1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I
Medical device recall Z-0169-2027. Published in FDA’s Enforcement Report on Oct 21, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 21, 2026. Copied from openFDA on Oct 27, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1834 kits how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
FDA, Device recall enforcement reports. Released Oct 27, 2026. Updated weekly.
Which ones are recalled?
1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528O; 4) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528P; 5) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312J; 6) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312K; 7) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ43937; 8) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ80549D; 9) Product Name CV PART 1 AND 2, Medline Kit Number/SKU DYNJ908879; 10) Product Name CV PART 1 AND 2, Medline Kit Number/SKU DYNJ908879C; 11) Product Name CARDIAC SURGERY, Medline Kit Number/SKU DYNJ911589A; 12) Product Name AV SHUNT-MARYVIEW, Medline Kit Number/SKU DYNJ911710; 13) Product Name CARDIAC ACCESSORY PACK, Medline Kit Number/SKU DYNJT7607.
1834 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 27, 2026. Updated weekly.
Codes to check against yours
Medline product number/SKU DYNJ911589A, UDI/DI 10198459646102 (each) 40198459646103 (case), Lot Number 26CBD487; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 26BLA622; Medline…
Every code shown here, 1,999 characters
Medline product number/SKU DYNJ911589A, UDI/DI 10198459646102 (each) 40198459646103 (case), Lot Number 26CBD487; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 26BLA622; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 26ADA368; Medline product number/SKU DYNJT7607, UDI/DI 10198459639470 (each) 40198459639471 (case), Lot Number 26ABP608; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 25KLA755; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25KDA055; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 25JLA081; Medline product number/SKU DYNJ80549D, UDI/DI 10198459389610 (each) 40198459389611 (case), Lot Number 25JBQ932; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25IDA242; Medline product number/SKU DYNJ80549D, UDI/DI 10198459389610 (each) 40198459389611 (case), Lot Number 25HBV035; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25ELA868; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25EDA603; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25BLA807; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25BLA545; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25ALA107; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24LDA717; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24LDA627; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot…
FDA’s list runs to 7,161 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 2, 2026.
- FDA classified it on Oct 15, 2026.
- FDA’s Enforcement Report published it on Oct 21, 2026.
FDA, Device recall enforcement reports. Released Oct 27, 2026. Updated weekly.
Who is recalling it?
- Medline Industries, LP, of Northfield, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 27, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 7,161 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 27, 2026 and checked Oct 27, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 27, 2026.