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 Cardiac Major DYNJ901328G Heart A, 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-2607-2026
- 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
- Lead & Heavy Metals
- 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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N
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
Is Medline Convenience kits containing Swan-Ganz Catheters Cardiac Major DYNJ901328G Heart A recalled?
Yes. Medline Industries recalled Medline Convenience kits containing Swan-Ganz Catheters Cardiac Major DYNJ901328G Heart A on 28 May 2026. The recall is Class II and its status is Ongoing. Recall number Z-2607-2026.
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?
DYNJ901328G UDI-DI 10198459601538 Lots 26ABD786 26CBD768 26DBJ434 DYNJ903465K UDI-DI 10198459292743 Lots 25GDB257 26ADA464 26BDA587 26DDA021 DYNJ909090G UDI-DI 10198459406027 Lots 25LBH690 25LBP697 DYNJ906102M UDI-DI 10198459406409 Lots 25JBE315 25KBI700 25KBM827 25LBB028 26ABH106 26CBQ206 DYNJ902664M UDI-DI 10198459349126 Lots 25ILA177 25KLA500 DYNJ902664N UDI-DI 10198459675287 Lot 26BLA783
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 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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