    Trek Diagnostic Systems Recalls VersaTREK Windows Software Version 5.4.3

    Trek Diagnostic Systems is recalling VersaTREK Windows Software Version 5.4.3 because positive test results may incorrectly revert to negative in the database.

    Product
    VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms…
    Category
    Medical Device
    Distribution
    38 states
  • LowFDA (Devices)·Z-2325-2012·2012-09-12

    Steris recalls 77 packs of medical tubing due to failed process indicators

    Steris Corporation is recalling 77 packs of medical tubing that failed process indicators. The tubing is used to maintain the sterility of enclosed medical devices.

    Product
    100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2314-2012·2012-09-12

    Quality Electrodynamics Recalls 17 Non-Functional MRI Knee Coils

    Quality Electrodynamics LLC is recalling 17 TxRx Knee 15 Coil 3T units because the coil identification code is incorrect, rendering the devices non-functional.

    Product
    TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2281-2012·2012-09-05

    Advanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Systems

    Advanced Neuromodulation Systems is recalling Eon Mini Neurostimulation Systems due to reports of warmth or heating at the implant site during charging.

    Product
    The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2274-2012·2012-09-05

    Atlas Spine Recalls Apelo Modular Screwdriver Due to Tip Breakage

    Atlas Spine, Inc. is recalling the Apelo Modular Screwdriver because the tip may break and become implanted in the body or delay surgery.

    Product
    Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2253-2012·2012-09-05

    I-Flow Recalls ON-Q Pumps Due to Bolus Button Malfunction

    I-Flow Corporation is recalling ON-Q pumps with ONDEMAND because the bolus button may fail to lock, causing patients to receive medication at higher-than-expected rates.

    Product
    ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2301-2012·2012-09-05

    Recall of DGHP RFA High-Power Grounding Pads Due to Burn Risk

    Nellcor Puritan Bennett Inc. is recalling DGHP RFA High-Power grounding pads and electrode kits because foil degradation may cause electrical burns to patients.

    Product
    DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2280-2012·2012-09-05

    Advanced Neuromodulation Systems Recalls Eon IPG for Heating Complaints

    Advanced Neuromodulation Systems is recalling Eon IPGs due to reports of warmth or heating at the implant site during charging.

    Product
    Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2251-2012·2012-09-05

    GE OEC Surgical Navigation Systems Recalled for Unvalidated Headset Configuration

    GE OEC Medical Systems is recalling 768 surgical navigation systems because the Inverted Headset Placement is not a validated configuration.

    Product
    OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2266-2012·2012-09-05

    Toshiba CT Systems Recalled for Potential Table Position Errors

    Toshiba American Medical Systems is recalling 757 CT systems because a table control board defect may cause patients to be scanned at incorrect positions.

    Product
    Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2303-2012·2012-09-05

    Philips SureSigns VSi and VS2+ Patient Monitors Recalled for Mounting Defect

    Philips is recalling SureSigns VSi and VS2+ patient monitors because they may not be properly secured to wall mounts and could fall.

    Product
    Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2296-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units were distributed nationwide in the US.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2012·2012-09-05

    Medline Electrosurgical Electrodes Recalled for Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units are intended for cutting and coagulation of soft tissue.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2012·2012-09-05

    Medline PTFE Coated Needle Recall Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline Standard PTFE Coated Needles due to sterility concerns. The affected lots are distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2304-2012·2012-09-05

    Sendx Medical Recalls ABL80 FLEX Blood Gas Analyzers for Glucose Errors

    Sendx Medical Inc is recalling ABL80 FLEX and ABL80 FLEX CO-OX analyzers because glucose measurements may be inaccurate and not reflect patient clinical conditions.

    Product
    ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units are intended for cutting and coagulation of soft tissue.

    Product
    Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to concerns regarding sterility. The affected products are intended for cutting and coagulation of soft tissue.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2267-2012·2012-09-05

    Metrex Recalls CaviCide Disinfectant Due to Reported Health Reactions

    Metrex Research is recalling CaviCide disinfectant with Spring Fresh Fragrance because it caused health reactions like headaches and nausea in some users.

    Product
    CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part numbers: 13-7400 and 13-7405. pdCARE Surface…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Needles Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical needles due to concerns about sterility. The affected lot is distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling specific lots of Medline electrosurgical electrodes due to concerns regarding sterility.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2012·2012-09-05

    Cisco HealthPresence Software Recall for Vital Signs Display Errors

    Cisco Systems is recalling HealthPresence software version 2.1 because subsequent vital signs readings may not update correctly in the OnePlace tab, potentially leading to incorrect interpretations.

    Product
    Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2286-2012·2012-09-05

    Medline Extended PTFE Needle Recall for Sterility Concerns

    Unimed Surgical Products is recalling Medline Extended PTFE Needles due to sterility concerns. The recall affects 1,440 units distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2012·2012-09-05

    Canon Solid State X-ray Imager Recall Due to Loose Screws

    Canon is recalling 468 Solid State X-ray Imagers because screws holding the 55REF circuit board are loosening and roaming inside the sealed sensor.

    Product
    Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to concerns about sterility. The recall affects 1,920 units distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of…
    Category
    Medical Device
    Distribution
    Distributed nationwide