Non-sterile convenience kits: a
Medical device recall Z-2232-2024. Published in FDA’s Enforcement Report on Jul 10, 2024.
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 10, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 23 states named
- 7,673 total non-sterile 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?
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2 Adult Kit, Pack ACC010365A, containing a Pure Pouch component DYNJ04048, Kelly Forceps/STD STR Sterile. c. Medline Code Cart Drawer 2 Adlt Peds, Pack #ACC010366A, containing a Pure Pouch component DYNJ04048, Kelly Forceps/STD STR Sterile. d. Medline Drawer 2, Pack #ACC010375A, containing a Pure Pouch component Reorder #TRI67630, Sterile Straight Mayo Scissors, 5.5” and Sterile Magill Forceps, Reorder #66790. e. Medline Adult Drawer 4, Pack #ACC010389C, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. f. Medline Code Cart Drawer 1 Adult Airwa, Pack #ACC010451A, containing a Pure Pouch component Sterile Magill Forceps, Reorder #66790. g. Medline Emergency Airway Drawer, Pack #ACC010492, containing a Pure Pouch component Sterile Magill Forceps, Reorder #66790. h. Medline Drawer 2, Pack #ACC010681, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile and Sterile Magill Forceps, Reorder #66790. i. Medline Drawer 2, Pack #ACC010690, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. j. Medline Drawer Two #IMF 109694, Pack #ACCVB1000A, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. k. Medline First Hlth Moore Bronchoscopy, Pack #DYK1015098B4, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. l. Medline Trunk Kit 1EA, Pack #DYKM2013A, containing a Pure Pouch component #DYNJ04048, Kelly Forceps/STD STR Sterile. m. Medline Difficult Kit, Pack #DYKM2135, containing a Pure Pouch component Sterile Curved Kelly Hemostat, Reorder #66175 and Sterile Magill Forceps, Reorder #66790. n. Medline Wound Care Kit, Pack #DYNDW1033B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile.
7,673 total non-sterile kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a. Pack #ACC010254B - Lot numbers 23KDB117, exp. 11/3/2024, and 23GDC173, exp. 6/30/2024, UDI-DI each-10193489651683 and UDI-DI case-40193489651684. b. Pack ACC010365A - Lot number23EDA386, exp. 12/31/2024, UDI-DI each 10195327063245 and…
Every code shown here, 1,996 characters
a. Pack #ACC010254B - Lot numbers 23KDB117, exp. 11/3/2024, and 23GDC173, exp. 6/30/2024, UDI-DI each-10193489651683 and UDI-DI case-40193489651684. b. Pack ACC010365A - Lot number23EDA386, exp. 12/31/2024, UDI-DI each 10195327063245 and UDI-DI case-40195327063246. c. Pack #ACC010366A - Lot number 23EDB861, exp. 1/31/2024, UDI-DI each 10195327063252 and UDI-DI case 40195327063253. d. Pack #ACC010375A - Lot numbers 23LDB985, exp. 6/30/2025; 23HDB243, exp. 3/31/2024, UDI-DI each-10193489890983 and UDI-DI case-40193489890984. e. Pack #ACC010389C - Lot numbers 24ADB277, exp. 3/31/2025; 23LDA035, exp. 3/31/2025; and 23HDC448, exp. 6/30/2024, UDI-DI each 10193489472493 and UDI-DI case-40193489472494. f. Pack #ACC010451A - Lot number 23HDB718, exp. 3/31/2025, UDI-DI each 10193489844849 and UDI-DI case 40193489844840. g. Pack #ACC010492 - Lot numbers 23IDA433, exp. 6/30/2024; 23HDC689, exp. 6/30/2024; and 23HDA419, exp. 5/30/2024; UDI-DI each-10193489481983 and UDI-DI case 40193489481984. h. Pack #ACC010681 - Lot numbers 24ADA608, exp. 7/31/2025; and 23HDB308, exp. 6/30/2025, UDI-DI each 10195327399665 and UDI-DI case-40195327399666. i. Pack #ACC010690 - Lot number 23IDB053, exp. 6/30/2024, UDI-DI each 10195327433307 and UDI-DI case-40195327433308. j. Pack #ACCVB1000A - Lot numbers 24ADB906, exp. 12/31/2024; 23KDC115, exp. 2/28/2025; 23IDB740, exp. 6/30/2024; and 23EDA442, ex. 5/31/2024; UDI-DI each-10195327345884 and UDI-DI case-40195327345885. k. Pack #DYK1015098B4 - Lot numbers 23IBA570, exp. 8/31/2026, and 23GBP526, exp. 8/31/2026, UDI-DI each 10884389250853 and UDI-DI case 40884389250854. l. Pack #DYKM2013A - Lot numbers 23KBH011, 23IBJ540, 23HBP844, 23HBE308, 23GBT102, and 23FBS539, all with exp. dates of 7/31/2024, UDI-DI each-10195327419868 and UDI-DI case-40195327419869. m. Pack #DYKM2135 - Lot numbers 24ABP810, 23EBJ055, and 23DBH351, all with exp. dates of 8/31/2025, UDI-DI each-10195327075798 and UDI-DI case-40195327075799. n. Pack #DYNDW1033B - Lot numbers…
FDA’s list runs to 2,136 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 AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.
The states and territories these words name
23 states and territories.
Every one of them
- Alabama
- California
- Colorado
- Connecticut
- Florida
- Illinois
- Indiana
- Maryland
- Minnesota
- Montana
- North Carolina
- New Jersey
- Nevada
- New York
- Ohio
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Virginia
- Washington
- Wisconsin
- Wyoming
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 Mar 14, 2024.
- FDA classified it on Jun 28, 2024.
- FDA’s Enforcement Report published it on Jul 10, 2024.
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: 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 2,136 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
-
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.