medical MODERATE Updated 2026-09-02

Medline Industries, LP recalls Medline convenience kits labeled as: 1) OPEN HEART PACK,

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Recalled Product

Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W; 6) PACK,OPEN HEART, Medline Kit SKU DYNJ906903F; 7) PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C; 8) ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F; 9) OPEN HEART, Medline Kit SKU DYNJ910947; 10) CV, Medline Kit SKU DYNJ911488.

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Medline Kit SKU CDS840393P, UDI/DI 10198459405266 (each) 40198459405267 (case), Lot Number 26FMA487; Medline Kit SKU CDS840393Q, UDI/DI 10198459791673 (each) 40198459791674 (case), Lot Number 26GMA017; Medline Kit SKU CDS980895W, UDI/DI 10198459123542 (each) 40198459123543 (case), Lot Number 25LMG706; Medline Kit SKU CDS981551G, UDI/DI 10198459275814 (each) 40198459275815 (case), Lot Number 25JBY147; Medline Kit SKU CDS981551G, UDI/DI 10198459275814 (each) 40198459275815 (case), Lot Number 25JBR361; Medline Kit SKU CDS982028W, UDI/DI 10198459385605 (each) 40198459385606 (case), Lot Number 25LMH727; Medline Kit SKU DYNJ906903F, UDI/DI 10198459504877 (each) 40198459504878 (case), Lot Number 25JME689; Medline Kit SKU DYNJ906904C, UDI/DI 10198459168499 (each) 40198459168490 (case), Lot Number 25JMF804; Medline Kit SKU DYNJ906904C, UDI/DI 10198459168499 (each) 40198459168490 (case), Lot Number 25IMG539; Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25LLA930; Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25LLA516; Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25LLA196; Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25KLA552; Medline Kit SKU DYNJ910947, UDI/DI 10198459208928 (each) 40198459208929 (case), Lot Number 25KBD555; Medline Kit SKU DYNJ910947, UDI/DI 10198459208928 (each) 40198459208929 (case), Lot Number 25JBS919; Medline Kit SKU DYNJ910947, UDI/DI 10198459208928 (each) 40198459208929 (case), Lot Number 25JBM122; Medline Kit SKU DYNJ911488, UDI/DI 10198459361616 (each) 40198459361617 (case), Lot Number 25KBF034.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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View official government recall

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