← FDA ENFORCEMENT
Z-3024-2026Class II

Medline Industries, LP

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-09-02
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.
Firm state
IL
Product quantity
663 kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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.

Code / lot info

Medline Kit SKU DYNJG001030C, UDI/DI 10198459729614 (each) 40198459729615 (case), Lot Number 26CLA636; Medline Kit SKU DYNJT8166, UDI/DI 10198459697739 (each) 40198459697730 (case), Lot Number 26DBG173; Medline Kit SKU DYNJT8166, UDI/DI 10198459697739 (each) 40198459697730 (case), Lot Number 26CBT177; Medline Kit SKU DYNJ47638B, UDI/DI 10198459219221 (each) 40198459219222 (case), Lot Number 26DBL480; Medline Kit SKU DYNJ47638B, UDI/DI 10198459219221 (each) 40198459219222 (case), Lot Number 26CBQ902; Medline Kit SKU DYNJ900949C, UDI/DI 10195327076344 (each) 40195327076345 (case), Lot Number 25IBR180; Medline Kit SKU DYNJ903470G, UDI/DI 10195327678562 (each) 40195327678563 (case), Lot Number 26ADA465; Medline Kit SKU DYNJ908879G, UDI/DI 10198459377419 (each) 40198459377410 (case), Lot Number 25LBU940; Medline Kit SKU DYNJ910178A, UDI/DI 10198459320682 (each) 40198459320683 (case), Lot Number 25IBU845; Medline Kit SKU DYNJ910281B, UDI/DI 10198459586385 (each) 40198459586386 (case), Lot Number 26ABI051; Medline Kit SKU DYNJ910832A, UDI/DI 10198459425653 (each) 40198459425654 (case), Lot Number 25KBH197; Medline Kit SKU DYNJ911236, UDI/DI 10198459302299 (each) 40198459302290 (case), Lot Number 26BBB487; Medline Kit SKU DYNJ911236, UDI/DI 10198459302299 (each) 40198459302290 (case), Lot Number 25IBS529; Medline Kit SKU DYNJ911243, UDI/DI 10198459302329 (each) 40198459302320 (case), Lot Number 26CBM128; Medline Kit SKU DYNJ911243, UDI/DI 10198459302329 (each) 40198459302320 (case), Lot Number 25JBI549; Medline Kit SKU DYNJ911245, UDI/DI 10198459302336 (each) 40198459302337 (case), Lot Number 25IBP079; Medline Kit SKU DYNJ911332, UDI/DI 10198459326103 (each) 40198459326104 (case), Lot Number 25LBC312; Medline Kit SKU DYNJ911332, UDI/DI 10198459326103 (each) 40198459326104 (case), Lot Number 25KBM427; Medline Kit SKU DYNJ911332A, UDI/DI 10198459714511 (each) 40198459714512 (case), Lot Number 26DBO888; Medline Kit SKU DYNJ911332A, UDI/DI 10198459714511 (each) 40198459714512 (case), Lot Number 26DBF153.

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →