FDA Device recall Z-1447-2025
Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D
- 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) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D 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-1447-2025 |
| 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) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, Pack Number DYNJ0665103I; 3) DAVINCI PACK-RFD, Pack Number DYNJ47762O; 4) DAVINCI ROBOT PACK SLRMC, Pack Number DYNJ81236; 5) GENERAL ROBOTICS PACK, Pack Number DYNJ80546B; 6) GYN 1 PACK, Pack Number DYNJ43441C; 7) GYN LAP, Pack Number DYNJ909936; 8) GYN LAPAROSCOPY PACK, Pack Number DYNJ63014A; 9) GYN LAPAROSCOPY PACK, Pack Number DYNJ51739B; 10) GYN LAPAROSCOPY PACK, Pack Number DYNJ84181; 11) GYN LAPAROSCOPY PACK, Pack Number SYNJ10073D; 12) GYN LAPAROSCOPY PACK-LF, Pack Number DYNJ0124452S; 13) LAP GYN PACK-LF, Pack Number PHS988229I; 14) LAPAROSCOPIC GYN PACK, Pack Number DYNJ47274J; 15) MOR GYN, Pack Number DYNJ902845K; 16) PELVISCOPY PACK-LF, Pack Number DYNJ0843760F; 17) ROBOTIC GYN, Pack Number DYNJ909233; 18) ROBOTIC RENAL PACK, Pack Number DYNJ50238C; 19) SCRIPPS SW ROBOTIC PACK, Pack Number DYNJ52564D; 20) SVMMC GYN ROBOTIC PACK, Pack Number DYNJ43782K; 21) TASC GYN LAP, Pack Number DYNJ49191B; 22) URO-GYN ROBOTIC PACK, Pack Number DYNJ37717K
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 DYNJ61061D: UDI/DI 10195327451509 (each) 40195327451500 (case), Lot Number 23GMD257A; 2) Pack Number D…1) Pack Number DYNJ61061D: UDI/DI 10195327451509 (each) 40195327451500 (case), Lot Number 23GMD257A; 2) Pack Number DYNJ0665103I: UDI/DI 10193489395211 (each) 40193489395212 (case), Lot Number 23ABM287A; 3) Pack Number DYNJ47762O: UDI/DI 10195327478742 (each) 40195327478743 (case), Lot Number 23IMF676A; 4) Pack Number DYNJ81236: UDI/DI 10195327096618 (each) 40195327096619 (case), Lot Number 23LMH303A; 5) Pack Number DYNJ80546B: UDI/DI 10195327211097 (each) 40195327211098 (case), Lot Number 23FBP444A; 6) Pack Number DYNJ43441C: UDI/DI 10193489323177 (each) 40193489323178 (case), Lot Number 21LBG879A; 7) Pack Number DYNJ909936: UDI/DI 10195327511203 (each) 40195327511204 (case), Lot Number 23JBI037Z; 8) Pack Number DYNJ63014A: UDI/DI 10193489245684 (each) 40193489245685 (case), Lot Number 20BDB396A; 9) Pack Number DYNJ51739B: UDI/DI 10889942975884 (each) 40889942975885 (case), Lot Number 22ABT041A; 10) Pack Number DYNJ84181: UDI/DI 10195327340360 (each) 40195327340361 |
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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-1447-2025%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.