CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report
Medline Convenience kits containing Swan-Ganz Catheters recalled
Medline Industries is recalling Medline Convenience kits containing Swan-Ganz Catheters Right Heart Cath Pack Ctx, distributed nationwide in the US. The recall was initiated on 28 May 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-2606-2026
- FDA event ID
- 99209
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 May 2026
- FDA classified
- 26 Jun 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 28 May 2026 | Recall initiated by company | |
| 26 Jun 2026 | Classified by FDA | +29 days |
| 8 Jul 2026 | Published in enforcement report | +12 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 Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B
Where it was distributed
US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Nationwide ArizonaCaliforniaFloridaIllinoisMissouriNew JerseyOhioOklahomaTennesseeTexasWisconsin
Questions about this recall
Why was it recalled?
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Which lots are affected?
UDI-DI 10195327345044 Lots 23DBI807 23FBG708 23GBK642 23KBO477 24BBG198 24FBN889 24GBJ879 24HBR045 24LBT492 25ABL957 25BBN572 25GBT734 25HBQ817 25LBM617 26BBK766 26DBE720
Where was it sold?
US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 99209This product is part of a recall event; the main page for the event is Medline Convenience kits containing Swan-Ganz Catheters Kit recalled.
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