FDA Medical Device Recalls

Open, ClassifiedPosted Jan 22, 2026·Initiated Oct 24, 2025

Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. Component: No

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.

Root cause: Device Design

Recalling firm: Edan DiagnosticsType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: 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.Recall #Z-1155-2026

Open, ClassifiedPosted Jan 22, 2026·Initiated Dec 22, 2025

Patient Information Center iX; Software Version Number: 4.5.0

Reason: A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.

Root cause: Software Design Change

Recalling firm: Philips North AmericaType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Canada, Czech Republic, Dominican Rep, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Utd.Arab.Emir.Recall #Z-1156-2026

Open, ClassifiedPosted Jan 22, 2026·Initiated Nov 3, 2025

SQ40S Blood Transfusion Filter

Reason: Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.

Root cause: Process control

Recalling firm: GVS TM, IncType: Microfilter, Blood TransfusionDistribution: U.S.: ID, NV, SC, MO, TX, CO, MD, CA, VA, DC, PA, IL, OH, AZ, FL, OK, MN, KY, OR, NE, NC, LA, MS, MI, NY, GA, AL, MARecall #Z-1157-2026

Open, ClassifiedPosted Jan 21, 2026·Initiated Dec 4, 2025

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

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

Root cause: Process control

Recalling firm: Intuitive Surgical, Inc.Type: Bronchoscope (Flexible Or Rigid)Distribution: 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 KingdomRecall #Z-1134-2026

Open, ClassifiedPosted Jan 21, 2026·Initiated Dec 8, 2025

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.

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).

Root cause: Device Design

Recalling firm: Beckman Coulter Ireland, Inc.Type: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlDistribution: 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 ofRecall #Z-1135-2026

Open, ClassifiedPosted Jan 21, 2026·Initiated Dec 15, 2025

TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17

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

Root cause: Software design

Recalling firm: Sysmex America, Inc.Type: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseDistribution: US Nationwide.Recall #Z-1136-2026

Open, ClassifiedPosted Jan 20, 2026·Initiated Dec 19, 2025

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

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

Root cause: Process control

Recalling firm: Tyber MedicalType: Plate, Fixation, BoneDistribution: US Nationwide distribution in the state of PA.Recall #Z-1131-2026

Open, ClassifiedPosted Jan 20, 2026·Initiated Dec 19, 2025

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

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

Root cause: Process control

Recalling firm: Tyber MedicalType: Plate, Fixation, BoneDistribution: US Nationwide distribution in the state of PA.Recall #Z-1132-2026

Open, ClassifiedPosted Jan 20, 2026·Initiated Dec 19, 2025

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

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

Root cause: No Marketing Application

Recalling firm: MicroPort Orthopedics Inc.Distribution: 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.Recall #Z-1133-2026