FDA recall Z-3024-2026

Product

Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAVINCI, Medline Kit SKU DYNJ900949C; 5) THORACIC, Medline Kit SKU DYNJ903470G; 6) CV PART 1 AND 2, Medline Kit SKU DYNJ908879G; 7) GENERAL ROBOTIC, Medline Kit SKU DYNJ910178A; 8) AMB GYN LAPAROSCOPY KT, Medline Kit SKU DYNJ910281B; 9) DIEP FLAP, Medline Kit SKU DYNJ910832A; 10) C-SECTION, Medline Kit SKU DYNJ911236; 11) LAPAROTOMY, Medline Kit SKU DYNJ911243; 12) OPEN HEART A&B, Medline Kit SKU DYNJ911245; 13) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332; 14) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332A.

Reason for recall

Kits contain a potentially contaminated component which were recalled by the manufacturer

Distribution

US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.

Key facts

Status

Ongoing

Initiation date

2026-07-10

Report date

2026-09-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3024-2026