CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report
Medline procedure kits labeled as: Clovis Robotic-lf, Pack Number recalled
Medline Industries LP - Northfield is recalling Medline procedure kits labeled as: Clovis Robotic-lf, Pack Number, distributed nationwide in the US. The recall was initiated on 11 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1447-2025
- FDA event ID
- 96374
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Feb 2025
- FDA classified
- 25 Mar 2025
- Reported
- 2 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 11 Feb 2025 | Recall initiated by company | |
| 25 Mar 2025 | Classified by FDA | +42 days |
| 2 Apr 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
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.
Which lots are affected?
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), Lot Number 24AMD941Z; 16) Pack Number DYNJ0843760F: UDI/DI 10193489607833 (each) 40193489607834 (case), Lot Number 20BDB045A; 17) Pack Number DYNJ909233: UDI/DI 10195327310189 (each) 40195327310180 (case), Lot Number 23GBA187Z; 18) Pack Number DYNJ50238C: UDI/DI 10195327017484 (each) 40195327017485 (case), Lot Number 23HMC447A; 19) Pack Number DYNJ52564D: UDI/DI 10195327176426 (each) 40195327176427 (case), Lot Number 23GME685A; 20) Pack Number DYNJ43782K: UDI/DI 10193489989892 (each) 40193489989893 (case), Lot Number 22HBO266M; 21) Pack Number DYNJ49191B: UDI/DI 10193489497489 (each) 40193489497480 (case), Lot Number 21JMH124A; 22) Pack Number DYNJ37717K: UDI/DI 10195327409753 (each) 40195327409754 (case), Lot Number 23GME305A
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
18 other products · FDA event 96374This product is part of a recall event; the main page for the event is Medline procedure kits labeled as: C Scope Disposable Kit recalled.
More recalls from Medline Industries LP - Northfield
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|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
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