FDA Device recall Z-3049-2024

Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100

FDA Device
Class II
ongoing
Published 2024-09-18

On 2024-09-18 the FDA classified a Class II recall of Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100 by Medline Industries Northfield, citing 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 m….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-3049-2024
Classification	Class II
Status	ongoing
Initiated	2024-04-08
Published	2024-09-18
Last updated	2026-09-13 11:57 UTC
Company	Medline Industries Northfield
Distribution	n/a

Product

Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049AF; 4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ; 5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088Q ; 6) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088R ; 7) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088S ; 8) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186P ; 9) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186R ; 10) LAVH CDS, Pack Number CDS920130K ; 11) LAVH PROCEDURE, Pack Number CDS980754R ; 12) LAVH PROCEDURE, Pack Number CDS980754S ; 13) VAG HYST KIT, Pack Number CDS981313L ; 14) VAG HYST KIT, Pack Number CDS981313M ; 15) MINOR LITHOTOMY , Pack Number CDS982037W ; 16) MAJOR LITHOTOMY , Pack Number CDS982052V ; 17) D&C CDS , Pack Number CDS982061K ; 18) LAVH, Pack Number CDS982273Q ; 19) LAVH, Pack Number CDS982273R ; 20) LAVH, Pack Number CDS982273S ; 21) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397C ; 22) D&C HYSTEROSCOPY CDS-LF , Pack Number CDS982602K ; 23) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662P ; 24) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662Q ; 25) ABDOMINAL HYSTERECTOMY CDS SJF, Pack Number CDS982669N ; 26) GYN LITHOTOMY CDS SJF-LF, Pack Number CDS982679M ; 27) VAGINAL MAJOR , Pack Number CDS982689S ; 28) VAGINAL MAJOR , Pack Number CDS982689T ; 29) GYN/ABDOMINAL , Pack Number CDS982725K ; 30) GYN/ABDOMINAL , Pack Number CDS982725N ; 31) MAG MAJOR VAGINAL CDS , Pack Number CDS982907J ; 32) MAG MAJOR VAGINAL CDS , Pack Number CDS982907M ; 33) VAG HYST/SLING CDS-3, Pack Number CDS983006D ; 34) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055J ; 35) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055K ; 36) CUH LITHOTOMY CDS , Pack Number CDS983207M ; 37) CUH LITHOTOMY CDS , Pack Number CDS983207N ; 38) VAGINAL MINOR , Pack Number CDS983268I ; 39) LAVH CDS, Pack Number CDS983411I ; 40) LAVH CDS, Pack Number CDS983411J ; 41) LAVH CDS, Pack Number CDS983411K ; 42) LAVH PROCEDURE, Pack Number CDS983449L ; 43) LAVH PROCEDURE, Pack Number CDS983449M ; 44) LAVH PROCEDURE, Pack Number CDS983449N ; 45) LAVH CDS, Pack Number CDS983455C ; 46) MAJOR VAGINAL , Pack Number CDS983497J ; 47) MAJOR VAGINAL , Pack Number CDS983497L ; 48) LAPAROTOMY GYN CDS, Pack Number CDS983529M ; 49) VAG HYST CDS, Pack Number CDS983697J ; 50) GYN LITHOTOMY MAJOR LAC CDS , Pack Number CDS983780I ; 51) GYN MAJOR ABDOMINAL LAC CDS , Pack Number CDS983803K ; 52) GYN MINOR CDS , Pack Number CDS983985G ; 53) GYN ABDOMINAL CDS , Pack Number CDS983988A ; 54) MAJOR GYN LAPAROSCOPY CDS , Pack Number CDS984007C ; 55) TVT CDS , Pack Number CDS984091J ; 56) GROTH VAGINAL CDS , Pack Number CDS984201T ; 57) NHP Abdominal Hyst CDS, Pack Number CDS984234J ; 58) GYN CDS , Pack Number CDS984676C ; 59) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304; 60) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304A ; 61) DAVINCI HYSTERECTOMY CDS, Pack Number CDS985344F ; 62) HYSTEROSCOPY/D&C, Pack Number CDS985522G ; 63) MAJOR & MINOR LITHOTOMY , Pack Number CDS985525J ; 64) MAJOR LITHOTOMY , Pack Number CDS985547N ; 65) PROCEDURE TRAY, Pack Number DYNDA2966; 66) PERI-GYN PACK-LF, Pack Number DYNJ0038057A ; 67) TVH TRAY, Pack Number DYNJ00460L ; 68) TVH TRAY, Pack Number DYNJ00460M ; 69) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646F ; 70) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646G ; 71) LAVH PACK-LF, Pack Number DYNJ00470K ; 72) LAVH PACK-LF, Pack Number DYNJ00470L ; 73) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D ; 74) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768F ; 75) VAG. HYST TRAY-LF , Pack Number DYNJ0209066N ; 76) PERI GYN PACK-LF, Pack Number DYNJ0362432P ; 77) LAVH PACK-LF, Pack Number DYNJ0372824Q ; 78) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807I ; 79) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807J ; 80) VAGINAL HYSTERECTOMY PACK-

