FDA Medical Device Recalls

Open, ClassifiedPosted Feb 26, 2025·Initiated Jan 29, 2025

PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c

Reason: During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.

Root cause: Device Design

Recalling firm: Pentax of America IncType: Endoscope, Accessories, Image Post-Processing For Color EnhancementDistribution: NationwideRecall #Z-1237-2025

Open, ClassifiedPosted Feb 26, 2025·Initiated Jan 29, 2025

Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c

Reason: During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.

Root cause: Device Design

Recalling firm: Pentax of America IncType: Endoscope, Accessories, Image Post-Processing For Color EnhancementDistribution: NationwideRecall #Z-1238-2025

Open, ClassifiedPosted Feb 25, 2025·Initiated Feb 3, 2025

LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.

Reason: Incorrect keypad was incorrectly installed onto a defibrillator/monitor.

Root cause: Employee error

Recalling firm: Physio-Control, Inc.Type: Automated External Defibrillators (Non-Wearable)Distribution: U.S.: WV O.U.S.: N/ARecall #Z-1232-2025

Open, ClassifiedPosted Feb 25, 2025·Initiated Jan 10, 2025

DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

Reason: Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.

Root cause: Software change control

Recalling firm: BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: US: MA, CA, SC, LA, OK, GA, AL, TX, OR, ID, CO, MN, NY, MS, PA, WA, IL, MI, PR. OUS: Lebanon, Poland, Ghana, Spain, South Africa, Slovakia, Ghana, Croatia, Seychelles, Australia, Republic of KoreaRecall #Z-1233-2025

Open, ClassifiedPosted Feb 24, 2025·Initiated Jan 23, 2025

BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration

Reason: Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.

Root cause: Under Investigation by firm

Recalling firm: CareFusion 303, Inc.Type: Pump, InfusionDistribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Guantanamo Bay, Cuba O.U.S.: CanadaRecall #Z-1231-2025

Open, ClassifiedPosted Feb 21, 2025·Initiated Jan 10, 2025

BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.

Reason: Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.

Root cause: Labeling design

Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: US Nationwide distribution including in the states of AZ, FL, NJ, KY, GA, CA, IL, MD, WI, OH, NC, MS, NY, MO, PA, OR, IN, TX, UT, OK, MI, WA, AL, NV, ME, WV, NE, DC, MA, MT, KS, CO, TN, IA, MN, AR, ID, SC, SD, CT, HI, VA, ND, AK, NM, VT, LA, WY.Recall #Z-1206-2025

Open, ClassifiedPosted Feb 21, 2025·Initiated Jan 23, 2025

BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies to a qualified and authorized user in a clinical setting.

Reason: Due to fingerprint scanner failing resulting in the scanner heating up.

Root cause: Nonconforming Material/Component

Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI , IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, and WY. The countries of Australia, Bahrain, Belgium, Brazil, Canada, Hong Kong, Kuwait, Lebanon, New Zealand, Qatar, Saudi Arabia, Spain, and Thailand.Recall #Z-1207-2025

Open, ClassifiedPosted Feb 21, 2025·Initiated Feb 5, 2025

IntelePACS (Image Fusion Module) - InteleViewer

Reason: A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.

Root cause: Software design

Recalling firm: INTELERAD MEDICAL SYSTEMS INCORPORATEDType: System, Image Processing, RadiologicalDistribution: Worldwide - US Nationwide distribution in the states of AZ, NC, MI, FL, NH, WY, CA, SC, AL, AR, IN, MD, CO, TN, IL, NJ, OH, MN, WV, KE, NE, VA, WA, GE, WI and the countries of New Zealand, Canada, AustraliaRecall #Z-1208-2025

Open, ClassifiedPosted Feb 21, 2025·Initiated Jan 21, 2025