Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B…
Medical device recall Z-1878-2026. Published in FDA’s Enforcement Report on Apr 29, 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 Apr 29, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 270,311 total 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?
Unapproved design changes to the products outside of the 510(k) clearance.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT PACK-LF DYNJ0842516G CATHETER PACK DYNJ61926 EP DRAPE PACK-LF DYNJ47645C EP PACK DYNJ47782G EPS ACCESSORY PACK DYNJT2201S H CLINIC VASCULAR PK DYNJ33415A HEART FAILURE PACK DYNJ64877B HYBRID PACK DYNJ65925D INTERVENTIONAL RAD PACK DYNJ44100M INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AG MV-PACEMAKER PACK-LF DYNJ41556F NEURO RADIOLOGY RICHMOND DYNJ68365D OR HYBRID-M DYNJ907758D, DYNJ907758F PACEMAKER DYNJ907960C PACEMAKER PACK DYNJ42557B DYNJ61411 DYNJ61411A DYNJ61411B DYNJ80160 PACER PACK DYNJ40952B PERIPHERAL ARTERIOGRAM RAD DYNJ61383B RADIOLOGY PACK DYNJ54762D TAVR PACK DYNJ55338B DYNJ69246A VASCULAR ACCESS TRAY DYNJ52606F VASCULAR TRAY DYNJ49802C VEIN PACK DYNJ57512 DYNJ58063 DYNJ84953
270,311 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
DYNJ69246B UDI-DI 10198459335266 (EA) 40198459335267 (CS) LOT 25EBM356 DYNJ905291D UDI-DI 10195327393090 (EA) 40195327393091 (CS) LOTS 24JBO127 24LBJ199 DYNJ86769 UDI-DI 10195327674168 (EA) 40195327674169 (CS) LOT 24EMF716 DYNJ26783D…
Every code shown here, 1,995 characters
DYNJ69246B UDI-DI 10198459335266 (EA) 40198459335267 (CS) LOT 25EBM356 DYNJ905291D UDI-DI 10195327393090 (EA) 40195327393091 (CS) LOTS 24JBO127 24LBJ199 DYNJ86769 UDI-DI 10195327674168 (EA) 40195327674169 (CS) LOT 24EMF716 DYNJ26783D UDI-DI 10193489616750 (EA) 40193489616751 (CS) LOTS 23DBJ248 23EBK921 23FBS130 23HBB516 23IBS065 23JBP123 23LBP196 24ABR004 24ABR121 24BBG855 24GBV377 24JBI914 24KBD153 24LBB665 DYNJ35615G UDI-DI 10195327099404 (EA) 40195327099405 (CS) LOT 23EBR748 DYNJ0842516G UDI-DI 10195327286392 (EA) 40195327286393 (CS) LOTS 24CDB991 24GDB891 24IDA796 24KDB683 DYNJ61926 UDI-DI 10193489610406 (EA) 40193489610407 (CS) LOTS 23CBK311 23DBM226 23FBP893 23GBN159 23HBC859 23JBH552 23LBV456 24DBM081 24EBS504 24FBR479 DYNJ47645C UDI-DI 10195327355173 (EA) 40195327355174 (CS) LOTS 23IMH312 23LMD467 24BMB620 24DMD512 24FMF757 24GMD538 24JMC369 24KMB831 24LMD945 DYNJ47782G UDI-DI 10195327495640 (EA) 40195327495641 (CS) LOT 24GMA622 DYNJT2201S UDI-DI 10195327263003 (EA) 40195327263004 (CS) LOT 23HMG629 DYNJ33415A UDI-DI 10888277792555 (EA) 40888277792556 (CS) LOT 24CBG963 DYNJ64877B UDI-DI 10193489415896 (EA) 40193489415897 (CS) LOTS 23CBF259 23HBM117 23HBO973 23KBD360 23LBG859 24ABB266 24CMJ034 24FMD963 24HMH185 24JMD105 DYNJ65925D UDI-DI 10195327531188 (EA) 40195327531189 (CS) LOT 24DLA029 DYNJ44100M UDI-DI 10195327324988 (EA) 40195327324989 (CS) LOTS 23IMG347 23JMI669 23LME170 24AMI085 24CMA877 24CMJ446 24DME309 24FMC387 24FMC900 24FMF012 24FMH007 24GMC363 24HMF632 24JMF664 24LMD487 DYNJ0516014AG UDI-DI 10195327271640 (EA) 40195327271641 (CS) LOTS 23BME190 23DMH005 23KMH805 23KMI253 23LMH275 24AMH347 24CMI868 24DMI402 24DMK427 24EMG633 24IMB650 24IMJ127 24KMC298 DYNJ41556F UDI-DI 10193489968170 (EA) 40193489968171 (CS) LOTS 23IME423 23IMH983 DYNJ68365D UDI-DI 10195327525040 (EA) 40195327525041 (CS) LOT 23JBH517 DYNJ907758D UDI-DI 10195327351335 (EA) 40195327351336 (CS) LOTS 23FBP055 23HBC362 23HBL227 23HBX060 23KBB106 24CBT278 24CBV291 24HBE808 24HBR182…
FDA’s list runs to 5,091 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.
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
These words name no state.
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.
The words say it went outside the United States too.
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 Feb 27, 2026.
- FDA classified it on Apr 17, 2026.
- FDA’s Enforcement Report published it on Apr 29, 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: Letter.
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 5,091 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.