Use cautionMedical device recall · FDA · Published July 23, 2026
Medline Convenience Kit: Risk of Infection from Compromised Sterile Seal
Medline recalls convenience kits with potential sterile barrier breaches causing infection risks. Affected kits may cause infections or complications if used after seal compromise.
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device, including hemolysis, foreign body reaction, thromboembolism, and/or organ dysfunction.
“Medline Convenience Kit: Risk of Infection from Compromised Sterile Seal.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/1134698-medline-convenience-kit-risk-of-infection-from-compromised-sterile-seal. Based on FDA recall #Z-3137-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3137-2026%22&limit=1).
The FDA announced on July 23, 2026, that Medline Industries, LP is recalling the Medline Convenience Kit: OPEN HEART A PACK (Product Number DYNJ43008N) due to a potential sterile barrier breach. This defect risks infection or other complications if the non-sterile cannula is used.
How to tell if you have it
Brand: Medline
Product: Medline Convenience Kit: OPEN HEART A PACK
Lot Numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372
Distribution: US Nationwide distribution in the state of CA.
Units affected: 135
The hazard
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae with a potential sterile barrier breach, meaning sterility cannot be assured. If used without identifying a compromised pouch seal, there is a risk of infection or complications including hemolysis, foreign body reaction, thromboembolism, and/or organ dysfunction.
Context
GovInfoNow's records show Medline Industries, LP has issued 68 other recalls since July 31, 2025. Recent Medline recalls include a fungal contamination risk in Convenience Kits announced on August 11, 2026, and cut risks from Sinus Packs with sharp brush edges recalled on August 10, 2026. Other recent recalls of similar products include Medical Action Industries Blood Culture Kits Risk Localized Infection Due to Packaging Seal (July 23, 2026), Cardinal Health Presource Convenience Kits Recall: Contaminated Applicators Risk Infection (August 10, 2026), and AVID Medical Halyard IV Start Kit Non-Sterile Recall: Risk of Contamination (July 14, 2026).
How to tell if you have this one
Check for product number DYNJ43008N on the kit. Lot numbers 25HLA462, 25HLA916, 25JLA847, 25LLA298, or 26CLA372 indicate affected units.
Brand
Medline
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Seal
Inspect the pouch seal for any signs of damage or compromise before use.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3137-2026 (July 23, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3137-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.