FDAFDA recall Z-3024-2026 · Sep 2, 2026

Medline Industries, LP: Medline convenience kits labeled as: 1) MAJOR GYN PACK recall

Recall found

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

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: 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.
Quantity: 663 kits
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.
Recalling firm: Medline Industries, LP, Northfield, IL
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-07-10

Source: openFDA enforcement record Z-3024-2026 · search recall number Z-3024-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.