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Medline Convenience Kits Recall Over Potentially Contaminated Component

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Medline Industries, LP is recalling 263 convenience kits distributed nationwide because they contain a potentially contaminated component recalled by the manufacturer.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on September 10, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Kits contain a potentially contaminated component which were recalled by the manufacturer", distributed 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.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.

What Happened

Medline Industries, LP initiated a voluntary recall of certain convenience kits after determining that the kits contain a potentially contaminated component which were recalled by the manufacturer. The recall is classified as Class II and remains ongoing.

Which Products Are Affected

The recall affects 263 kits distributed to US Nationwide in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI. Affected products include:

  1. OPEN HEART PACK, Medline Kit SKU CDS840393P, UDI/DI 10198459405266 (each) 40198459405267 (case), Lot Number 26FMA487
  2. OPEN HEART PACK, Medline Kit SKU CDS840393Q, UDI/DI 10198459791673 (each) 40198459791674 (case), Lot Number 26GMA017
  3. OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W, UDI/DI 10198459123542 (each) 40198459123543 (case), Lot Number 25LMG706
  4. VALVE CDS, Medline Kit SKU CDS981551G, UDI/DI 10198459275814 (each) 40198459275815 (case), Lot Number 25JBY147
  5. VALVE CDS, Medline Kit SKU CDS981551G, UDI/DI 10198459275814 (each) 40198459275815 (case), Lot Number 25JBR361
  6. FEM POP, Medline Kit SKU CDS982028W, UDI/DI 10198459385605 (each) 40198459385606 (case), Lot Number 25LMH727
  7. PACK,OPEN HEART, Medline Kit SKU DYNJ906903F, UDI/DI 10198459504877 (each) 40198459504878 (case), Lot Number 25JME689
  8. PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C, UDI/DI 10198459168499 (each) 40198459168490 (case), Lot Number 25JMF804
  9. PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C, UDI/DI 10198459168499 (each) 40198459168490 (case), Lot Number 25IMG539
  10. ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25LLA930
  11. ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25LLA516
  12. ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25LLA196
  13. ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25KLA552
  14. OPEN HEART, Medline Kit SKU DYNJ910947, UDI/DI 10198459208928 (each) 40198459208929 (case), Lot Number 25KBD555
  15. OPEN HEART, Medline Kit SKU DYNJ910947, UDI/DI 10198459208928 (each) 40198459208929 (case), Lot Number 25JBS919
  16. OPEN HEART, Medline Kit SKU DYNJ910947, UDI/DI 10198459208928 (each) 40198459208929 (case), Lot Number 25JBM122
  17. CV, Medline Kit SKU DYNJ911488, UDI/DI 10198459361616 (each) 40198459361617 (case), Lot Number 25KBF034

Recall number Z-3020-2026. Recall initiation date: 20260710.

What You Should Do

Consumers in possession of the affected kits should follow instructions provided by Medline Industries, LP regarding the recalled component.

Why This Matters

This Class II recall involves 263 kits distributed across multiple states and addresses potential contamination in surgical convenience kits.

Source

FDA recall number Z-3020-2026, https://www.fda.gov

Original source: FDA Official Notice ↗

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Similar body length

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Similar severity timing

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about? ▾
Medline Industries, LP is recalling 263 convenience kits distributed nationwide because they contain a potentially contaminated component recalled by the manufacturer.
Which agency issued this alert? ▾
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter? ▾
The FDA classifies this as a Class II recall, citing "Kits contain a potentially contaminated component which were recalled by the manufacturer" as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected? ▾
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates? ▾
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.

Primary source data

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