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All product recalls associated with Sgarlato Med, LLC.
Total Recalls
1000
Past Year
1000
Class I (Serious)
127
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Products with an expiration date of August, 2009 were labeled with an expiration date of May 2013. Additionally, the outer packages were labeled with an incorrect lot number. The outer and inner packages did not match.
Cracks may form around the screw connections of the cover plates causing brittleness, which may lead to fragments breaking off and falling into the operating area.
Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
This recall involves model 909S Sam Yang .45 caliber rifles shipped to consumers after July 1, 2008. The rifle is a precharged pneumatic air rifle, powered by compressed air.
The crimped hoses are used to carry the air supply in the re-breathing diving system. The hoses were sold on three re-breathing models: Inspiration, Evolution and Evolution Plus. Hoses with a smooth (uncrimped) collar and with the model numbers listed below are included in the recall: AP300/15 ADV Supply Hose RB20/03 Oxygen Injection Hose EV20/03 Oxygen Injection Hose RB20/10 Buzzer Hose EV11A/1 Vision Handset Hose RB11A/1 Classic Handset Hose RB11/B Handset Hose AP300/10 ADV Hose AP300/38 ADV Hose Hoses with eight flats on the hose collar have been crimped and are not included in the recall.
Instructions for the use of the pinch clamp that is an integral part of the TheraSphere Administration Set were not included with the distribution of the device.
A software anomaly in the TumorLoc software for the firm's Brilliance CT scanners was discovered. The same software anomaly was subsequently determined to be present in the firm's GEMINI PET/CT units. The software defect results in a the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.
The recall involves Evenflo ExerSaucer Triple Fun stationary activity centers made between October 2006 and December 2008. The model number is 6231711. Stage 3 position involves converting the product into an activity table. No other ExerSaucer models use end caps and, therefore, no other models are included in this recall.
The recall includes the Kid Pullover Hood and Kid Zipper with Hood. The Kid Pullover Hood has a flat style drawstring at the neck, one middle front pocket, and fleece inside lining. Top sewn in label reads "HILL/ Made in USA." The hooded Zipper children's sweatshirt has a rounded style drawstring at the neck, two front pockets, and fleece inside lining. Top sewn in label reads "HILL/ Made in USA".
Labeled with extended expiration date (24 months instead of 18 months)
The halogen clamp lamps, also known as architect's lamps, have a 150-watt halogen bulb, an articulating arm, and a clamp desk lamp that adjusts up, down and swivels. Only lamps with model number 13456-US and lot numbers C06081581V185, C06081582V185 and C06081584V185 are included in the recall.
This recall involves the "Field & Stream" dual burner camp stove, which is a propane-fueled portable stove. The style number (#CEH00475) can be located on the product's packaging. The "Field & Stream" logo is on the back panel of the stove behind the burners.
The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
Focal Software: if individual MLC leaf position edits are made, the original MLC aperture is retained. A subsequent aperture edit should not affect the MLC leaf positions however it was found that instead the leaves will then snap (unintentionally) back to the original aperture. Also, if the patient is sent to XiO after the MLC is edited, an isocenter shift made in XiO will also cause the MLCs to
The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
This recall includes R-SYS and R-SYS Premium front wheel rims. They were sold as original equipment on various bicycle brands and were also sold separately. R-SYS wheel rims are designed for road bikes. "R-SYS" is printed on the front rim of the wheels. The rims are 22mm in diameter, with 16 tubular, unidirectional carbon spokes.
ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB.
It was reported by a customer site that when using Advantage Sim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.
Review by firm of Philips EasyVision MM workstations found that to assure compliance with 21 CFR 900.12(c)(5) corrected software was needed so that all sites are in compliance.