Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M…
Medical device recall Z-2613-2026. Published in FDA’s Enforcement Report on Jul 8, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 8, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 11 states named
- 9,272 kits how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
9,272 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,997 characters
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 23EBR134 23FBM591 23FBS624 23HBU190 24FBG082 24GBE581 24HBM636 24IBS825 24JBV903 24KBU708 24LBU110 25BBG391 25CBJ747 25DBP832 CDS981161AA UDI-DI 10193489303407 Lots 21DBH590 21DBU485 CDS981161AB UDI-DI 10193489817461 Lots 21DBT869 21FBD406 21FBK899 21HBT158 21IBJ277 21IBW875 22BBA363 22DBH285 22DBT988 22HBO231 22HBT037 22JBT785 DYNJ905437A UDI-DI 10193489571905 Lots 21ABH889 21DBE110 21EBH610 DYNJ909090 UDI-DI 10195327268350 Lot 23EBD437 DYNJ909090C UDI-DI 10198459084768 Lots 24HBR121 24KBT550 DYNJ9855016R UDI-DI 10193489481730 Lot 21DKA468 DYNJ9855016S UDI-DI 10193489904659 Lots 21HBC511 21HBC512 22GBZ353 22JBA413 22OBI292 22OBL745 23BBA924 23BBN806 23CBM193 CDS984289J UDI-DI 10193489263046 Lots 21BKA389 21DKA676 21FLA954 21GLA057 21GLA312 21GLB087 21HLA680 21ILA628 21KLB205 CDS983849D UDI-DI…
FDA’s list runs to 4,481 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
The states and territories these words name
- Arizona
- California
- Florida
- Illinois
- Missouri
- New Jersey
- Ohio
- Oklahoma
- Tennessee
- Texas
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 28, 2026.
- FDA classified it on Jun 26, 2026.
- FDA’s Enforcement Report published it on Jul 8, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medline Industries, LP, of Northfield, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,481 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.