Recall Z-2613-2026
Medline Industries, LP · initiated May 28, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465F DYNJ903465G HEART TRAY-VASCULAR DYNJ907857 DYNJ907857A DYNJ907857B KIT UNIVERSITY CABG PK DYNJ905857A OPEN HEART CDS981161AA CDS981161AB DYNJ905437A DYNJ909090 DYNJ909090C DYNJ9855016R DYNJ9855016S OPEN HEART ACCESSORY CDS CDS984289J OPEN HEART ANESTHESIA PACK CDS983849D CDS983849F CDS983849G OPEN HEART B CDS DYNJ900377P OPEN HEART BASIC B DYNJ904311C OPEN HEART CDS CDS983513F OPEN HEART CDS QVH CDS982523K CDS982523L CDS982523N OPEN HEART LINE SET UP DYNJ908179 DYNJ908179A OPEN HEART SUPPLEMENT DYNJ909116 DYNJ909116A DYNJ909116C DYNJ909116D SILVER CROSS OPEN HEART DYNJ906102J DYNJ906102K DYNJ906102L SM OPEN HEART PACK A&B DYNJ904749G DYNJ904749J VPH OPEN HEART DYNJ902664J DYNJ902664K DYNJ902664L
Codes / lots: CDS982269K UDI-DI 10193489906844 Lots 21HBN691 21JBQ518 21LBD444 CDS982269L UDI-DI 10195327018016 Lots 21LBP501 22ABR514 22BBE936 22FBV989 CDS982269M UDI-DI 10195327192808 Lots 22JBE028 22LBF124 23ABP909 23CBO580 CDS982269N UDI-DI 10195327352998 Lots 23GBC969 23HBS959 23KBW067 23LBF510 24CBO691 24DBR250 24EBU619 24GBF288 25ABM339 25CBJ666 25HBH657 25IBM477 26BBG451 DYNJ901328D UDI-DI 10193489854923 Lots 21CBQ397 21FBJ935 21HBR220 21JBV897 21JBV898 22ABG611 DYNJ901328F UDI-DI 10195327044572 Lots 22CBX749 22FBX103 23ABC195 23EBG860 23EBL637 23EBS968 23FBM688 23GBS043 24EBL355 24FBJ301 24IBS567 24JBD767 24JBU518 24KBL806 24LBF815 25DBF590 25FBQ740 25GBH267 25JBQ634 DYNJ903465F UDI-DI 10193489918397 Lots 21FDB453 21HDB016 21IDB927 21KDA273 21LDA283 21LDB750 22CDA262 DYNJ903465G UDI-DI 10195327175559 Lots 22FDA593 22IDA677 22KDA077 23ADB246 DYNJ907857 UDI-DI 10193489909364 Lots 21GBJ159 21IBX945 21LBJ320 22ABH627 DYNJ907857A UDI-DI 10195327133160 Lots 22HBK592 22KBM436 DYNJ907857B UDI-DI 10195327256869 Lots 22KBN208 23ABM669 23IBE277 DYNJ905857A UDI-DI 10193489946680 Lots 22CBW896 22DBR508 22GBG113 22GBW887 22IBU528 22JBA758 22KBJ132 23ABP277 23ABP278 23ABS778 23DBD840 23EBJ932…
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.
FDA-determined cause: Process change control
Action taken
On May 28, 2026, the firm notified customers via letters titled "URGENT MEDICAL DEVICE CORRECTION." Customers were referred to BD's recall notice, which provides advice for users and instructions to mitigate hub breakage issues. Product return is not required. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-2613-2026
- Initiated
- May 28, 2026
- Posted by FDA
- June 26, 2026
- Product code
- OEZ – Cardiovascular Procedure Kit
- Quantity
- 9,272 kits
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2606-2026 Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… | 05/28/2026Open, Classified |
| Z-2607-2026 Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… | 05/28/2026Open, Classified |
| Z-2608-2026 Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… | 05/28/2026Open, Classified |
| Z-2609-2026 Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… | 05/28/2026Open, Classified |
| Z-2610-2026 Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… | 05/28/2026Open, Classified |
| Z-2611-2026 Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… | 05/28/2026Open, Classified |
| Z-2612-2026 Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… | 05/28/2026Open, Classified |