FDA Medical Device Recalls

Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025

HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.

Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

Root cause: Storage

Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Single (Specified) Analyte Controls (Assayed And Unassayed)Distribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1855-2025

Open, ClassifiedPosted May 23, 2025·Initiated Apr 23, 2025

Apo B Reagent, REF: OSR6143

Reason: The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.

Root cause: Error in labeling

Recalling firm: Beckman Coulter Ireland, Inc.Type: Turbidimetric Method, LipoproteinsDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MD, MI, NJ, NY, OH, OK, OR, PA, TX, VA, WA, WV and the countries of Argentina, Australia, Belarus, Belgium, Bulgaria, Canada, China, Czechia, Egypt, Estonia, France, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Netherlands, New Zealand, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland, United States of America, Viet Nam.Recall #Z-1815-2025

Open, ClassifiedPosted May 23, 2025·Initiated May 6, 2025

Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P3700E100450, P3700E100453, P3700E100455, P3700E100456, P3700E100457, P3700E100459, P3700E100463, P3700E100468, P3700E100472, P3700E100476, and P3700E100477

Reason: There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.

Root cause: Nonconforming Material/Component

Recalling firm: Baxter Healthcare CorporationType: Table, Obstetric (And Accessories)Distribution: Worldwide distribution - US Nationwide and the countries of BAHRAIN, Canada, Chile, FRANCE, KUWAIT, NETHERLANDS, NORWAY, UNITED ARAB EMIRATES.Recall #Z-1816-2025

Open, ClassifiedPosted May 23, 2025·Initiated Dec 22, 2023

ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.

Reason: Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.

Root cause: Labeling Change Control

Recalling firm: Onkos Surgical, Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedDistribution: US Nationwide distribution in the states of California, Kentucky, and Wisconsin.Recall #Z-1817-2025

Open, ClassifiedPosted May 23, 2025·Initiated Dec 22, 2023

ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.

Reason: Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.

Root cause: Labeling Change Control

Recalling firm: Onkos Surgical, Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedDistribution: US Nationwide distribution in the states of California, Kentucky, and Wisconsin.Recall #Z-1818-2025

Open, ClassifiedPosted May 22, 2025·Initiated Mar 5, 2025

HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

Reason: Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

Root cause: Under Investigation by firm

Recalling firm: Advanced Bionics, LLCType: Implant, CochlearDistribution: U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/ARecall #Z-1813-2025

Open, ClassifiedPosted May 21, 2025·Initiated Apr 11, 2016

TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.

Reason: Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.

Root cause: Software design

Recalling firm: Echopixel, Inc.Type: System, Image Processing, RadiologicalDistribution: Worldwide - U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL and the country of Canada.Recall #Z-1807-2025

Open, ClassifiedPosted May 21, 2025·Initiated Apr 21, 2025

BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862

Reason: Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.

Root cause: Process control

Recalling firm: Becton Dickinson Infusion Therapy Systems, Inc.Type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysDistribution: Worldwide - US Nationwide distribution in the states of IN, AL, CA, FL, TX, NJ, MO, NC, NY, OH, AZ, MN, MA, WA, OK, KS, MS, LA, MD, GA, TN, NM, PA and the country of CA.Recall #Z-1808-2025

Open, ClassifiedPosted May 21, 2025·Initiated May 6, 2025

PhenoMATRIX

Reason: AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.

Root cause: No Marketing Application

Recalling firm: Copan WASPType: Automated Colony CounterDistribution: US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.Recall #Z-1812-2025

Open, ClassifiedPosted May 20, 2025·Initiated Apr 22, 2025

Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35

Reason: Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.

Root cause: Device Design

Recalling firm: Ethicon Endo-Surgery IncType: Staple, ImplantableDistribution: US distribution nationwide. OUS distribution to EMEA, LATAM, APAC, and Canada.Recall #Z-1746-2025

Open, ClassifiedPosted May 20, 2025·Initiated Apr 17, 2025