Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS
Medical device recall Z-1111-2024. Published in FDA’s Enforcement Report on Mar 6, 2024.
- FDA Class I
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 Mar 6, 2024. Copied from openFDA on Oct 24, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 26171 units 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Which ones are recalled?
Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE1840; g) BRONCHOSCOPY PACK, REF DYNJ37775F; h) BRONCHOSCOPY TRAY, REF DYNDL1350A; i) BRONCHOSCOPY TRAY, REF DYNDL1350AH; j) CAP CHANGE LARGE KIT, REF DYNDA2277A; k) CAP CHANGE LARGE KIT, REF DYNDA2277B; l) DAILY VAD DRIVELINE KIT, REF DYNDC3006; m) DAILY VENT KIT, REF DYNDJ1076; n) DIALYSIS OFF KIT, REF DT21230A; o) DIALYSIS OFF KIT, REF DT20350B; p) DIALYSIS ON KIT, REF DT20355B; q) DOUBLE HUB/CAP CHANGE KIT, REF DYNDC2843; r) DR D CUSTOM PACK, REF DYNJ68068A; s) DR D CUSTOM PACK, REF DYNJ68068B; t) DUODENUM CULTURING PACK, REF DYNJ51294; u) EGD SOUTHEASTERN REG KIT, REF DYKE1830; v) EMERGENCY UMBILICAL INSERTION, REF UVT1165; w) ENDO KIT, REF DYKE1069B; x) ENDO KIT, REF DYKE1475B; y) ERCP ENDO KIT, REF P604360B; z) ERCP SOUTHEASTERN REG KIT, REF DYKM2127; aa) FACIAL PLASTY PACK, REF DYNJ55335D; bb) FIRST YEAR KIT LF, REF EDUC1037; cc) FOLEY BULB INDUCTION KIT, REF MNS13545; dd) G BUNDLE CDS, REF CDS982759; ee) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330B; ff) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330C; gg) GENERAL/HERNIA PACK, REF DYNJ38541B; hh) GI BRONCHOSCOPY KIT, REF DYKE1254C; ii) HH CAR STOCK IN BIN, REF DYKM1883; jj) IMMERSION 4, REF EDUC05059A; kk) KIT LINE INSERTION, REF CVI4730; ll) KIT, PEG, SOUTHEASTERN REG, REF DYKM2128; mm) LINE INSERT PACK, REF PHS422216004C; nn) MANUAL BLADDER IRRIGATION KIT, REF UROT1051; oo) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051A; pp) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051AH; qq) MOHS KIT, REF DYNDA2072A; rr) MULTI LUMEN CAP CHANGE, REF DYNDA2390A; ss) N HOME CARE WOUND KIT, REF DYK1188079W; tt) NURSE KIT NO LOGO-LF, REF EDUC05036; uu) NURSE TOTE, REF DYKM1872A; vv) NURSING SKILLS, REF EDUC05015A; ww) PICC, REF CDS980470D; xx) PRE OP KIT, REF DYKS1262A; yy) PULMONARY SETUP KIT, REF DYNDA2648; zz) PULMONARY SETUP KIT, REF DYNDA2648H; aaa) REDDY JOINT BATH, REF MMJB001; bbb) REDDY JOINT BATH, REF MMJB001A; ccc) RNSG 1441, REF EDUC1029; ddd) RNSG 1441, REF EDUC1029H; eee) RNSG 2201, REF EDUC1034; fff) RNSG 2201, REF EDUC1034H; ggg) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; hhh) SHEATH REMOVAL TRAY, REF DYNDC1311C; iii) SHORT TERM KIT, REF DYNDC3092; jjj) SINGLE HUB/CAP CHANGE KIT, REF DYNDC2841; kkk) STERILE CAP CHANGE, REF DYNDA2387A; lll) STERILE PREP KIT, REF DYNDA1359; mmm) STERILE PREP KIT, REF DYNDA1359A; nnn) STRL EK SINGLE PACK, REF DYNDA1360B; ooo) SUB PORT ACCESS TRAY, REF DYNDC2768A; ppp) SUPRA PUBIC IRRIGATION TRAY ST, REF DYNDT1019; qqq) SURGICAL PREP KIT, REF DYNJ46340B; rrr) SUTURE KIT, REF M101494; sss) SUTURE TRAY, REF DYNDS1085A; ttt) TRUNK KIT, REF DYKTRUNK1; uuu) TRUNK KIT 1EA, REF DYKM2013; vvv) UMBILICAL VESSEL INSERTION, REF DYNDA3011; www) URINALYSIS KIT, REF DYKM1251; xxx) VAD ACCESS CHANGE KIT, REF DYNDC2882B; yyy) VAD DRESSING KIT A, REF DYNDA2164; zzz) CENTRAL BLOOD CULTURE KIT, REF DYNDH1342B; aaaa) CVC DRESSING CHANGE KIT, REF EBSI1552; bbbb) PORT ACCESS POWER LOC KIT, REF DYNDC1712B; cccc) PORT ACCESS TRAY, REF DYNDC1128B;
