CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report
Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled
Medline Industries is recalling Medline convenience kits labeled as: Open Heart Pack, Medline Kit, distributed nationwide in the US. The recall was initiated on 10 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3020-2026
- FDA event ID
- 99507
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jul 2026
- FDA classified
- 26 Aug 2026
- Reported
- 2 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 10 Jul 2026 | Recall initiated by company | |
| 26 Aug 2026 | Classified by FDA | +47 days |
| 2 Sep 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Kits contain a potentially contaminated component which were recalled by the manufacturer
Product as listed by the FDA
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.
Where it was 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.
Nationwide AlabamaCaliforniaFloridaIllinoisKansasLouisianaMassachusettsMarylandMissouriMississippiMontanaNevadaNew YorkOhioOklahomaSouth CarolinaTexasWisconsin
Questions about this recall
Is Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled?
Yes. Medline Industries recalled Medline convenience kits labeled as: Open Heart Pack, Medline Kit on 10 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-3020-2026.
Why was it recalled?
Kits contain a potentially contaminated component which were recalled by the manufacturer
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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