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

25901–25925 of 27686

HighFDA (Devices)·Z-0060-2014·2013-10-30
Integra Licox Brain Tissue Oxygen Monitoring Kit Recall for Hex Wrench Defect
Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because a hex wrench may fail to loosen the set screw on the drill bit.
Product
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0051-2014·2013-10-30
Synergetics 25 Gauge Soft Tip Cannula Recall Due to Gauge Mislabeling
Synergetics Inc is recalling 25 gauge Soft Tip Cannulas because some units are co-mingled with 23 gauge cannulas but labeled as 25 gauge.
Product
Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0045-2014·2013-10-30
Merit Medical Recalls Performa Angiographic Catheters Due to Tip Shape Variation
Merit Medical Systems is recalling 200 units of Performa Angiographic Catheters because four lots contain a catheter with a slight variation in tip shape.
Product
Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0034-2014·2013-10-30
GE Healthcare Recalls Centricity Cardio Imaging 5.0 Software
GE Healthcare is recalling Centricity Cardio Imaging 5.0 software due to a potential image labeling error in the Image Viewer that may affect diagnostic interpretation.
Product
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0010-2014·2013-10-23
GE Healthcare Recalls Ventilators and Anesthesia Machines with Unresponsive Buttons
GE Healthcare is recalling 911 ventilators and anesthesia machines because manufacturing defects may cause display buttons to fail, preventing access to menu functions.
Product
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0009-2014·2013-10-23
GE Healthcare Recalls Anesthesia Devices Due to Tidal Volume Overdelivery Risk
GE Healthcare is recalling specific anesthesia devices because they may deliver excessive tidal volume in a specific ventilation mode, posing a risk of harm to patients.
Product
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0024-2014·2013-10-23
GE PET Discovery 610 and 710 Recalled for Image Series UID Conflict
GE Healthcare is recalling PET scanners because a software issue may cause different image series to share the same ID, potentially leading to incorrect image display.
Product
GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0025-2014·2013-10-23
Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion
Boston Scientific is recalling COGNIS CRT-D devices because a capacitor defect may cause premature battery depletion.
Product
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0026-2014·2013-10-23
Boston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion Risk
Boston Scientific is recalling TELIGEN implantable cardiac defibrillators because a capacitor defect may cause premature battery depletion.
Product
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0011-2014·2013-10-23
Siemens Recalls ADVIA Hematology Systems Due to Sample Labeling Error Risk
Siemens is recalling ADVIA 2120/2120i hematology systems connected to an ADVIA Autoslide because a rack jam error could cause the next slide to be labeled with the wrong sample identification information.
Product
ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0014-2014·2013-10-23
Synthes Midfoot Fusion Bolt Recall for Technique Guide Clarification
Synthes USA is recalling 62 Midfoot Fusion Bolts to update the technique guide, emphasizing supplemental fixation to reduce the risk of bolt back-out or migration.
Product
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0018-2014·2013-10-23
Getinge 46-Series Washer-Disinfectors Recalled for Overheating Risk
Getinge Disinfection is recalling 46-Series medical washer-disinfectors due to a possible overheating hazard. The voluntary field safety correction affects 143 units distributed in the US and Canada.
Product
Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0012-2014·2013-10-23
GE Healthcare X-ray Systems Recalled for Loose Power Assist Handle Bolts
GE Healthcare is recalling 810 X-ray systems because internal bolts on the power assist handle may loosen or fall out, potentially causing the handle to stick in the ON position.
Product
GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0022-2014·2013-10-23
Harvest Graft Delivery System Recalled for Potential Luer Connector Leaks
Harvest Technologies is recalling 730 cases of the Harvest Graft Delivery System because the Luer connector may leak or crack.
Product
Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0019-2014·2013-10-23
Philips MX 16-Slice CT Scanner Recalled for Pinch Point Injury Risk
Philips Medical Systems is recalling 326 MX 16-Slice CT Scanner Systems because a pinch point at the end of the table top can cause injury.
Product
MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0015-2014·2013-10-23
OSOM C. Difficile Toxin A/B Test Kit Recalled for False Negative Risk
Sekisui Diagnostics is recalling specific lots of the OSOM C. Difficile Toxin A/B Test Kit due to the potential for false negative results.
Product
Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0008-2014·2013-10-16
Draeger Fabius Anesthesia Machines Recalled for Electrical Clearance Defects
Draeger Medical is recalling 1,127 Fabius anesthesia machines worldwide because some units failed high-voltage tests and did not maintain minimum electrical clearance.
Product
Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0007-2014·2013-10-16
Bard Recalls LifeStent Solo Vascular Stents Due to Deployment Issues
Bard Peripheral Vascular is recalling specific lots of LifeStent Solo Vascular Stents due to a higher incidence of partial stent deployment.
Product
Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2298-2013·2013-10-09
MedStream Refill Kit Recalled for Excessive Drug Flow Rates
Codman & Shurtleff, Inc. is recalling MedStream Refill Kits because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2295-2013·2013-10-09
MedStream Refill Kit Recalled for Excessive Drug Flow Rates
Codman & Shurtleff is recalling MedStream Refill Kits because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2293-2013·2013-10-09
MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff is recalling two MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2272-2013·2013-10-09
King Systems Universal Flex2 Breathing Circuit Recalled for Latex Mislabeling
King Systems Corp. is recalling Universal Flex2 Breathing Circuits that contain latex bags but are labeled as non-latex.
Product
Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2294-2013·2013-10-09
MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff is recalling MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2299-2013·2013-10-09
Codman MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff, Inc. is recalling 369 MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2297-2013·2013-10-09
MedStream Refill Kit Recall for Excessive Drug Flow Rates
Codman & Shurtleff is recalling MedStream Refill Kits because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use…
Category
Medical Device
Distribution
Distributed nationwide

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25901–25925 of 27686