Device recall

Medline surgical convenience kits labeled as: 1) EAR, Medline product number/SKU DYNJ909020B; 2) EAR, Medline product number/SKU DYNJ909020A; 3) CAROTID PACK, Medline product number/SKU DYNJ42922C; 4) EAR, Medline product number/SKU DYNJ909020; 5) FEM CAROTID PACK, Medline product number/SKU DYNJ65706; 6) CAROTID CDS-LF, Medline product number/SKU CDS983139B.

FDA recall source

Recall number

Z-0173-2027

Event id

99886

Status

Ongoing

FDA classification

Class II

Recalling firm

Medline Industries, LP

Report date

Oct 21, 2026

Posted

Oct 15, 2026

Initiated

Sep 2, 2026

Center classification date

Oct 15, 2026

Product code

OGR

Device type

Ear, Nose, And Throat Surgical Tray

Reason

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Root cause

Under Investigation by firm

Quantity

620 kits

Code info

Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 26AMF311; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25JMD500; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25DMJ849; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25CMD823; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25BMG250; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 24LMG633; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24KMB736; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24JMD634; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24IMD605; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24HBT243; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24HBD143; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24GMG103; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24DMI379; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24CBJ928; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 24BME929; Medline product number/SKU DYNJ65706, UDI/DI 10193489284904 (each) 40193489284905 (case), Lot number 24AMF210; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 24AMD338; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23LME666; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23LMB230; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23KMF895; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23KMD188; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23HMH838; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23HBG421; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23FBD203; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23EBL260; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23CMB011; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23CBU833; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22BBV592; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22BBJ850; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22ABL217; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21LBM269; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21HBC597; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21GBE864; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21FBJ082.

Distribution

US Nationwide distribution.

Voluntary or mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States