🍔 Food 💊 Drugs 🏥 Medical Devices
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No Class II

Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Edan Diagnostics 20251024 Ongoing
Distributed: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
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Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the sit-to-stand motion. Class II

Reason: Potential for fraying on the body support strap.

Community Products, LLC 20251218 Ongoing
Distributed: Worldwide distribution - US Nationwide and the countries of UAE, Australia, Canada, EU, Israel, Hong Kong, Japan, Korea, New Zealand, Russia, Saudi Arabia, and UK.
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Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. The low base variant includes smaller casters and lower base frame so that the legs fit underneath beds. Class II

Reason: Potential for fraying on the body support strap.

Community Products, LLC 20251218 Ongoing
Distributed: Worldwide distribution - US Nationwide and the countries of UAE, Australia, Canada, EU, Israel, Hong Kong, Japan, Korea, New Zealand, Russia, Saudi Arabia, and UK.
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Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. Class II

Reason: Potential for fraying on the body support strap.

Community Products, LLC 20251218 Ongoing
Distributed: Worldwide distribution - US Nationwide and the countries of UAE, Australia, Canada, EU, Israel, Hong Kong, Japan, Korea, New Zealand, Russia, Saudi Arabia, and UK.
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TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17 Class II

Reason: Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.

Sysmex America, Inc. 20251215 Ongoing
Distributed: US Nationwide.
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The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample. Class II

Reason: Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).

Beckman Coulter Ireland, Inc. 20251208 Ongoing
Distributed: US: MD, NJ, OH, FL, CA, TX, NC, WA, MA, NV, GA, CO, PA, NM, UT, VA, KS, MT, OK, NY, AZ, LA, OR, AL, MO, IN, IL, KY, MS, NH, AK, SD, MN, TN, PR, MI, IA, WI, WV, ME, SC, HI, RI, ND, NE, ID, AR, WY, DC, GU, DE, CT. OUS: Brazil, South Africa, Argentina, Mexico, Canada, Costa Rica, Peru, El Salvador, Ecuador, Panama, Singapore, Ireland, United Kingdom of Great Britain and Northern Ireland, Germany, China, Korea, Republic of
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Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/A Class II

Reason: Due to probe bags that may have a compromised or incomplete sterile pouch seal.

Intuitive Surgical, Inc. 20251204 Ongoing
Distributed: U.S.: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MA, MD, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. O.U.S.: Australia, China, France, Germany, Italy, Japan, South Korea, Spain, Switzerland, and United Kingdom
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Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Class II

Reason: Due to products not having FDA Premarket authorization to be distributed within the United States.

MicroPort Orthopedics Inc. 20251219 Ongoing
Distributed: The product was sent to distributors in multiple US states, including Texas, California, Wisconsin, Kansas, Illinois, Michigan, Tennessee, Maryland, Washington, Georgia, Colorado, Missouri, and Florida. The product was also sent to the following countries: Belgium, Germany, France, Italy, United Kingdom, Japan, and China.
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Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No Class II

Reason: The supplier manufactured anatomical left plates with an incorrect thread orientation.

Tyber Medical 20251219 Ongoing
Distributed: US Nationwide distribution in the state of PA.
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Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm Class II

Reason: The supplier manufactured anatomical left plates with an incorrect thread orientation.

Tyber Medical 20251219 Ongoing
Distributed: US Nationwide distribution in the state of PA.
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