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

25301–25325 of 27686

HighFDA (Devices)·Z-1155-2014·2014-03-19
Philips HeartStart MRx Monitor/Defibrillator Recalled for Shock Delivery Failure
Philips is recalling HeartStart MRx Monitor/Defibrillators because they may display a Red X during automated tests, indicating a failure that could prevent the delivery of a shock or pacing.
Product
Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1198-2014·2014-03-19
GE Healthcare Recalls Infinia Nuclear Medicine Systems for Detector Motion Risk
GE Healthcare is recalling Infinia and Infinia Hawkeye Nuclear Medicine Systems due to a potential safety issue where the detector may drift toward the patient.
Product
GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1182-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a reported issue with the plunger tip. The devices are sterile, single-use in-vitro diagnostic tools used for drawing arterial blood.
Product
4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line.…
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-1151-2014·2014-03-19
Megadyne Recalls Suction Coagulators Due to Self-Activation Risk
Megadyne Medical Products is voluntarily recalling specific lots of Hand Control 12FR Suction Coagulators because they may self-activate when connected to a generator.
Product
Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU)…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1170-2014·2014-03-19
Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure
Biomet 3i is recalling 250 Contra-Angle Torque Driver Kits because the included surgical trays failed to meet required Sterility Assurance Levels during validation testing.
Product
Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1143-2014·2014-03-12
Phillips Respironics Recalls Trilogy Ventilators Due to Power Board Defect
Phillips Respironics is recalling 572 Trilogy ventilators worldwide because a defective power management board component may cause loss of therapy.
Product
Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1060-2014·2014-03-12
McKesson Anesthesia Care System Recalled for Data Mismatch
McKesson Technologies is recalling 10 units of the Anesthesia Care system because patient case data did not match the patient data, including data from another case.
Product
McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1150-2014·2014-03-12
Shimadzu Recalls Mobile X-ray Systems Due to Metal Plate Cracking Risk
Shimadzu Medical Systems is recalling 56 mobile X-ray systems because a connecting metal plate may crack, posing a structural safety risk.
Product
Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1119-2014·2014-03-12
Greatbatch Medical Recalls Offset Cup Impactor Due to Sterility Assurance Concerns
Greatbatch Medical is recalling Standard Offset Cup Impactors because internal testing showed the specified sterilization cycles may not achieve the required sterility assurance level.
Product
Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, T12699, T12767, T12861, T13344, T13480, T13642, T13722, T13999, T14155, T14384…
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1082-2014·2014-03-12
Elekta Desktop Pro Linear Accelerator Control Software Recalled for Calibration Errors
Elekta, Inc. is recalling Desktop Pro linear accelerator control software because incorrect values may be entered during calibration procedures.
Product
Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1081-2014·2014-03-12
Elekta RT Desktop Software Recall for Calibration Input Errors
Elekta is recalling RT Desktop software because users may enter incorrect values during calibration procedures for radiation therapy linear accelerators.
Product
RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a…
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-1084-2014·2014-03-12
Elekta Agility Software Recall for Calibration Input Errors
Elekta is recalling Agility software version 3.0 because incorrect values can be entered during calibration procedures for medical linear accelerators.
Product
Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1085-2014·2014-03-12
Elekta Agility software recall for potential calibration input errors
Elekta is recalling Agility software version 3.1 for linear accelerators because incorrect values could be entered during calibration procedures.
Product
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1134-2014·2014-03-12
DeRoyal Circumcision Clamps Recalled for Manufacturing Defects
DeRoyal Industries is recalling three lots of circumcision clamps that may not clamp completely at the surgical site due to manufacturing errors.
Product
DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1083-2014·2014-03-12
Elekta Integrity Software Recalled for Calibration Input Errors
Elekta, Inc. is recalling Integrity Version 1.1 software for linear accelerators because incorrect values can be entered during calibration procedures.
Product
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1147-2014·2014-03-12
GE Healthcare Recalls Solar 8000M/i Patient Monitors Due to AVOA Feature Failure
GE Healthcare is recalling Solar 8000M and 8000i patient monitors because the Automatic-View-On-Alarm feature may stop functioning after a specific discharge event.
Product
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1128-2014·2014-03-12
Carestream Recalls Kodak 2200 Intraoral X-Ray Systems Due to Arm Failure
Carestream Health is recalling Kodak 2200 Intraoral X-Ray Systems because the device arms may break early. This affects 347 units distributed in the US and Canada.
Product
Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France -- --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1124-2014·2014-03-12
Medical Information Technology Recalls MEDITECH Microbiology Calculator Module
Medical Information Technology, Inc. is recalling MEDITECH Microbiology calculator modules due to a risk of patient results being removed from laboratory and electronic medical record systems.
Product
MEDITECH Microbiology - Calculator/data processing module, for clinical use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1127-2014·2014-03-12
Carestream Recalls Kodak 2100 Intraoral X-Ray Systems Due to Arm Breakage
Carestream Health is recalling Kodak 2100 Intraoral X-Ray Systems because the device arms may break early. The recall covers 347 units distributed in the US and Canada.
Product
Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0957-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0950-2014·2014-03-05
Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0951-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Hazard
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during use, potentially compromising the patient's airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0956-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0952-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0954-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Hazard
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide

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25301–25325 of 27686