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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

25026–25050 of 27722

HighFDA (Devices)·Z-1826-2014·2014-06-25
Philips Ingenia FlexTrak Trolley Recalled for Foot Clamping Hazard
Philips is recalling Ingenia HA FLEX TRAK Trolleys because the central column can clamp a patient's foot. The recall covers 420 units distributed worldwide.
Product
Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1824-2014·2014-06-25
Spacelabs Ventilator Interface Recalled for Minute Volume Display Error
Spacelabs Healthcare is voluntarily recalling Ventilator Flexport Interfaces because the bedside monitor may display minute volume values up to ten times the actual value.
Product
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1839-2014·2014-06-25
ConMed Recalls Altrus Thermal Tissue Fusion Handpieces Due to Burn Risk
ConMed Corporation is recalling Altrus Thermal Tissue Fusion Handpieces due to a risk of burns. The recall covers 12,653 units distributed worldwide.
Product
Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1808-2014·2014-06-25
GE Healthcare Compact Airway Modules Recalled for Pump Failure Risk
GE Healthcare is recalling Compact Airway Modules because a loose screw may cause pump failure, leading to loss of respiratory gas monitoring.
Product
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1811-2014·2014-06-25
Biomet Spine Cypher MIS Screw Inserter Recalled for Tip Failure
Ebi, LLC is recalling 32 units of the Biomet Spine Cypher MIS Screw Inserter due to an increased rate of instrument tip failure.
Product
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1825-2014·2014-06-25
Ability Dynamics Recalls RUSH81 Prosthetic Feet Due to Bolt Failure Risk
Ability Dynamics is recalling 175 RUSH81 prosthetic feet because existing bolts may be bottomed out in threaded holes, which could lead to bolt failure.
Product
RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1641-2014·2014-06-18
Smiths Medical Recalls Mislabelled Portex Low Dead Space Connectors
Smiths Medical ASD, Inc. is recalling one lot of Portex Low Dead Space Connectors with Sideport because 3.0mm devices were packaged and labeled as 3.5mm.
Product
Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1784-2014·2014-06-18
Cordis EMPIRA RX PTCA Dilatation Catheter Recalled for Potential Bursting
Cordis Corporation is recalling 80 units of EMPIRA RX PTCA Dilatation Catheters because they may exhibit radial versus axial tears if they burst during inflation.
Product
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1733-2014·2014-06-18
Siemens Vista Air Compressor Recalled for Fire and Shock Hazards
Siemens Healthcare Diagnostics is recalling four Vista Air Compressors because miswiring could cause a fire or electrical shock if powered up.
Product
Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems. Siemens Healthcare Diagnostics Dimension Vista System is an in vitro…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1756-2014·2014-06-18
Stryker 3.0mm Round Fluted Bur Recalled for Missing Notches
Stryker is recalling 285 sterile 3.0mm Round Fluted Bur Aggressive devices due to missing or partial notches. The defect may affect the device's compatibility with Elite Attachments.
Product
Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1747-2014·2014-06-18
Neo Metrics Recalls NovaGold Guidewires Due to Tip Uncoiling Risk
Neo Metrics, Inc. is recalling NovaGold High Performance Guidewires because the tip may uncoil or detach more frequently than anticipated. No illnesses or injuries have been reported.
Product
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1727-2014·2014-06-18
Alere Triage D-Dimer Test Recalled for Incorrect Manufacturing
Alere San Diego, Inc. is recalling 373 kits of the Alere Triage D-Dimer Test (Lot W53884B) because they may generate error codes or incorrect results.
Product
Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage¿ Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1746-2014·2014-06-18
Philips IntelliVue MX40 Wearable Patient Monitor Alarm Failure Recall
Philips is recalling IntelliVue MX40 monitors because alarms may not resume after being paused, potentially delaying clinical response.
Product
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1744-2014·2014-06-18
BioDerm Skin Wipes Recalled for Potential Bacterial Contamination
BioDerm, Inc. is voluntarily recalling specific skin wipes used in male incontinence devices due to potential bacterial contamination from a contract manufacturer.
Product
BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1786-2014·2014-06-18
Teleflex Recalls Taut Operative Cholangiogram Catheters Due to Missing Metal Support Tube
Teleflex Medical is recalling 450 Taut Operative Cholangiogram Catheters because the metal support tube is missing. The recall covers units distributed in the US and Belgium.
Product
Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy.
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1742-2014·2014-06-18
BioDerm Skin Wipes Recalled for Potential Bacterial Contamination
BioDerm, Inc. is voluntarily recalling skin-prep wipes used with external male catheters due to potential bacterial contamination.
Product
BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1740-2014·2014-06-18
Ivoclar Vivadent Recalls Bluephase Style Light Probes Due to Broken Glass Fibers
Ivoclar Vivadent is recalling 241 Bluephase style light probes because a stock check revealed broken glass fibers between the connector and the fiber bundle.
Product
bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1730-2014·2014-06-18
Maquet PowerLED 700 Surgical Light Recall Due to Detaching Module
Maquet is recalling PowerLED 700 surgical lights because plastic tabs may break, causing the ambient light module to partially detach.
Product
Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1734-2014·2014-06-18
Ortho-Clinical VITROS 4600 Chemistry System Recalled for Biased Results
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems due to a potential for biased results when using Multiple Window codes.
Product
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1725-2014·2014-06-18
Leica Ceiling Mount MSF-1 Recalled Due to Broken Drive Screw
Leica Microsystems is recalling 103 MSF-1 ceiling mounts because a broken drive screw caused the lift arm to fall approximately 60 cm.
Product
Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V. Intended to be used for improving the visibility of objects through…
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1726-2014·2014-06-18
Leica Ceiling Mounts Recalled Due to Broken Drive Screw
Leica Microsystems is recalling 103 ceiling mounts for M500 N microscopes because a broken drive screw caused the lift arm to fall approximately 60 cm.
Product
Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446658 utilizes a supply voltage of 220 V. Intended to be used for improving the visibility of objects through…
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1782-2014·2014-06-18
Cooper Surgical Tampa Catheter Recalled for Potential Sterility Compromise
CooperSurgical is recalling 1,180 units of the Tampa Catheter because unsealed pouches may compromise the device's sterility.
Product
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1743-2014·2014-06-18
BioDerm Skin Wipes Recalled for Potential Bacterial Contamination
BioDerm, Inc. is voluntarily recalling skin-prep wipes used with external male catheters due to potential bacterial contamination.
Product
BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1783-2014·2014-06-18
Philips IntellVue Info Center Patient Monitor Recall for Reboot Loop
Philips is recalling IntellVue Info Center monitors because a software defect causes reboot loops that interrupt patient monitoring.
Product
Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1715-2014·2014-06-11
Stryker NAV3i Platform Power Boxes Recalled for Missing Electrical Insulation
Stryker is recalling 20 NAV3i Platform Power Boxes because they may lack electrical insulation on soldering joints, posing a shock hazard.
Product
The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical…
Category
Medical Device
Distribution
10 states

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25026–25050 of 27722