PlainRecalls
FDA Devices Moderate Class II Ongoing

Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Number DYNJ54064; 5) EAR PACK, Pack Number DYNJ68678C; 6) ENT HEAD NECK PACK, Pack Number DYNJ49023D; 7) ENT PACK, Pack Number DYNJ42564B; 8) ENT PACK, Pack Number DYNJ50572; 9) ENT PACK, Pack Number DYNJ45175B; 10) ENT PACK, Pack Number DYNJ65585A; 11) EP PACK, Pack Nu

Reported: April 2, 2025 Initiated: February 11, 2025 #Z-1461-2025

Product Description

Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Number DYNJ54064; 5) EAR PACK, Pack Number DYNJ68678C; 6) ENT HEAD NECK PACK, Pack Number DYNJ49023D; 7) ENT PACK, Pack Number DYNJ42564B; 8) ENT PACK, Pack Number DYNJ50572; 9) ENT PACK, Pack Number DYNJ45175B; 10) ENT PACK, Pack Number DYNJ65585A; 11) EP PACK, Pack Number DYNJ59171; 12) FUNCTIONAL ENDO SINUS WEILER, Pack Number DYNJ58857A; 13) HEAD & NECK, Pack Number DYNJ902987F; 14) HEAD & NECK PACK, Pack Number DYNJ61295B; 15) HEAD & NECK PACK, Pack Number DYNJ30234B; 16) HEAD & NECK PACK, Pack Number DYNJ50383; 17) HEAD & NECK PACK, Pack Number DYNJ36634K; 18) HEAD & NECK PACK, Pack Number DYNJ66399; 19) HEAD AND NECK PACK-LF, Pack Number DYNJ38402I; 20) MAJOR ENT HARPER PACK-LF, Pack Number DYNJ0161710I; 21) NASAL SINUS PACK-LF, Pack Number DYNJ0751486N; 22) NE NASAL, Pack Number DYNJ03130D; 23) ORL PACK, Pack Number DYNJ63705B; 24) SINUS PACK, Pack Number DYNJ50110B; 25) SINUS PACK, Pack Number DYNJ50110B; 26) T & A PACK, Pack Number DYNJ58811A; 27) THORACIC PACK, Pack Number DYNJ30731M; 28) THYROIDECTOMIE DIAGNOSTIQUE-LF, Pack Number DYNJ42678A; 29) TONSILS & ADENOIDS, Pack Number DYNJ69465; 30) TRANSPHENOIDAL PACK, Pack Number DYNJ46556B;

Reason for Recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Details

Units Affected
2161 kits
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Number DYNJ54064; 5) EAR PACK, Pack Number DYNJ68678C; 6) ENT HEAD NECK PACK, Pack Number DYNJ49023D; 7) ENT PACK, Pack Number DYNJ42564B; 8) ENT PACK, Pack Number DYNJ50572; 9) ENT PACK, Pack Number DYNJ45175B; 10) ENT PACK, Pack Number DYNJ65585A; 11) EP PACK, Pack Number DYNJ59171; 12) FUNCTIONAL ENDO SINUS WEILER, Pack Number DYNJ58857A; 13) HEAD & NECK, Pack Number DYNJ902987F; 14) HEAD & NECK PACK, Pack Number DYNJ61295B; 15) HEAD & NECK PACK, Pack Number DYNJ30234B; 16) HEAD & NECK PACK, Pack Number DYNJ50383; 17) HEAD & NECK PACK, Pack Number DYNJ36634K; 18) HEAD & NECK PACK, Pack Number DYNJ66399; 19) HEAD AND NECK PACK-LF, Pack Number DYNJ38402I; 20) MAJOR ENT HARPER PACK-LF, Pack Number DYNJ0161710I; 21) NASAL SINUS PACK-LF, Pack Number DYNJ0751486N; 22) NE NASAL, Pack Number DYNJ03130D; 23) ORL PACK, Pack Number DYNJ63705B; 24) SINUS PACK, Pack Number DYNJ50110B; 25) SINUS PACK, Pack Number DYNJ50110B; 26) T & A PACK, Pack Number DYNJ58811A; 27) THORACIC PACK, Pack Number DYNJ30731M; 28) THYROIDECTOMIE DIAGNOSTIQUE-LF, Pack Number DYNJ42678A; 29) TONSILS & ADENOIDS, Pack Number DYNJ69465; 30) TRANSPHENOIDAL PACK, Pack Number DYNJ46556B;. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 2161 kits.
Why was this product recalled?
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 2, 2025. Severity: Moderate. Recall number: Z-1461-2025.