Hearth Record

Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit

Medical device recall Z-1193-2026. Published in FDA’s Enforcement Report on Feb 4, 2026.

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 Feb 4, 2026. 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?

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

Source:

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

Which ones are recalled?

Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU ACC010690; 3) DRAWER 3 SYR/DRS/MON/NG 1 OF 3, Kit SKU ACC011073; 4) HYPOSPADIUS PACK, Kit SKU DYNJ00282Q; 5) SJ NEURO PACK RFID-LF, Kit SKU DYNJ0101360K; 6) CENTRAL LINE PACK-LF, Kit SKU DYNJ0220136S; 7) SPINE PACK-LF, Kit SKU DYNJ0376635Q; 8) ORTHO SPINAL PACK-LF, Kit SKU DYNJ0460768T; 9) W.C. MINOR LAPAROTOMY PK-LF, Kit SKU DYNJ0509186J; 10) NEURO SHUNT PACK-LF, Kit SKU DYNJ0578815W; 11) ANCILLARY SPINE PACK-LF, Kit SKU DYNJ0610290T; 12) MINOR LAPAROTOMY PACK-LF, Kit SKU DYNJ0753436P; 13) KNEE SCOPE PACK-LF, Kit SKU DYNJ0890502R; 14) PEDIATRIC PACK-LF, Kit SKU DYNJ28212L; 15) ANTERIOR CERVICAL PACK, Kit SKU DYNJ31341P; 16) PEDIATRIC MINOR PROCEDURE PACK, Kit SKU DYNJ37615J; 17) LAPAROSCOPY PACK, Kit SKU DYNJ39215N; 18) MAJOR LAP VCH, Kit SKU DYNJ39217P; 19) NEURO PACK, Kit SKU DYNJ39220N; 20) CAS HAND PK, Kit SKU DYNJ39468G; 21) RFT ISC NOBLES MINOR PACK, Kit SKU DYNJ43954B; 22) PED OPEN HEART PACK, Kit SKU DYNJ45373G; 23) MAJOR GENERAL PACK-LF, Kit SKU DYNJ51436F; 24) MINOR PK-LF, Kit SKU DYNJ51437C; 25) VEIN ABLATION & EXCISION ASC, Kit SKU DYNJ52586C; 26) SHOULDER PACK, Kit SKU DYNJ56889B; 27) LAP CHOLE PACK, Kit SKU DYNJ57206F; 28) TRANSGENDER MASTECTOMY 2, Kit SKU DYNJ58257I; 29) SHOULDER ARTH PACK, Kit SKU DYNJ58410D; 30) MAJOR PACK, Kit SKU DYNJ58528J; 31) PACK BREAST, Kit SKU DYNJ60157F; 32) CH TRANSPHENOIDAL PACK, Kit SKU DYNJ61696I; 33) RR-SPINE PACK, Kit SKU DYNJ62643B; 34) MINOR PACK, Kit SKU DYNJ64238D; 35) PBMS NECK PACK-LF, Kit SKU DYNJ64961C; 36) BREAST PACK, Kit SKU DYNJ64988C; 37) MINOR PACK 180110, Kit SKU DYNJ65447C; 38) PACK,V-P SHUNT, Kit SKU DYNJ65472C; 39) BASIC PACK, Kit SKU DYNJ65996D; 40) MINOR SS, Kit SKU DYNJ66094A; 41) CRMC ROBOTIC GENERAL PACK, Kit SKU DYNJ66613D; 42) PEDIATRIC GENERAL PACK, Kit SKU DYNJ66644F; 43) URO/GYN PACK, Kit SKU DYNJ66675F; 44) SHOULDER SCOPE PACK, Kit SKU DYNJ68707B; 45) SPECIALTY FACIAL PLASTICS PACK, Kit SKU DYNJ68844B; 46) SPECIALTY FACIAL PLASTICS PACK, Kit SKU DYNJ68844C; 47) ACF PACK, Kit SKU DYNJ69112C; 48) SM OR-DR. YEH PACK-LF, Kit SKU DYNJ69705C; 49) SHOULDER ARTHROSCOPY PACK, Kit SKU DYNJ81752C; 50) C BIRTH SET UP PACK, Kit SKU DYNJ81994C; 51) TRIAL PACK, Kit SKU DYNJ82770A; 52) PROSTATE ROBOTIC PACK, Kit SKU DYNJ84120C; 53) HAND PACK, Kit SKU DYNJ85033A; 54) ARTHROSCOPY PACK, Kit SKU DYNJ85197A; 55) GU-GYN-LITHO PACK, Kit SKU DYNJ86013A; 56) DBD-ARTHROSCOPY PACK, Kit SKU DYNJ86963A; 57) BREAST PACK, Kit SKU DYNJ87587A; 58) PACK,PEDIATRIC MINOR, Kit SKU DYNJ88718; 59) UNIVERSAL-ASC, Kit SKU DYNJ900071C; 60) BASIC, Kit SKU DYNJ905869G; 61) PACK,PEDIATRIC MAJOR, Kit SKU DYNJ906888F; 62) HAND/FOOT PACK, Kit SKU DYNJT3131A; 63) SHOULDER PACK, Kit SKU DYNJT3266; 64) LUMBAR PACK, Kit SKU DYNJT4178; 65) CVS ICU PACK, Kit SKU PHS41728D; 66) SINGLE TAP BLOCK TRAY, Kit SKU SPEC0156A.

