CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report
Medline Convenience kits containing Swan-Ganz Catheters Kit recalled
Medline Industries is recalling Medline Convenience kits containing Swan-Ganz Catheters Kit Germantown Cabg DYNJ905855, 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-2609-2026
- 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 KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B
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?
DYNJ905855 UDI-DI 10193489546606 Lots 21ABU297 21BBB235 21DBV520 21FBG162 21GBC672 21GBI192 21IBT387 21VBB580 22DBK812 22FBR093 22FBS035 22HBI628 22IBV291 22JBX729 22NBE430 23ABD954 23BBI465 23CBO951 23CBX474 23GBF721 DYNJ905857 UDI-DI 10193489545678 Lots 21ABG510 21GBK940 DYNJ905936B UDI-DI 10193489422818 Lots 21BBF766 21DBP452 21FBF248 21LBJ459 22ABV319 22DBS751 22FBU868
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 99209More recalls from Medline Industries
All 709| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Burgundy recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Blue recalled by Medline Industries | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |