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.

Class II

Recalling firm: Medline Industries, LP
Reason for recall: 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.
Affected products (lot / model / serial): 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.
Units affected: 620 kits
Distribution pattern: US Nationwide distribution.
Firm location: Northfield, IL, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type: Devices
Status: Ongoing
Recall number: Z-0173-2027
Recall initiated: September 2, 2026
FDA classification date: October 15, 2026
FDA report date: October 21, 2026
FDA event ID: 99886
Last updated on HTM Vibe: October 27, 2026

View on openFDA