857 units, in FDA’s words.

Source:

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

Codes to check against yours

Medline Kit SKU ACC010270A: UDI/DI 10889942219827 (EA) 40889942219828 (CS), Lot Number 25LDA153; Medline Kit SKU ACC010690: UDI/DI 10195327433307 (EA) 40195327433308 (CS), Lot Number 25LDA088; Medline Kit SKU ACC011073: UDI/DI…

Every code shown here, 1,995 characters

Medline Kit SKU ACC010270A: UDI/DI 10889942219827 (EA) 40889942219828 (CS), Lot Number 25LDA153; Medline Kit SKU ACC010690: UDI/DI 10195327433307 (EA) 40195327433308 (CS), Lot Number 25LDA088; Medline Kit SKU ACC011073: UDI/DI 10198459569333 (EA) 40198459569334 (CS), Lot Number 25LDA072; Medline Kit SKU DYNJ00282Q: UDI/DI 10195327412029 (EA) 40195327412020 (CS), Lot Number 25KMC904; Medline Kit SKU DYNJ00282Q: UDI/DI 10195327412029 (EA) 40195327412020 (CS), Lot Number 25LMA071; Medline Kit SKU DYNJ0101360K: UDI/DI 10195327662066 (EA) 40195327662067 (CS), Lot Number 25KMC709; Medline Kit SKU DYNJ0220136S: UDI/DI 10198459566073 (EA) 40198459566074 (CS), Lot Number 25KMB403; Medline Kit SKU DYNJ0220136S: UDI/DI 10198459566073 (EA) 40198459566074 (CS), Lot Number 25JMF503; Medline Kit SKU DYNJ0376635Q: UDI/DI 10198459422591 (EA) 40198459422592 (CS), Lot Number 25KMH121; Medline Kit SKU DYNJ0376635Q: UDI/DI 10198459422591 (EA) 40198459422592 (CS), Lot Number 25KMF780; Medline Kit SKU DYNJ0460768T: UDI/DI 10198459466809 (EA) 40198459466800 (CS), Lot Number 25KMH789; Medline Kit SKU DYNJ0509186J: UDI/DI 10198459117626 (EA) 40198459117627 (CS), Lot Number 25KME895; Medline Kit SKU DYNJ0578815W: UDI/DI 10198459466892 (EA) 40198459466893 (CS), Lot Number 25JMJ695; Medline Kit SKU DYNJ0610290T: UDI/DI 10198459021558 (EA) 40198459021559 (CS), Lot Number 25KMC723; Medline Kit SKU DYNJ0753436P: UDI/DI 10198459466854 (EA) 40198459466855 (CS), Lot Number 25KMJ740; Medline Kit SKU DYNJ0890502R: UDI/DI 10198459431098 (EA) 40198459431099 (CS), Lot Number 25KME522; Medline Kit SKU DYNJ28212L: UDI/DI 10193489322118 (EA) 40193489322119 (CS), Lot Number 25KBE916; Medline Kit SKU DYNJ31341P: UDI/DI 10198459069352 (EA) 40198459069353 (CS), Lot Number 25KMA795; Medline Kit SKU DYNJ37615J: UDI/DI 10195327560881 (EA) 40195327560882 (CS), Lot Number 25KDB706; Medline Kit SKU DYNJ39215N: UDI/DI 10198459102240 (EA) 40198459102241 (CS), Lot Number 25KMH027; Medline Kit SKU DYNJ39217P: UDI/DI…

FDA’s list runs to 6,710 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.

US Nationwide distribution.

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.

Source:

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.

Source:

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

  • The firm began the recall on Dec 12, 2025.
  • FDA classified it on Jan 28, 2026.
  • FDA’s Enforcement Report published it on Feb 4, 2026.
Source:

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.
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 6,710 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.

An example record, made up for this guide

An example nursing home

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.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

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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