Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pac... — FDA record Z-2998-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ; 3) BIOPSY DRAPE PACK , Pack Number 00-400762H ; 4) BIOPSY PROCEDURE PACK , Pack Number 00-400832N ; 5) BIOPSY PROCEDURE PACK , Pack Number 00-400832O ; 6) BIOPSY PROCEDURE PACK , Pack Number 00-400832P ; 7) BIOPSY PROCEDURE PACK , Pack Number 00-401261F ; 8) 6" FEMORAL ARTERIALLINE KIT, Pack Number ART245B; 9) BREAST BIOPSY KIT , Pack Number BT1085A; 10) BREAST BIOPSY PROCEDURE TRAY, Pack Number BX8375F; 11) BREAST/MINOR, Pack Number CDS980228X ; 12) BIOPSY CDS-LF , Pack Number CDS984667D ; 13) BIOPSY CDS-LF , Pack Number CDS984667F ; 14) BREAST-HERNIA-PORT CDS-LF , Pack Number CDS984853G ; 15) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 16) QSUM STEREO/US BIOPSY TRAY, Pack Number CT101; 17) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960; 18) BIOPSY DEKALB PACK, Pack Number DM150A ; 19) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 20) COLONOSCOPY KIT , Pack Number DYKE1218 ; 21) BREAST BIOPSY KIT , Pack Number DYNDA1224B ; 22) TDC REMOVAL, Pack Number DYNDA1633A; 23) BREAST BIOPSY PACK, Pack Number DYNDA2378A ; 24) CUSTOM BIOPSY TRAY, Pack Number DYNDA2448; 25) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 26) BIOPSY/MYELOGRAM PACK, Pack Number DYNDA2655; 27) PICU LINE TRAY, Pack Number DYNDC1960A; 28) PORT ACCESS KIT, Pack Number DYNDC2945; 29) CT BIOPSY TRAY, Pack Number DYNDH1054; 30) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108; 31) BIOPSY PACK , Pack Number DYNDH1110; 32) ARTHROGRAM TRAY, Pack Number DYNDH1113; 33) BIOPSY TRAY , Pack Number DYNDH1114; 34) BIOPSY TRAY, Pack Number DYNDH1129; 35) ARTHROGRAM TRAY, Pack Number DYNDH1134; 36) BIOPSY PACK , Pack Number DYNDH1137A ; 37) BREAST BIOPSY TRAY, Pack Number DYNDH1142C ; 38) BREAST BIOPSY TRAY, Pack Number DYNDH1152A ; 39) BIOPSY KIT, Pack Number DYNDH1156; 40) ULTRASOUND TRAY, Pack Number DYNDH1204; 41) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 42) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 43) CORE BIOPSY TRAY, Pack Number DYNDH1233; 44) BIOPSY PACK, Pack Number DYNDH1248; 45) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 46) BREAST BIOPSY TRAY, Pack Number DYNDH1266; 47) GENERAL BIOPSY TRAY , Pack Number DYNDH1268; 48) BIOPSY TRAY, Pack Number DYNDH1269; 49) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270; 50) DB CT BIOPSY TRAY -LF , Pack Number DYNDH1270; 51) BIOPSY TRAY , Pack Number DYNDH1273; 52) BIOPSY PACK TAA COMPLIANT , Pack Number DYNDH1294; 53) BREAST BIOPSY TRAY, Pack Number DYNDH1296B ; 54) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 55) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 56) ISHAK IR DRAINAGE TRAY, Pack Number DYNDH1300; 57) BREAST BIOPSY TRAY, Pack Number DYNDH1302; 58) BREAST BIOPSY TRAY, Pack Number DYNDH1302H ; 59) BIOPSY TRAY, Pack Number DYNDH1314; 60) BIOPSY TRAY , Pack Number DYNDH1314A ; 61) MAMMOGRAPHY BREAST BIOPSY, Pack Number DYNDH1318; 62) ULTRASOUND GUIDE BREAST BIOPSY, Pack N...
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.
