Medline Industries recall: Medline Convenience Kit: OPEN HEART A PACK
Medline Industries, LP is recalling Medline Convenience Kit: OPEN HEART A PACK because of a sterility problem – 135 units. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on July 23, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Medline Convenience Kit: OPEN HEART A PACK |
| Brand | Medline Industries |
| Company | Medline Industries, LP |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 23, 2026 |
| Published by FDA | September 23, 2026 |
| Quantity | 135 units |
| Recall ID | 99583 |
Recalled products
- Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
- FDA recall number
- Z-3137-2026
- Codes, lots and dates
- UDI-DI: 10198459445941 (each), 40198459445942 (case); Lot Numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372
- Quantity
- 135 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99583
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Northfield, IL, United States
Why it was recalled
The problem: a sterility problem.
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution in the state of CA.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99583, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Medline Industries recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 total | a fire hazard Most serious | FDA Class I |
| Sep 30, 2026 | Medline Industries recall: Medline Convenience Kits: 1) PEDS SINUS PACK and 4 more productsMedical devices · 695 kits; 128 kits; 486 kits; 234 kits; 4013 kits | The kits contain neurological sponges with the potential for unexpected variability of end… Serious | FDA Class II |
| Sep 30, 2026 | Medline Industries recall: Medline convenience kits containing Healthmark Instrument Channel BrushesMedical devices · 90 kits (US) | Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacture… Serious | FDA Class II |
| Sep 23, 2026 | Medline Industries recall: Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET and 6 more productsMedical devices · 12 kits; 489 kits; 447 kits; 10407 kits; 2718 kits; 1100 kits; 47848 kits | The kits contain certain lots of sterile applicators which may contain fungal contaminatio… Most serious | FDA Class I |
| Sep 23, 2026 | Medline Industries recall: Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A and 3 more productsMedical devices · 341; 459; 60; 336 | a sterility problem Serious | FDA Class II |
| Sep 9, 2026 | Medline Industries recall: Medline Convenience Kits containing BD ChloraPrep ClearMedical devices · 222,653 total | Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that wer… Serious | FDA Class II |
| Sep 9, 2026 | Medline Industries recall: Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT and 15 more productsMedical devices · 104 kits; 4636 kits; 58037 kits; 17,750 kits; 176 kits; 300 kits; 434,595 kits; 1840 kits; 22736 Kits; 3650 kits; 13032 kits; 3752 kits; 352 kits; 2080 kits; 18290 kits; 996692 kits | a sterility problem Serious | FDA Class II |
| Sep 2, 2026 | Medline Industries recall: Medline medical convenience kit labeled as: TRACH TUBE KITMedical devices · 45 kits | Component labeling discrepancy Serious | FDA Class II |
| Sep 2, 2026 | Medline Industries recall: Medline medical convenience kitsMedical devices · 2262 kits; 246 kits; 3468 kits; 974 kits | Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neuros… Serious | FDA Class II |
| Sep 2, 2026 | Medline Industries recall: Medline Hudson RCI and 2 more productsMedical devices · 20 units; 145525 units; 271406 units | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The he… Serious | FDA Class II |
| Sep 2, 2026 | Medline Industries recall: Medline convenience kits labeled as: 1) FEMORAL PACK and 10 more productsMedical devices · 71 kits; 263 kits; 24 kits; 94 kits; 15 kits; 663 kits; 1349 kits; 106 kits; 169 kits; 419 kits; 241 kits | Kits contain a potentially contaminated component which were recalled by the manufacturer Serious | FDA Class II |
| Aug 19, 2026 | Medline Industries recall: Medline Micro-Kill Bleach Germicidal Bleach WipesMedical devices · 591,561 units; 447,618 units; 1,244 units; 31,728 | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concen… Serious | FDA Class II |
All 13 Medline Industries recalls →
About this recall
Is Medline Industries Medline Convenience Kit: OPEN HEART A PACK recalled?
Yes. Medline Industries, LP recalled it on July 23, 2026; FDA published it September 23, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Because of a sterility problem. The reason given: 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 …
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.