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FDA (Device enforcement)Recalled 2026-07-10class ii

Medline Industries, LP: 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 DYNJ

Is my product affected?

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

  • UPC 10198459729614
  • UPC 40198459729615
  • UPC 10198459697739
  • UPC 40198459697730
  • UPC 10198459219221
  • UPC 40198459219222
  • UPC 10195327076344
  • UPC 40195327076345
  • UPC 10195327678562
  • UPC 40195327678563
  • UPC 10198459377419
  • UPC 40198459377410
  • UPC 10198459320682
  • UPC 40198459320683
  • UPC 10198459586385
  • UPC 40198459586386
  • UPC 10198459425653
  • UPC 40198459425654
  • UPC 10198459302299
  • UPC 40198459302290
  • UPC 10198459302329
  • UPC 40198459302320
  • UPC 10198459302336
  • UPC 40198459302337
  • UPC 10198459326103
  • UPC 40198459326104
  • UPC 10198459714511
  • UPC 40198459714512

Check against the official notice below — it lists the full affected range.

What happened

Medline Industries, LP is recalling 663 convenience kits that contain potentially contaminated components previously recalled by a manufacturer. The affected kits include Major Gyn Packs, Gyn Lithotomy Packs, and Open Heart Packs distributed nationwide across 18 states: Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas, and Wisconsin. Multiple lot numbers are involved across various SKUs with specific UDI codes and lot identifiers listed for each product variant.

The specific lot numbers and SKU codes affected by this recall are detailed in the official recall record, which consumers can use to identify whether their kits are included. The source document does not specify a remedy or required action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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. Quantity: 663 kits Lot/code 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),

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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