Fresh Recalls

FDAClass II · Medical device · Recall Z-3020-2026 · Recalled September 2, 2026

Medline convenience kits labeled as recall — Medline Industries, LP

Agency report date: September 2, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Medline convenience kits labeled as
Company / brand
Medline Industries
Lot / serial / date codes
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.
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.
Agency product description and boundaries

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.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Medline convenience kits labeled as recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-3020-2026
Brand
All Medline Industries recalls
Classification
Class II
Units affected
263 kits
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Northfield, IL, United States
Firm address
3 Lakes Dr, N/A, 60093-2753

Identifying details (verbatim from the notice)

Product codes / lots
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.
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.
Firm notified the public via
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID
99507
Recall initiated
July 10, 2026
FDA classified
August 26, 2026
FDA report date
September 2, 2026

More Medline Industries recalls

Other medical device recalls from around the same time

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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