FDA Device Recalls

Class IIOngoing

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER 2 ACC010690 ACC010875 DRAWER 3 SYR/DRS/MON/NG 1 OF 3 ACC011073 DRAWER 4 CIRCULATION ACC011088 DRAWER 5 - LEFT BOX ACC011067 LABOR TRIAGE KIT - LF #13232 DYKM1564 DYKM1564A LINEN UNIVERSAL PACK DYNJT10325 MAC KIT DYKS1089B NICU LINE PACK DYNJ63410 PEDIATRIC BLOOD CULTURE KIT DYNDH1363 RRMC CODE CART DRAWER 3 ACC010770 STANFORD TIME TO POSITIVITY DYNDH1591 STUDENT PRACTICE BAG W LOGO EDUC1043 EDUC1043A SUTURED SHEATH W/SCI #113198 DYKM1496 IV START KIT DYNDV2520

Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

July 20, 2026 · DeviceView details →

Ami HTX

Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N

Velys Enabling Tech Robotic-Assist Station REF: 451611001

Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection Kit, REF: 81834C. All containing BD ChloraPrep Clear - 1 mL Applicators

Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02

Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793300R0, M006793300D0, M006793300Z0, M0067930000, M006793000R0

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01

FUJIFILM Synapse PACS software v7.4.310; radiological image processing system

Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A

PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB

PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592

Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;

Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.

FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225