Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF — Class II medical device recall Z-1447-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-02, distributed nationwide. Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. L
| Recall number | Z-1447-2025 |
|---|---|
| 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 | 2025-02-11 |
| Classified | 2025-03-25 |
| Reported by FDA | 2025-04-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,711 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 10193489245684, 10193489323177, 10193489353631, 10193489395211, 10193489497489, 10193489607833, 10193489754216, 10193489766035, 10193489864540, 10193489989892, 10195327017484, 10195327096618, 10195327176426, 10195327210199, 10195327211097, 10195327310189, 10195327340360, 10195327409753, 10195327451509, 10195327478742, 10195327511203, 10889942975884, 40193489245685, 40193489323178, 40193489353632 and 19 more |
| Lot numbers | 20BDB045A, 20BDB396A, 20HKB312A, 21IMG979A, 21JMH124A, 21LBG879A, 22ABT041A, 22HBO266M, 23ABM287A, 23FBP444A, 23GBA187Z, 23GMB353A, 23GMD257A, 23GME305A, 23GME685A, 23HMC447A, 23IMF676A, 23JBI037Z, 23KMC229A, 23LMH303A, 24ABA922Z, 24AMD941Z |
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 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.
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-1447-2025. 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.