Hearth Record

Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063

Medical device recall Z-3041-2024. Published in FDA’s Enforcement Report on Sep 18, 2024.

FDA’s own record, on accessdata.fda.gov

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 Sep 18, 2024. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Number DYNDA2080; 3) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 4) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 5) ARTHROGRAM TRAY, Pack Number DYNDH1113; 6) ARTHROGRAM TRAY, Pack Number DYNDH1134; 7) BIOPSY TRAY, Pack Number DYNDH1137C; 8) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 9) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270; 10) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1275; 11) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 12) ISHAK IR DRAINAGE TRAY, Pack Number DYNDH1300; 13) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 14) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1321; 15) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324B; 16) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 17) LUMBAR TRAY, Pack Number DYNDH1500; 18) TRAY SAFETY LUMBAR PUNCTURE 18GX3.5, Pack Number DYNDH1538; 19) TRAY SAFETY LUMBAR PUNCTURE 20GX3.5, Pack Number DYNDH1539; 20) LUMBAR TRAY, Pack Number DYNDH1540; 21) LUMBAR TRAY, Pack Number DYNDH1540A; 22) BIOPSY PACK, Pack Number DYNDH1556B; 23) BIOPSY KIT, Pack Number DYNDH1570; 24) MYELOGRAM TRAY, Pack Number DYNDH1574; 25) BIOPSY BASIC PACK, Pack Number DYNDH1588; 26) BIOPSY TRAY, Pack Number DYNDH1693; 27) BIOPSY TRAY, Pack Number DYNDH1693A; 28) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1698; 29) BIOPSY PACK, Pack Number DYNDL1462B; 30) LACERATION TRAY, Pack Number DYNDL1774A; 31) LACERATION TRAY, Pack Number DYNDL1887; 32) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162; 33) LUMBAR EPIDURAL TRAY-LF, Pack Number DYNJRA0313B; 34) BIOPSY TRAY - LF, Pack Number DYNJTS0018A; 35) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 36) MYELOGRAM TRAY W/WATER SOLUBLE, Pack Number DYNJTS04035; 37) LUMBAR TRAY, Pack Number DYNJTS0422; 38) MYELOGRAM TRAY, Pack Number DYNJTS0514; 39) INFANT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS07025; 40) ADULT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4301; 41) INFANT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4302; 42) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 43) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS8100; 44) CENTRAL LINE INSERTION KIT W/16CM CATH, Pack Number ECVC7440A; 45) OB DELIVERY TRAY, Pack Number MNS10875; 46) OB DELIVERY TRAY, Pack Number MNS10875A; 47) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 48) BIOPSY TRAY, Pack Number P151659; 49) ARTHROGRAM PACK, Pack Number P241108; 50) ARTHROGRAM TRAY, Pack Number SPEC0004C; 51) RADIOLOGY PACK-LF, Pack Number SPEC0127; 52) ARTHROGRAM TRAY, Pack Number SPEC0143A; 53) BIOPSY TRAY, Pack Number SPEC0148; 54) RADIOLOGY/BIOPSY, Pack Number SPEC0149; 55) LUMBAR TRAY, Pack Number SPEC0177; 56) DR COPPEL FACET TRAY, Pack Number SPEC0178A; 57) BIOPSY TRAY W/O LIDOCAINE, Pack Number SPEC0196B; 58) LUMBAR TRAY, Pack Number SPEC0197D; 59) ARTHROGRAM TRAY, Pack Number SPEC0221A; 60) ARTHROGRAM TRAY, Pack Number SPEC0232; 61) 22G FACET TRAY, Pack Number SPEC0265A; 62) LUMBAR PUNCTURE TRAY, Pack Number SPEC0289; 63) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 64) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 65) BIOPSY TRAY-LF, Pack Number SPEC4380; 66) LACERATION TRAY, Pack Number SUT18080; 67) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 68) UMBILICAL VESSEL TRAY, Pack Number UVT1100A

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

DYNDA2063, Lot Number 2021111250; DYNDA2080, Lot Number 2019052290; DYNDA2495, Lot Number 2021040550; DYNDA2497, Lot Number 2022042650; DYNDH1113, Lot Number 2020022450; DYNDH1134, Lot Number 2021022250; DYNDH1137C, Lot Number 2021081990;…

Every code shown here, 1,994 characters

DYNDA2063, Lot Number 2021111250; DYNDA2080, Lot Number 2019052290; DYNDA2495, Lot Number 2021040550; DYNDA2497, Lot Number 2022042650; DYNDH1113, Lot Number 2020022450; DYNDH1134, Lot Number 2021022250; DYNDH1137C, Lot Number 2021081990; DYNDH1257, Lot Number 2019120650; DYNDH1257, Lot Number 2020060550; DYNDH1257, Lot Number 2021041550; DYNDH1270, Lot Number 2019040490; DYNDH1275, Lot Number 2019022090; DYNDH1275, Lot Number 2019050990; DYNDH1275, Lot Number 2019070390; DYNDH1275, Lot Number 2019081990; DYNDH1297, Lot Number 2022041250; DYNDH1300, Lot Number 2020060550; DYNDH1300, Lot Number 2022041250; DYNDH1319, Lot Number 2020012750; DYNDH1321, Lot Number 2019032290; DYNDH1324B, Lot Number 2022032950; DYNDH1359, Lot Number 2019040490; DYNDH1500, Lot Number 2020012750; DYNDH1500, Lot Number 2022031050; DYNDH1500, Lot Number 2022032950; DYNDH1538, Lot Number 2020070850; DYNDH1539, Lot Number 2020070850; DYNDH1539, Lot Number 2022042850; DYNDH1540, Lot Number 2020080750; DYNDH1540, Lot Number 2020100250; DYNDH1540A, Lot Number 2020110950; DYNDH1540A, Lot Number 2021042250; DYNDH1540A, Lot Number 2021070750; DYNDH1540A, Lot Number 2021091850; DYNDH1540A, Lot Number 2023050190; DYNDH1540A, Lot Number 2023061390; DYNDH1556B, Lot Number 2022031050; DYNDH1570, Lot Number 2021041350; DYNDH1570, Lot Number 2022032450; DYNDH1574, Lot Number 2022031450; DYNDH1588, Lot Number 2021021750; DYNDH1693, Lot Number 2021122050; DYNDH1693A, Lot Number 2022011150; DYNDH1698, Lot Number 2022022550; DYNDH1698, Lot Number 2022031650; DYNDH1698, Lot Number 2022040550; DYNDH1698, Lot Number 2022052550; DYNDH1698, Lot Number 2022060850; DYNDL1462B, Lot Number 2022042650; DYNDL1462B, Lot Number 2022050450; DYNDL1774A, Lot Number 2019040490; DYNDL1887, Lot Number 2019101890; DYNJ05162, Lot Number 2020022450; DYNJRA0313B, Lot Number 2019040490; DYNJRA0313B, Lot Number 2019053190; DYNJRA0313B, Lot Number 2019102390; DYNJTS0018A, Lot Number 2020071050; DYNJTS0214, Lot Number 2021022250;…

FDA’s list runs to 6,263 characters. The first part is shown; the rest is on FDA’s record.

Source:

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.

These words name no state.

The words say it went outside the United States too.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Apr 8, 2024.
  • FDA classified it on Sep 6, 2024.
  • FDA’s Enforcement Report published it on Sep 18, 2024.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • MEDLINE INDUSTRIES, LP - Northfield, 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.
Source:

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 6,263 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.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • 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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

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Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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