Medline brand medical procedure convenience kits — Class II medical device recall Z-0160-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-10-30, distributed nationwide. It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may re
| Recall number | Z-0160-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-09-04 |
| Classified | 2024-10-23 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 2,740 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10193489304602, 10193489507997, 10193489637182, 10193489700244, 10193489741643, 10193489779370, 10193489812565, 10193489962840, 10193489981520, 10195327059538, 10195327151980, 10195327153670, 10195327207083, 10195327214333, 10195327220143, 10195327226510, 10195327236885, 10195327276874, 10195327332235, 10195327341633, 10195327394530, 10195327456450, 10195327483029, 10195327493752, 10195327512521 and 39 more |
| Lot numbers | 23KBA462, 23KBB859, 23KBC298, 23KBC605, 23KBD353, 23KBD956, 23KBD998, 23KBE536, 23LBF682, 23LBL823, 23LBN122, 23LBP334, 23LBP611, 23LBQ627, 23LBQ806, 23LBU511, 24ABA207, 24ABA446, 24ABB114, 24ABB272, 24ABC423, 24ABC426, 24ABD026, 24ABD228, 24ABD861, 24ABE249, 24ABE284, 24ABS131, 24ABS137, 24ABS337, 24ABU280, 24BBA623, 24CBA800, 24CBI692 |
| Model numbers | CDS982091I, CDS984492B, DYNJ0798129I, DYNJ30591I, DYNJ37171A, DYNJ40836F, DYNJ44249J, DYNJ44349L, DYNJ44349M, DYNJ53200C, DYNJ53270C, DYNJ54610A, DYNJ55255C, DYNJ58979, DYNJ62927, DYNJ63190A, DYNJ66274A, DYNJ67109B, DYNJ68417C, DYNJ80227B, DYNJ80559A, DYNJ81880, DYNJ83158, DYNJ84083, DYNJ900289J and 7 more |
Product
Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF DYNJ40836F; 7) ENT PACK, REF DYNJ44249J; 8) TONSIL PACK, REF DYNJ44349L; 9) TONSIL PACK, REF DYNJ44349M; 10) NASAL PACK, REF DYNJ53200C; 11) TONSIL & ADENOIDS PACK, REF DYNJ53270C; 12) FTMC MYRINGOTOMY PACK-LF, REF DYNJ54610A; 13) HEAD AND NECK PACK, REF DYNJ55255C; 14) ENT T&A PACK, REF DYNJ58979; 15) EENT PACK, REF DYNJ62927; 16) ENT, REF DYNJ63190A; 17) D L B PACK, REF DYNJ66274A; 18) ASC T&A, REF DYNJ67109B; 19) TONSIL T AND A PACK SHD, REF DYNJ68417C; 20) T A PACK, REF DYNJ80227B; 21) TONSIL AND ADENOID PACK, REF DYNJ80559A; 22) T AND A PACK UMMC KIT, REF DYNJ81880; 23) T/A ENDO PACK, REF DYNJ83158; 24) JVL - MODULE T A PK, REF DYNJ84083; 25) T&A, REF DYNJ900289J; 26) T&A, REF DYNJ900289J; 27) T & A, REF DYNJ902626G; 28) LARYNGOSCOPY BRONCH-LF, REF DYNJ903264A; 29) T&A, REF DYNJ903428J; 30) T&A, REF DYNJ903428J; 31) PEDI ENT - OAKBEND, REF DYNJ905769; 32) T & A, REF DYNJ907056C; 33) ASC FARRELL T&A, REF DYNJ908132; 34) CHS ENT PACK, REF DYNJCH500
Reason for recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0160-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.