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.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

25101–25125 of 27686

  • HighFDA (Devices)·Z-1551-2014·2014-05-14

    GE Healthcare Recalls Nellcor SpO2 Upgrade Kits Due to Software Defect

    GE Healthcare is recalling 301 Nellcor SpO2 Upgrade kits because a software defect may cause false positive or false negative oxygen saturation and pulse rate alarms.

    Product
    Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1560-2014·2014-05-14

    Teleflex Medical Recalls Stainless Steel Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of Deknatel stainless steel sutures because the needle may detach from the suture during use.

    Product
    Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the…
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1528-2014·2014-05-14

    INOmax DSIR Nitric Oxide Delivery System Recalled for Monitoring Anomaly

    INO Therapeutics is recalling 22 INOmax DSIR Nitric Oxide Delivery Systems due to a software anomaly that may trigger unintended alarms.

    Product
    INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1568-2014·2014-05-14

    Medtronic Refill Kits Recalled Due to Occluded Extension Tubing Sets

    Medtronic is recalling specific Refill Kits for implantable infusion pumps because some contain occluded extension tubing that prevents filling. No patient injuries beyond additional needle sticks have been reported.

    Product
    Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1547-2014·2014-05-14

    GE Healthcare Recalls Giraffe Infant Warmers Due to Alarm Defect

    GE Healthcare is recalling 50 Giraffe Infant Warmers because a software defect may cause false oxygen saturation and pulse rate alarms.

    Product
    Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1513-2014·2014-05-07

    Brainlab ExacTrac 6.0 Radiation Positioning System Recalled for Targeting Error

    Brainlab AG is recalling ExacTrac 6.0 systems because they may position patients to unintended radiation targets, potentially delivering dose to the wrong location.

    Product
    ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET…
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1482-2014·2014-05-07

    Hospira Recalls Acclaim Infusion Pumps Due to Broken Door Assemblies

    Hospira is recalling 13,218 Abbott Acclaim Infusion Pumps because broken door assemblies may prevent the door from closing, potentially causing unrestricted flow or therapy delays.

    Product
    Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1483-2014·2014-05-07

    Hospira Acclaim Encore Infusion Pump Recall for Broken Door Assemblies

    Hospira is recalling 13,218 Acclaim Encore infusion pumps because broken door assemblies may prevent proper closure, causing unrestricted flow or therapy delays.

    Product
    Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1512-2014·2014-05-07

    Hospira Recalls GemStar Docking Stations Due to Power and Voltage Issues

    Hospira is recalling GemStar Docking Stations because they may cause infusion pumps to fail to power up or stop infusions due to voltage errors.

    Product
    GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1515-2014·2014-05-07

    Acumed Osteo-Clage System Recalled for Non-Specification Stainless Steel

    Acumed LLC is recalling the Osteo-Clage System because the stainless steel used in manufacturing was not within specifications.

    Product
    The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2014·2014-05-07

    GE Healthcare Recalls MRI Scanners Due to Cradle Release Malfunction

    GE Healthcare is recalling 1,548 MRI scanners because a malfunctioning cradle release mechanism could delay or impede patient egress from the system.

    Product
    GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1510-2014·2014-05-07

    Philips ADAC Nuclear Gamma Cameras Recalled for Potential Patient Contact

    Philips Medical Systems is recalling 1,043 ADAC nuclear gamma cameras because a belt slippage issue could cause the detector head to drift and contact patients.

    Product
    Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1511-2014·2014-05-07

    GE Healthcare Recalls CardiacVX Software Due to Inaccurate Flow Values

    GE Healthcare is recalling CardiacVX and CardiacVX Flow software because it may report flow values higher than actual. The recall affects 101 units distributed worldwide.

    Product
    GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1521-2014·2014-05-07

    Fisher Scientific Recalls Sterile Swabs Due to Organism Contamination

    Fisher Scientific is recalling Fisherbrand Sterile Swabs after a customer reported the presence of an organism in a lot of wood applicator swabs.

    Product
    Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2014·2014-05-07

    Acumed Recalls Tension Band Pins Due to Steel Specification Defect

    Acumed LLC is recalling specific lots of Tension Band Pins because they were manufactured with stainless steel that does not meet specifications.

    Product
    The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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