Class II U.S. Food and Drug Administration

Medline convenience kits labeled as: 1) Open Heart Pack recall: Kits contain a potentially contaminated component which were recalled

Recall published last month

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

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Kits contain a potentially contaminated component which were recalled by the manufacturer

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3020-2026
Published
September 2, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
263 kits
Distribution
Nationwide
Made in
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.
UPC codes
10198459405266, 40198459405267, 10198459791673, 40198459791674, 10198459123542, 40198459123543, 10198459275814, 40198459275815, 10198459385605, 40198459385606, 10198459504877, 40198459504878, 10198459168499, 40198459168490, 10198459308581, 40198459308582, 10198459208928, 40198459208929, 10198459361616, 40198459361617

Products covered by this recall

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.

Check your product

The notice names 57 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10198459405266
  • 40198459405267
  • 10198459791673
  • 40198459791674
  • 10198459123542
  • 40198459123543
  • 10198459275814
  • 40198459275815
  • 10198459385605
  • 40198459385606
  • 10198459504877
  • 40198459504878
  • 10198459168499
  • 40198459168490
  • 10198459308581
  • 40198459308582
  • 10198459208928
  • 40198459208929
  • 10198459361616
  • 40198459361617

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 26FMA487
  • 26GMA017
  • 25LMG706
  • 25JBY147
  • 25JBR361
  • 25LMH727
  • 25JME689
  • 25JMF804
  • 25IMG539
  • 25LLA930
  • 25LLA516
  • 25LLA196
  • 25KLA552
  • 25KBD555
  • 25JBS919
  • 25JBM122
  • 25KBF034. — 263 kits

Model or item number

On the rating label, the box or the instruction sheet.

  • CDS840393P
  • CDS840393Q
  • CDS980895W
  • CDS981551G
  • CDS982028W
  • DYNJ906903F
  • DYNJ906904C
  • LL BASE
  • Medline Kit SKU DYNJ908362F
  • DYNJ910947
  • UDI
  • DI 10
  • DI 10198459791673
  • DI 10198459123542
  • DI 10198459275814
  • DI 10198459385605
  • DI 10198459504877
  • DI 10198459168499
  • DYNJ908362F
  • DI 10198459308581

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10198459405266, 40198459405267, 10198459791673; lot code 26FMA487, 26GMA017, 25LMG706; model number CDS840393P, CDS840393Q, CDS980895W. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls