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RecallWatchMedical Device Safety
Class IIOngoingZ-1447-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF

MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesReported Apr 2, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

Lot #
23GMD257A; 2) Pack Number DYNJ0665103I: UDI/DI 10193489395211 (each) 40193489395212 (case)
Lot #
23ABM287A; 3) Pack Number DYNJ47762O: UDI/DI 10195327478742 (each) 40195327478743 (case)
Lot #
23IMF676A; 4) Pack Number DYNJ81236: UDI/DI 10195327096618 (each) 40195327096619 (case)
Lot #
23LMH303A; 5) Pack Number DYNJ80546B: UDI/DI 10195327211097 (each) 40195327211098 (case)
Lot #
23FBP444A; 6) Pack Number DYNJ43441C: UDI/DI 10193489323177 (each) 40193489323178 (case)
Lot #
21LBG879A; 7) Pack Number DYNJ909936: UDI/DI 10195327511203 (each) 40195327511204 (case)
Lot #
23JBI037Z; 8) Pack Number DYNJ63014A: UDI/DI 10193489245684 (each) 40193489245685 (case)
Lot #
20BDB396A; 9) Pack Number DYNJ51739B: UDI/DI 10889942975884 (each) 40889942975885 (case)
Lot #
22ABT041A; 10) Pack Number DYNJ84181: UDI/DI 10195327340360 (each) 40195327340361 (case)
Lot #
23KMC229A; 11) Pack Number SYNJ10073D: UDI/DI 10193489864540 (each) 40193489864541 (case)
Show 12 more code fields
Lot #
24ABA922Z; 12) Pack Number DYNJ0124452S: UDI/DI 10193489754216 (each) 40193489754217 (case)
Lot #
20HKB312A; 13) Pack Number PHS988229I: UDI/DI 10193489766035 (each) 40193489766036 (case)
Lot #
23GMB353A; 14) Pack Number DYNJ47274J: UDI/DI 10193489353631 (each) 40193489353632 (case)
Lot #
21IMG979A; 15) Pack Number DYNJ902845K: UDI/DI 10195327210199 (each) 40195327210190 (case)
Lot #
24AMD941Z; 16) Pack Number DYNJ0843760F: UDI/DI 10193489607833 (each) 40193489607834 (case)
Lot #
20BDB045A; 17) Pack Number DYNJ909233: UDI/DI 10195327310189 (each) 40195327310180 (case)
Lot #
23GBA187Z; 18) Pack Number DYNJ50238C: UDI/DI 10195327017484 (each) 40195327017485 (case)
Lot #
23HMC447A; 19) Pack Number DYNJ52564D: UDI/DI 10195327176426 (each) 40195327176427 (case)
Lot #
23GME685A; 20) Pack Number DYNJ43782K: UDI/DI 10193489989892 (each) 40193489989893 (case)
Lot #
22HBO266M; 21) Pack Number DYNJ49191B: UDI/DI 10193489497489 (each) 40193489497480 (case)
Lot #
21JMH124A; 22) Pack Number DYNJ37717K: UDI/DI 10195327409753 (each) 40195327409754 (case)
Lot #
23GME305A

What the firm is doing

Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. This is an expansion of RES 94583

DistributionShow details

Worldwide distribution - US Nationwide and the country of Canada.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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