FDA Medical devices recall ·
Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF… recall
- Recall number
- Z-1447-2025
- Date
- (initiated February 11, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1711 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 (case), Lot Number 23KMC229A; 11) Pack Number SYNJ10073D: UDI/DI 10193489864540 (each) 40193489864541 (case), Lot Number 24ABA922Z; 12) Pack Number DYNJ0124452S: UDI/DI 10193489754216 (each) 40193489754217 (case), Lot Number 20HKB312A; 13) Pack Number PHS988229I: UDI/DI 10193489766035 (each) 40193489766036 (case), Lot Number 23GMB353A; 14) Pack Number DYNJ47274J: UDI/DI 10193489353631 (each) 40193489353632 (case), Lot Number 21IMG979A; 15) Pack Number DYNJ902845K: UDI/DI 10195327210199 (each) 40195327210190 (case)
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1447-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.