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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35926–35950 of 40449

  • ModerateFDA (Devices)·Z-1525-2014·2014-05-07

    Medtronic Activa Neurostimulators Recalled for Cycling Feature Labeling

    Medtronic is recalling Activa neurostimulators because current labeling indicates the cycling feature improves device longevity and recharge interval.

    Product
    Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for movement disorders.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1522-2014·2014-05-07

    Integra CUSA Excel Disposable Wrench Recalled for Incorrect Assembly

    Integra LifeSciences is recalling CUSA Excel Disposable Wrenches because some units were incorrectly assembled with the wrong hex wrench insert.

    Product
    Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1524-2014·2014-05-07

    Medtronic Neurostimulators Recalled for Cycling Feature Labeling Concerns

    Medtronic is recalling specific neurostimulators because current labeling indicates the cycling feature improves device longevity, a claim that may be inaccurate.

    Product
    Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1514-2014·2014-05-07

    Elekta Recalls HexaPOD evo RT Couchtop Units Due to Loose Screw Risk

    Elekta is recalling 266 HexaPOD evo RT Couchtop units because screws may become loose if not properly tightened with a torque wrench.

    Product
    HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.
    Category
    Medical Device
    Distribution
    29 states
  • CriticalFDA (Devices)·Z-1471-2014·2014-04-30

    Heartware HVAD Pump Implant Kit Recalled for Driveline Connector Separation

    HeartWare Inc is recalling HVAD Pump Implant Kits because the driveline connector housing may separate. This defect could affect patients using the device for heart failure.

    Product
    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1481-2014·2014-04-30

    RaySearch Ray Station Software Recalled for Dose Miscalculations

    RaySearch Laboratories is recalling Ray Station software versions 2.0 through 4.0 due to dose miscalculations for support structures on CT images.

    Product
    RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1492-2014·2014-04-30

    Ion Beam Applications Recalls Proteus 235 Proton Therapy System Software

    Ion Beam Applications is recalling Proteus 235 Proton Therapy System Legacy Software due to incorrect dose rate calculations for non-zero beam line options.

    Product
    Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1480-2014·2014-04-30

    GE Healthcare Recalls MR Scanners Due to Gradient Coil Overheating Risk

    GE Healthcare is recalling 1,546 MRI scanners worldwide because gradient coil connections may loosen, causing overheating, smoke, and potential fire.

    Product
    GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1484-2014·2014-04-30

    Baxter Recalls Sigma Spectrum Volumetric Infusion Pumps Due to System Errors

    Baxter Healthcare is recalling Sigma Spectrum Volumetric Infusion Pumps due to repeated System Error 322 occurrences.

    Product
    SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2014·2014-04-30

    Philips Digital Diagnost Radiographic System Recall Due to Footboard Defect

    Philips is recalling 985 Digital Diagnost stationary radiographic systems because the footboard may not be securely held if the fix clamp is not correctly adjusted.

    Product
    Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1493-2014·2014-04-30

    Stryker PenAdapt Electrosurgical Accessory Recalled for Sterile Barrier Breach

    Stryker is recalling 35,310 PenAdapt electrosurgical accessories due to packaging cuts that may breach the sterile barrier and the presence of aluminum shavings.

    Product
    Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1509-2014·2014-04-30

    Teleflex Recalls Monodek Violet Synthetic Absorbable Surgical Sutures

    Teleflex Medical is recalling Monodek Violet Synthetic Absorbable Surgical Sutures because they do not meet minimum knot tensile strength requirements.

    Product
    Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1476-2014·2014-04-30

    BioMerieux Recalls FB Reagent Due to False Negative Test Results

    BioMerieux SA is recalling FB Reagent (REF 70562) and ZYM B reagent (REF 70493) because a visual defect and activity issue can cause false negative results in Rapid ID 32 and API biochemical tests.

    Product
    FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1474-2014·2014-04-30

    Remel Recalls Oxoid Legionella Pneumo Groups 2-14 Test Kits

    Remel Inc is recalling two boxes of Oxoid Legionella Pneumo Groups 2-14 test kits because a reagent may produce false negative results.

    Product
    Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1495-2014·2014-04-30

    Philips MDC PACS and IntelliSpace PACS DCX Software Recall for Density Errors

    Philips is recalling MDC PACS and IntelliSpace PACS DCX software because it may display incorrect density measurements on Enhanced CT and MR examinations.

    Product
    Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1473-2014·2014-04-30

    Remel Recalls Oxoid Legionella Latex Test Due to False Negative Risk

    Remel Inc is recalling specific lots of Oxoid Legionella Latex Test kits because a reagent may produce false negative results.

    Product
    Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1488-2014·2014-04-30

    GE Vivid E9 Ultrasound System Recalled for Probe Overheating Risk

    GE Healthcare is recalling Vivid E9 Ultrasound Systems because incorrect power settings for four specific probe types may cause them to overheat.

    Product
    GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1506-2014·2014-04-30

    Teleflex Recalls Sengstaken Tubes Due to Sterility Concerns

    Teleflex Medical is recalling Sengstaken and Sengstaken-Blakemore tubes because the sterility of the product cannot be guaranteed.

    Product
    Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2014·2014-04-30

    BioMerieux Recalls ZYM B and FB Reagents Due to False Negative Results

    BioMerieux is recalling ZYM B and FB reagents because a visual defect and activity issue caused false negative results in Rapid ID 32 strips and API biochemical tests.

    Product
    API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1472-2014·2014-04-30

    Pega Medical Recalls Fassier-Duval IM Telescopic System Due to Labeling Error

    Pega Medical Inc. is recalling 48 units of the Fassier-Duval IM Telescopic System because the outer package label listed the incorrect device length.

    Product
    Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1500-2014·2014-04-30

    Meta Labs Recalls Nice-En-Smooth Berry Burst Lubricant for Unregistered Manufacturing

    Altasource LLC dba Meta Labs LLC is recalling Nice-En-Smooth Berry Burst lubricant because the firm is not registered as a drug manufacturer.

    Product
    Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1507-2014·2014-04-30

    Arrow Recalls Antimicrobial Central Venous Catheters Due to Labeling Error

    Arrow International is recalling 170 units of Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheters because the lidstock incorrectly lists the catheter length as 16CM instead of 20CM.

    Product
    Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1489-2014·2014-04-30

    Ev3 Recalls EverCross PTA Dilatation Catheters Due to Labeling Error

    Ev3 is recalling two lots of EverCross PTA Dilatation Catheters because of a discrepancy in the balloon and delivery catheter lengths printed on the product labeling.

    Product
    ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1479-2014·2014-04-30

    Hospira Recalls HemoSet IV Sets Due to Incorrect Lower Lid Component

    Hospira is recalling 3,893 HemoSet IV sets because an incorrect lower lid was used during manufacturing, which changes the drop rate from 15 to 10 drops per mL.

    Product
    LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Infusers.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1486-2014·2014-04-30

    Merit Medical Recalls Hydrophilic Guide Wires Due to Labeling Discrepancy

    Merit Medical Systems is voluntarily recalling specific lots of Laureate Hydrophilic Guide Wires due to a discrepancy between carton and unit labeling.

    Product
    Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
    Category
    Medical Device
    Distribution
    Distributed nationwide