← FDA ENFORCEMENT
Z-3028-2026Class 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
419 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) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.

Code / lot info

Medline Kit SKU DYNJ54362F, UDI/DI 10198459794292 (each) 40198459794293 (case), Lot Number 26EMF986; Medline Kit SKU DYNJ900957C, UDI/DI 10195327599461 (each) 40195327599462 (case), Lot Number 25IBP434; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 26BBA665; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 25KBR602; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 25JBH531; Medline Kit SKU DYNJ910195A, UDI/DI 10198459556838 (each) 40198459556839 (case), Lot Number 25KBL876; Medline Kit SKU DYNJ910195A, UDI/DI 10198459556838 (each) 40198459556839 (case), Lot Number 25JBS218.

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 →