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Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN...

FDA Device Recall #Z-1447-2025 — Class II — February 11, 2025

Recall Summary

Recall Number Z-1447-2025
Classification Class II — Moderate risk
Date Initiated February 11, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices
Quantity 1711 units

Product Description

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.

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Lot / Code Information

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

Other Recalls from MEDLINE INDUSTRIES, LP - Northfield

Recall # Classification Product Date
Z-2567-2025 Class I Medline medical convenience kits labeled as: ... Jul 25, 2025
Z-2566-2025 Class I Medline medical convenience kits labeled as: ... Jul 25, 2025
Z-2479-2025 Class II Medline Kits containing BD SureStep Foley Tray ... Jul 23, 2025
Z-2460-2025 Class I Medline ReNewal Reprocessed St. Jude Medical Re... Jul 14, 2025
Z-2452-2025 Class II The Medline General Surgery Tray is customized ... Jul 8, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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