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

37426–37450 of 40449

ModerateFDA (Devices)·Z-0013-2014·2013-10-23
Philips CT Scanners Recalled for Image Artifacts During Specific Scans
Philips is recalling 258 CT scanners because artifacts appear on images during threshold-triggered bolus scans using a 0.4-second rotation time.
Product
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce…
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
HighFDA (Devices)·Z-2301-2013·2013-10-09
Hologic Selenia Mammography System Software Recall for Image Deletion
Hologic is recalling 62 Selenia Full Field Digital Mammography Systems because software versions 5.0.x and 5.1.x may delete recent images when the hard drive reaches a 4,000-image threshold.
Product
Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-2312-2013·2013-10-09
Atrium Medical Recalls Advanta SuperSoft Grafts Due to Label Adhesion
Atrium Medical Corporation is recalling Advanta SuperSoft Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2306-2013·2013-10-09
Atrium Medical Recalls Advanta SuperSoft Grafts Due to Label Adhesion
Atrium Medical Corporation is recalling Advanta SuperSoft Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2309-2013·2013-10-09
Atrium Medical Recalls Advanta VS Grafts Due to Label Adhesion Issue
Atrium Medical Corporation is recalling Advanta VS Grafts because the inner tray label may adhere to the outer tray, making removal difficult.
Product
Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2304-2013·2013-10-09
Atrium Medical Recalls Advanta VXT Vascular Grafts Due to Label Adhesion
Atrium Medical Corporation is recalling Advanta VXT Vascular Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0003-2014·2013-10-09
Cordis ADROIT 6F Guiding Catheter Recalled for Labeling Error
Cordis Corporation is recalling 1,238 units of ADROIT 6F Guiding Catheters due to a labeling error regarding the conversion of the inner diameter from inches to millimeters.
Product
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0004-2014·2013-10-09
ASO Recalls SHOPKO Waterproof Adhesive Pads Labeled as Antibacterial
ASO, LLC is recalling SHOPKO Waterproof Adhesive Pads because they were labeled as antibacterial but did not contain antibacterial ingredients.
Product
SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
Category
Medical Device
Distribution
4 states

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37426–37450 of 40449