CLASS II ONGOING Device recall · Reported 4 Feb 2026 · FDA Enforcement Report
Medline medical procedure convenience kits labeled as recalled
Medline Industries is recalling Medline medical procedure convenience kits labeled as: Drawer 1 Airway, Kit, distributed nationwide in the US. The recall was initiated on 12 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1193-2026
- FDA event ID
- 98226
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Dec 2025
- FDA classified
- 28 Jan 2026
- Reported
- 4 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 12 Dec 2025 | Recall initiated by company | |
| 28 Jan 2026 | Classified by FDA | +47 days |
| 4 Feb 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution.
Stores named: CVS
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 98226This product is part of a recall event; the main page for the event is Medline medical procedure convenience kits labeled as recalled.
More recalls from Medline Industries
All 709| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Burgundy recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Blue recalled by Medline Industries | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |