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

25951–25975 of 27722

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
SevereFDA (Devices)·Z-2300-2013·2013-10-09
MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff, Inc. is recalling 735 MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Programmable Pump; 20ml Pump EMEA 91-4200 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-2296-2013·2013-10-09
MedStream Refill Kit Recalled for Excessive Drug Flow Rates
Codman & Shurtleff is recalling MedStream Refill Kits because they may allow drug flow rates to exceed programmed levels.
Product
MedStream Refill Kit (1 unit), EMEA: 91-4289 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
SevereFDA (Devices)·Z-0006-2014·2013-10-09
H&H Emergency Cricothyrotomy Kit Recall for Weakened Tubing
H & H Associates is recalling 6,619 Emergency Cricothyrotomy Kits because the medical device tubing may become weakened and ineffective.
Product
H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2273-2013·2013-10-09
CareFusion Recalls AVEA Ventilators for Barometric Pressure Error
CareFusion is voluntarily correcting AVEA ventilators to fix a barometric pressure compensation error identified during a proactive review.
Product
Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0005-2014·2013-10-09
PhotoMedex Recalls SLT Fiber Delivery Systems Due to Sterility Concerns
PhotoMedex is recalling 549 units of SLT Fiber Delivery Systems because some may not have been sealed appropriately, compromising the sterile barrier.
Product
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2318-2013·2013-10-09
McKesson Horizon Medical Imaging System Recalled for Potential Image Loss
McKesson Information Solutions LLC is recalling Horizon Medical Imaging software versions 4.6.1 to 11.6. because a server configuration malfunction may cause the loss of digital medical images.
Product
McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0001-2014·2013-10-09
Maquet Recalls Ultima OPCAB Systems Due to Incorrect Blade Labeling
Maquet Cardiovascular is recalling specific lots of Ultima OPCAB Systems because standard and deep blades were incorrectly labeled, posing a risk during cardiac surgery.
Product
Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2292-2013·2013-10-09
Ebi Solitaire-35 Spinal Fusion Device Recalled for Screw Complaints
Ebi, LLC is recalling 1,730 units of the Solitaire-35 PEAK Solitaire Anterior Spinal System due to complaints regarding one of the three screws driving through the cage.
Product
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
Category
Medical Device
Distribution
Distributed nationwide

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