FDA Device recall Z-1448-2025
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622
- FDA Device
- Class II
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class II recall of Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622 by Medline Industries Northfield, citing 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 ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1448-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-11 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF, Pack Number DYNJ55345D; 7) C-SECTION PACK, Pack Number DYNJ04521J; 8) C-SECTION PACK, Pack Number DYNJ32632F; 9) C-SECTION PACK, Pack Number DYNJ65961B; 10) SMJ C-SECTION PACK-LF, Pack Number DYNJ38582J
Reason
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.
Identifiers
| code_info | 1) Pack Number DYNJ57622: UDI/DI 10889942757244 (each) 40889942757245 (case), Lot Number 20LMF902A; 2) Pack Number DY…1) Pack Number DYNJ57622: UDI/DI 10889942757244 (each) 40889942757245 (case), Lot Number 20LMF902A; 2) Pack Number DYNJ48483B: UDI/DI 10193489659405 (each) 40193489659406 (case), Lot Number 20CKB746A; 3) Pack Number DYNJ61573: UDI/DI 10193489601077 (each) 40193489601078 (case), Lot Number 22CMB584A; 4) Pack Number DYNJ66801: UDI/DI 10193489384000 (each) 40193489384001 (case), Lot Number 22GBW063A; 5) Pack Number DYNJ0367951P: UDI/DI 10193489966923 (each) 40193489966924 (case), Lot Number 21IMH644A; 6) Pack Number DYNJ55345D: UDI/DI 10195327173722 (each) 40195327173723 (case), Lot Number 22GBJ830A; 7) Pack Number DYNJ04521J: UDI/DI 10193489555837 (each) 40193489555838 (case), Lot Number 21HMA851A; 8) Pack Number DYNJ32632F: UDI/DI 10193489888966 (each) 40193489888967 (case), Lot Number 21IMD959A; 9) Pack Number DYNJ65961B: UDI/DI 10193489984309 (each) 40193489984300 (case), Lot Number 23LMG679A; 10) Pack Number DYNJ38582J: UDI/DI 10193489528244 (each) 40193489528245 ( |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1448-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.