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

35726–35750 of 40449

ModerateFDA (Devices)·Z-1741-2014·2014-06-18
Ortho-Clinical enGen Laboratory Automation System Software Recall
Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems configured with TCAutomation Software v3.5 due to potential buffer timeout issues.
Product
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in…
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1778-2014·2014-06-18
Stryker Precision Neuro Drill Recall Due to Missing Notches
Stryker is recalling 6,481 Precision Neuro Drills because some cutting accessories may have missing or partial notches, which could affect their use with Elite Attachments.
Product
Stryker 3.0mm x 3.8mm Precision Neuro Drill 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
ModerateFDA (Devices)·Z-1761-2014·2014-06-18
Stryker Elite Bur Recall Due to Missing Notches
Stryker is recalling 2.0mm Tapered Round Elite Burs because some units have missing or partial notches. The devices are used for cutting bone during surgery.
Product
Stryker 2.0mm Tapered Round Elite Bur 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
ModerateFDA (Devices)·Z-1738-2014·2014-06-18
Ortho-Clinical enGen Laboratory Automation Systems Recalled for Software Anomaly
Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems with specific TCAutomation software versions due to a potential delay in reporting patient sample test results.
Product
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. --- Background: The enGen Lab Automation System is a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1749-2014·2014-06-18
Stryker 0.5mm Round Fluted Bur Recalled for Missing Notches
Stryker is recalling 27 sterile 0.5mm Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.
Product
Stryker 0.5mm Round Fluted Bur 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 applications…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1779-2014·2014-06-18
Stryker 5.0mm Barrel Bur Recall for Missing Notches
Stryker is recalling 5.0mm Barrel Bur devices because some units have missing or partial notches, which may affect their use with Elite Attachments.
Product
Stryker 5.0mm Barrel Bur 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 applications…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1737-2014·2014-06-18
Beckman Coulter Recalls Ultrasonic Transducer Kits Due to Incorrect Screws
Beckman Coulter is recalling 82 Ultrasonic Transducer Kits because they may have been assembled with incorrect mounting screws.
Product
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1780-2014·2014-06-18
Stryker Neuro Drill Accessories Recalled for Missing Notches
Stryker is recalling 916 sterile neuro drill cutting accessories due to missing or partial notches that may affect device performance.
Product
Stryker 3.0mm x 3.8mm Neuro Drill Less 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1732-2014·2014-06-18
Teleflex Recalls RUSCH Easy Cath Coude Kits Due to Incorrect Catheter Type
Teleflex Medical is recalling 1,000 RUSCH Easy Cath Coude Kits because they were packaged with straight catheters instead of the required curved ones.
Product
RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1757-2014·2014-06-18
Stryker 4.5mm Round Fluted Bur Recall for Missing Notches
Stryker is recalling 62 units of 4.5mm Round Fluted Bur Aggressive Sterile devices due to missing or partial notches.
Product
Stryker 4.5mm 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
ModerateFDA (Devices)·Z-1763-2014·2014-06-18
Stryker Recalls Four Zyphr Elite Round Fluted Bur Units
Stryker is recalling four sterile Zyphr Elite Round Fluted Bur units due to missing or partial notches that may affect compatibility with Elite attachments.
Product
Stryker 5.0mm Zyphr Elite Round Fluted Bur 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
ModerateFDA (Devices)·Z-1773-2014·2014-06-18
Stryker Wire Pass Drill Recalled for Missing Notches
Stryker is recalling 246 sterile 1.5mm Wire Pass Drills because some units may have missing or partial notches, which could affect their use with Elite Attachments.
Product
Stryker 1.5mm Wire Pass Drill 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 applications…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1766-2014·2014-06-18
Stryker 5.0mm Egg Bur Recall Due to Missing Notches
Stryker is recalling 144 units of 5.0mm Egg Bur sterile devices because some cutting accessories may have missing or partial notches.
Product
Stryker 5.0mm Egg Bur 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 applications including…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1731-2014·2014-06-18
Summit Medical Recalls Mixed Lot of Armstrong Grommet Ventilation Tubes
Summit Medical, Inc. is recalling one lot of Armstrong Grommet ventilation tubes due to mixed flange types. The agency states this poses no health hazard to users or patients.
Product
Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-1787-2014·2014-06-18
Beekley Spots Light Image O-Spots Recalled for Mislabeled Dispenser
Beekley Corporation is recalling 81 boxes of Light Image O-Spots for mammography because the dispensers were mislabeled as S-Spots.
Product
Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography
Category
Medical Device
Distribution
6 states
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
SevereFDA (Devices)·Z-1706-2014·2014-06-11
GE Healthcare Recalls Kenex Ceiling Suspended Radiation Shields and Lamps
GE Healthcare is recalling Kenex ceiling suspended radiation shields and surgical lamps due to improper installation. A reported incident involved a shield falling from the ceiling.
Product
Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1719-2014·2014-06-11
ConMed Recalls MACROLYTE Premie Dispersive Electrodes Due to Sparking and Burning
ConMed Corporation is recalling MACROLYTE Premie Dispersive Electrodes due to confirmed complaints of sparking, no output, and burning at the cord set connection.
Product
MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1714-2014·2014-06-11
Toshiba Infinix X-Ray System Recalled for Table Movement Safety Issue
Toshiba is recalling two Infinix X-Ray Interventional Systems because the table may continue moving during longitudinal tilt despite error signals.
Product
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1718-2014·2014-06-11
Intuitive Surgical da Vinci Patient Side Cart Recall for Torque Wrench Calibration
Intuitive Surgical is recalling two da Vinci Patient Side Cart assemblies because torque wrenches used to tighten bolts were out of calibration, potentially causing system faults or mechanical issues.
Product
Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1712-2014·2014-06-11
Microport Recalls PATH Thread Cup Adaptors Due to Removal Difficulty
Microport Orthopedics is recalling 140 units of PATH Thread Cup Adaptors because they may be difficult to remove from the impaction handle during surgery.
Product
PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1700-2014·2014-06-11
Hologic Selenia Mammography System Recalled for Defective Emergency Off Switch
Hologic is recalling 11 Selenia Full Field Digital Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.
Product
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1721-2014·2014-06-11
Siemens CT Systems Recalled Due to Rubber Damper Degradation Risk
Siemens Medical Solutions is recalling 345 CT systems because a rubber damper may degrade and break, potentially causing motor mounting plates to loosen and injuring operators or patients.
Product
Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1716-2014·2014-06-11
Stryker NAV3i Platform Power Box Recalled for Missing Electrical Insulation
Stryker is recalling 20 NAV3i Platform Power Boxes that may lack electrical insulation on soldering joints, posing a risk of electric shock.
Product
The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1699-2014·2014-06-11
Cochlear Baha Soft Tissue Gauge Recalled for Metal Surface Imperfections
Cochlear Americas Inc. is recalling 288 Baha Soft Tissue Gauges due to manufacturing imperfections that could leave residual metal on patient skin.
Product
Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.
Category
Medical Device
Distribution
Distributed nationwide

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35726–35750 of 40449