26171 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Codes to check against yours
a) REF DYNJ55960G, UDI/DI 40193489917827 (case), 10193489917826 (unit), Lot Numbers: 23ALA126; b) REF DYNJ53643C, UDI/DI 40889942615354 (case), 10889942615353 (unit), Lot Numbers: 22CLA226, 22ELA033, 22GLA633, 22JLA774, 23BLA613, 23ELA554,…
Every code shown here, 1,992 characters
a) REF DYNJ55960G, UDI/DI 40193489917827 (case), 10193489917826 (unit), Lot Numbers: 23ALA126; b) REF DYNJ53643C, UDI/DI 40889942615354 (case), 10889942615353 (unit), Lot Numbers: 22CLA226, 22ELA033, 22GLA633, 22JLA774, 23BLA613, 23ELA554, 23FLA005; c) REF DYKM1880, UDI/DI 40193489807524 (case), 10193489807523 (unit), Lot Numbers: 22FLA285, 23FLA657, 23HLA920; d) REF DYKE1601, UDI/DI 40889942956082 (case), 10889942956081 (unit), Lot Numbers: 23ABG889, 23BBN595, 23BBU202, 23FBA860, 23HBI592; e) REF DYNDH1242, UDI/DI 40889942598138 (case), 10889942598137 (unit), Lot Numbers: 22GLA574, 22KLA372, 22LLA696, 23ALA194, 23BLA985, 23CLA356, 23ELA844, 23FLA654, 23GLB027, 23HLA029, 23ILA700, 23JLB281; f) REF DYKE1840, UDI/DI 40195327105649 (case), 10195327105648 (unit), Lot Numbers: 22BBT072, 22EBU502, 22KBM213, 22LBH747; g) REF DYNJ37775F, UDI/DI 40888277906182 (case), 10888277906181 (unit), Lot Numbers: 22FDB681, 23ADC041, 23HDA605; h) REF DYNDL1350A, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers: 22GBH314, 23ABI645, 23BBL282, 23BBU137, 23EBM149, 23FBC531, 23GBJ019, 23HBD916; i) REF DYNDL1350AH, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers: 22GBH314, 23ABI645, 23BBL282, 23BBU137, 23EBM149, 23FBC531, 23GBJ019, 23HBD916; j) REF DYNDA2277A, UDI/DI 40195327004423 (case), 10195327003944 (unit), Lot Numbers: 21LBS528, 22ABD844, 22BBE910; k) REF DYNDA2277B, UDI/DI UDI/DI 40195327120796 (case), 10195327120795 (unit), Lot Numbers: 22CBP893, 22DBQ630, 22IBG117; l) REF DYNDC3006, UDI/DI 40193489421256 (case), 10193489421255 (unit), Lot Numbers: 22EBO159; m) REF DYNDJ1076, UDI/DI 40889942790617 (Case), 10889942790616 (unit), Lot Numbers: 22IBS404, 23BBU808, 23FBQ938; n) REF DT21230A, UDI/DI 40653160991503 (case), 10653160991502 (unit), Lot Numbers: 21LBS504, 22ABZ147, 22CBX302, 22DBD319, 22HBU059, 22IBG323; o) REF DT20350B, UDI/DI 40653160991558 (case), 10653160991557 (unit), Lot Numbers; : 21LBT644, 22ABJ769, 22ABN465, 22ABU739, 22DBE295,…
FDA’s list runs to 10,284 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.
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
The states and territories these words name
- Puerto Rico
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 Nov 15, 2023.
- FDA classified it on Feb 24, 2024.
- FDA’s Enforcement Report published it on Mar 6, 2024.
FDA, Device recall enforcement reports. Released Oct 23, 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 23, 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 10,284 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 23, 2026 and checked Oct 23, 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 24, 2026.