Reason

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.

Identifiers

code_info	C040100, Lot Number 19BDB794 ; C040100, Lot Number 19BDB938 ; C040100, Lot Number 19CDD009 ; C040100, Lot Number 19E… C040100, Lot Number 19BDB794 ; C040100, Lot Number 19BDB938 ; C040100, Lot Number 19CDD009 ; C040100, Lot Number 19EDC262 ; C040100, Lot Number 19EDC533 ; C040100, Lot Number 19JDA569 ; C040100, Lot Number 19JDA836 ; C040100, Lot Number 19JDC293 ; C040100, Lot Number 19LDB582 ; C040100, Lot Number 20BDA227 ; C040100, Lot Number 20BDA828 ; C040100, Lot Number 20BDC639 ; C040100, Lot Number 20DDA503 ; C040100, Lot Number 20DDA627 ; C040100, Lot Number 20HDC033 ; C040100, Lot Number 21HDA277 ; C040100, Lot Number 22EDB968 ; C040100, Lot Number 22HDB951 ; CDS760049AD, Lot Number 21IBC904 ; CDS760049AD, Lot Number 21IBM329 ; CDS760049AD, Lot Number 21LBS989 ; CDS760049AD, Lot Number 22CBW119 ; CDS760049AD, Lot Number 22OBL416 ; CDS760049AD, Lot Number 22OBL970 ; CDS760049AD, Lot Number 22GBD274 ; CDS760049AD, Lot Number 22IBF092 ; CDS760049AD, Lot Number 22JBF094 ; CDS760049AD, Lot Number 22KBF472 ; CDS760049AD, Lot Number 22KBI850 ; CDS760049AD, Lot Number 23AB

code_info

C040100, Lot Number 19BDB794 ; C040100, Lot Number 19BDB938 ; C040100, Lot Number 19CDD009 ; C040100, Lot Number 19E…

C040100, Lot Number 19BDB794 ; C040100, Lot Number 19BDB938 ; C040100, Lot Number 19CDD009 ; C040100, Lot Number 19EDC262 ; C040100, Lot Number 19EDC533 ; C040100, Lot Number 19JDA569 ; C040100, Lot Number 19JDA836 ; C040100, Lot Number 19JDC293 ; C040100, Lot Number 19LDB582 ; C040100, Lot Number 20BDA227 ; C040100, Lot Number 20BDA828 ; C040100, Lot Number 20BDC639 ; C040100, Lot Number 20DDA503 ; C040100, Lot Number 20DDA627 ; C040100, Lot Number 20HDC033 ; C040100, Lot Number 21HDA277 ; C040100, Lot Number 22EDB968 ; C040100, Lot Number 22HDB951 ; CDS760049AD, Lot Number 21IBC904 ; CDS760049AD, Lot Number 21IBM329 ; CDS760049AD, Lot Number 21LBS989 ; CDS760049AD, Lot Number 22CBW119 ; CDS760049AD, Lot Number 22OBL416 ; CDS760049AD, Lot Number 22OBL970 ; CDS760049AD, Lot Number 22GBD274 ; CDS760049AD, Lot Number 22IBF092 ; CDS760049AD, Lot Number 22JBF094 ; CDS760049AD, Lot Number 22KBF472 ; CDS760049AD, Lot Number 22KBI850 ; CDS760049AD, Lot Number 23AB

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3049-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.