Class II Recall

Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU

Summary

The FDA issued a Class II for Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Ki by Medline Industries, LP. Reason: Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing crack.

Details

Source

Device Recall

External ID

Z-1193-2026

Action Date

2026-02-04

Status

Ongoing

Product Description

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.

Lot/Code Info: 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 10198459102356 (EA) 40198459102357 (CS), Lot Number 25LMA409; Medline Kit SKU DYNJ39220N: UDI/DI 10198459102387 (EA) 40198459102388 (CS), Lot Number 25KMJ608; Medline Kit SKU DYNJ39468G: UDI/DI 10198459408595 (EA) 40198459408596 (CS), Lot Number 25KMD121; Medline Kit SKU DYNJ43954B: UDI/DI 10193489509168 (EA) 40193489509169 (CS), Lot Number 25KMD726; Medline Kit SKU DYNJ45373G: UDI/DI 10198459254635 (EA) 40198459254636 (CS), Lot Number 25JMH775; Medline Kit SKU DYNJ51436F: UDI/DI 10198459004315 (EA) 40198459004316 (CS), Lot Number 25KMG978; Medline Kit SKU DYNJ51437C: UDI/DI 10198459005114 (EA) 40198459005115 (CS), Lot Number 25JMJ673; Medline Kit SKU DYNJ52586C: UDI/DI 10195327596521 (EA) 40195327596522 (CS), Lot Number 25KMH637; Medline Kit SKU DYNJ56889B: UDI/DI 10198459490088 (EA) 40198459490089 (CS), Lot Number 25KBE707; Medline Kit SKU DYNJ57206F: UDI/DI 10195327682958 (EA) 40195327682959 (CS), Lot Number 25KMG080; Medline Kit SKU DYNJ58257I: UDI/DI 10198459565526 (EA) 40198459565527 (CS), Lot Number 25LMA492; Medline Kit SKU DYNJ58410D: UDI/DI 10198459366468 (EA) 40198459366469 (CS), Lot Number 25KBF113; Medline Kit SKU DYNJ58528J: UDI/DI 10198459322815 (EA) 40198459322816 (CS), Lot Number 25JBW494; Medline Kit SKU DYNJ60157F: UDI/DI 10198459343445 (EA) 40198459343446 (CS), Lot Number 25KMI064; Medline Kit SKU DYNJ61696I: UDI/DI 10198459208713 (EA) 40198459208714 (CS), Lot Number 25KMF819; Medline Kit SKU DYNJ62643B: UDI/DI 10198459164446 (EA) 40198459164447 (CS), Lot Number 25KMB841; Medline Kit SKU DYNJ64238D: UDI/DI 10198459068447 (EA) 40198459068448 (CS), Lot Number 25KME422; Medline Kit SKU DYNJ64961C: UDI/DI 10198459569777 (EA) 40198459569778 (CS), Lot Number 25KMD570; Medline Kit SKU DYNJ64988C: UDI/DI 10198459373008 (EA) 40198459373009 (CS), Lot Number 25LMB275; Medline Kit SKU DYNJ65447C: UDI/DI 10198459605222 (EA) 40198459605223 (CS), Lot Number 25LMA822; Medline Kit SKU DYNJ65472C: UDI/DI 10198459168727 (EA) 40198459168728 (CS), Lot Number 25KMD067; Medline Kit SKU DYNJ65996D: UDI/DI 10198459376726 (EA) 40198459376727 (CS), Lot Number 25KMJ550; Medline Kit SKU DYNJ66094A: UDI/DI 10198459462689 (EA) 40198459462680 (CS), Lot Number 25LMB276; Medline Kit SKU DYNJ66613D: UDI/DI 10198459504488 (EA) 40198459504489 (CS), Lot Number 25KMI271; Medline Kit SKU DYNJ66644F: UDI/DI 10198459574160 (EA) 40198459574161 (CS), Lot Number 25KMD640; Medline Kit SKU DYNJ66675F: UDI/DI 10198459574108 (EA) 40198459574109 (CS), Lot Number 25LMA853; Medline Kit SKU DYNJ68707B: UDI/DI 10198459001734 (EA) 40198459001735 (CS), Lot Number 25KBE843; Medline Kit SKU DYNJ68844B: UDI/DI 10198459232428 (EA) 40198459232429 (CS), Lot Number 25KMF829; Medline Kit SKU DYNJ68844C: UDI/DI 10198459608360 (EA) 40198459608361 (CS), Lot Number 25LMA922; Medline Kit SKU DYNJ69112C: UDI/DI 10198459176128 (EA) 40198459176129 (CS), Lot Number 25KME071; Medline Kit SKU DYNJ69705C: UDI/DI 10198459164460 (EA) 40198459164461 (CS), Lot Number 25LMB062; Medline Kit SKU DYNJ81752C: UDI/DI 10198459272721 (EA) 40198459272722 (CS), Lot Number 25KDB800; Medline Kit SKU DYNJ81994C: UDI/DI 10198459105203 (EA) 40198459105204 (CS), Lot Number 25KMH388; Medline Kit SKU DYNJ82770A: UDI/DI 10198459411755 (EA) 40198459411756 (CS), Lot Number 25JME725; Medline Kit SKU DYNJ84120C: UDI/DI 10198459574177 (EA) 40198459574178 (CS), Lot Number 25KMB382; Medline Kit SKU DYNJ85033A: UDI/DI 10195327605629 (EA) 40195327605620 (CS), Lot Number 25KMI735; Medline Kit SKU DYNJ85197A: UDI/DI 10198459217395 (EA) 40198459217396 (CS), Lot Number 25JMD376; Medline Kit SKU DYNJ86013A: UDI/DI 10198459133527 (EA) 40198459133528 (CS), Lot Number 25LDA111; Medline Kit SKU DYNJ86963A: UDI/DI 10198459573330 (EA) 40198459573331 (CS), Lot Number 25KMD001; Medline Kit SKU DYNJ87587A: UDI/DI 10198459114199 (EA) 40198459114190 (CS), Lot Number 25KBE931; Medline Kit SKU DYNJ88718: UDI/DI 10198459195099 (EA) 40198459195090 (CS), Lot Number 25KMF429; Medline Kit SKU DYNJ900071C: UDI/DI 10198459121722 (EA) 40198459121723 (CS), Lot Number 25KMH899; Medline Kit SKU DYNJ905869G: UDI/DI 10198459394577 (EA) 40198459394578 (CS), Lot Number 25JBX559; Medline Kit SKU DYNJ906888F: UDI/DI 10198459194764 (EA) 40198459194765 (CS), Lot Number 25LMA693; Medline Kit SKU DYNJT3131A: UDI/DI 10198459519123 (EA) 40198459519124 (CS), Lot Number 25LMA999; Medline Kit SKU DYNJT3266: UDI/DI 10198459320965 (EA) 40198459320966 (CS), Lot Number 25KMI561; Medline Kit SKU DYNJT4178: UDI/DI 10198459421020 (EA) 40198459421021 (CS), Lot Number 25KMB763; Medline Kit SKU PHS41728D: UDI/DI 10198459438691 (EA) 40198459438692 (CS), Lot Number 25JBW576; Medline Kit SKU SPEC0156A: UDI/DI 10888277239012 (EA) 40888277239013 (CS), Lot Number 25JBW895.

Quantity Affected: 857 units

Reason for Recall

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.

Distribution

US Nationwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-12-12

Company

Medline Industries, LP

Northfield, IL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 175 device recalls issued in the same week, part of 413 device-related FDA actions this month.

Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Medline Industries, LP have FDA actions?

Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1193-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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