Classification
Class II
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
Not supplied
Agency-reported status
Ongoing
Source record identifier
Z-2998-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability00-400162J, Lot Number 24BMJ154; 00-400162J , Lot Number 21HBM269 ; 00-400162J , Lot Number 21IBK734 ; 00-400162J , Lot Number 21VBB786 ; 00-400162J , Lot Number 21KBS936 ; 00-400162J , Lot Number 21LBA763 ; 00-400162J , Lot Number 22ABN222 ; 00-400162J , Lot Number 19ABM483 ; 00-400162J , Lot Number 19BBI451 ; 00-400162J , Lot Number 19CBM173 ; 00-400162J , Lot Number 19DBL959 ; 00-400162J , Lot Number 22FBO944 ; 00-400162J , Lot Number 19FBG533 ; 00-400162J , Lot Number 22JBB402 ; 00-400162J , Lot Number 19TBB201 ; 00-400162J , Lot Number 22KBV632 ; 00-400162J , Lot Number 19JBD745 ; 00-400162J , Lot Number 19KBI828 ; 00-400162J , Lot Number 19LBK452 ; 00-400162J , Lot Number 23CBO907 ; 00-400162J , Lot Number 19LBY367 ; 00-400162J , Lot Number 20ABQ389 ; 00-400162J , Lot Number 23FBG349 ; 00-400162J , Lot Number 20CBV380 ; 00-400162J , Lot Number 20DBI320 ; 00-400162J , Lot Number 23IBF372 ; 00-400162J , Lot Number 20FBQ675 ; 00-400162J , Lot Number 20GBO378 ; 00-400162J , Lot Number 20JBH095 ; 00-400162J , Lot Number 20JBL452 ; 00-400162J , Lot Number 20JBX151 ; 00-400162J , Lot Number 20KBZ223 ; 00-400162J , Lot Number 20XBA215 ; 00-400162J , Lot Number 21DBB680 ; 00-400162J , Lot Number 24AMB898 ; 00-400405C , Lot Number 21KBM812 ; 00-400405C , Lot Number 21LBT408 ; 00-400405C , Lot Number 21LBT899 ; 00-400405C , Lot Number 19ABL059 ; 00-400405C , Lot Number 19BBB783 ; 00-400405C , Lot Number 19CBC868 ; 00-400405C , Lot Number 19KBY105 ; 00-400405C , Lot Number 19LBB184 ; 00-400762H , Lot Number 21HBR227 ; 00-400832N , Lot Number 19BDA790 ; 00-400832N , Lot Number 19BDD147 ; 00-400832N , Lot Number 19DDB220 ; 00-400832N , Lot Number 19FDA964 ; 00-400832O , Lot Number 19IDA318 ; 00-400832O , Lot Number 19KMA743 ; 00-400832O , Lot Number 19KMC836 ; 00-400832O , Lot Number 20BMA017 ; 00-400832O , Lot Number 20CMB031 ; 00-400832O , Lot Number 20FMB526 ; 00-400832O , Lot Number 20HMC867 ; 00-400832O , Lot Number 20JMB320 ; 00-400832O , Lot Number 21AMC858 ; 00-400832O , Lot Number 21FMA865 ; 00-400832O , Lot Number 21HMB368 ; 00-400832O , Lot Number 21JMA868 ; 00-400832O , Lot Number 22AME715 ; 00-400832O , Lot Number 22CMA957 ; 00-400832P , Lot Number 23LBL872 ; 00-400832P , Lot Number 22EMF901 ; 00-400832P , Lot Number 22GMD199 ; 00-400832P , Lot Number 22HME947 ; 00-400832P , Lot Number 22JMA494 ; 00-400832P , Lot Number 22KMD610 ; 00-400832P , Lot Number 23AMB199 ; 00-400832P , Lot Number 23CMD961 ; 00-400832P , Lot Number 23EMD513 ; 00-400832P , Lot Number 23FMH541 ; 00-400832P , Lot Number 23GMH251 ; 00-400832P , Lot Number 23IMA234 ; 00-400832P , Lot Number 23KMA301 ; 00-401261F , Lot Number 19DDD151 ; ART245B, Lot Number 2023050490; BT1085A, Lot Number 21JBW716 ; BT1085A, Lot Number 22EBN971 ; BT1085A, Lot Number 22IBO409 ; BT1085A, Lot Number 22KBQ151 ; BT1085A, Lot Number 22LBS928 ; BT1085A, Lot Number 23EBQ469 ; BT1085A, Lot Number 23HBA899 ; BT1085A, Lot Number 23HBM503 ; BT1085A, Lot Number 23LBP500 ; BX8375F, Lot Number 19BBQ976 ; CDS980228X , Lot Number 21IBJ198 ; CDS980228X , Lot Number 21IBL102 ; CDS980228X , Lot Number 21IBT611 ; CDS980228X , Lot Number 21KBA518 ; CDS980228X , Lot Number 22CBT672 ; CDS980228X , Lot Number 22OBL706 ; CDS980228X , Lot Number 22EBN150 ; CDS980228X , Lot Number 22GBJ007 ; CDS980228X , Lot Number 22GBJ522 ; CDS980228X , Lot Number 22GBU493 ; CDS980228X , Lot Number 22HBO646 ; CDS980228X , Lot Number 22JBH336 ; CDS980228X , Lot Number 22KBI846 ; CDS980228X , Lot Number 23BBB687 ; CDS980228X , Lot Number 23BBB770 ; CDS980228X , Lot Number 23CBQ216 ; CDS980228X , Lot Number 23EBG155 ; CDS980228X , Lot Number 23FBH110 ; CDS980228X , Lot Number 23FBU678 ; CDS980228X , Lot Number 23HBK342 ; CDS980228X , Lot Number 23IBM309 ; CDS980228X , Lot Number 23KBN911 ; CDS980228X , Lot Number 23LBQ885 ; CDS980228X , Lot Number 24ABV909 ; CDS984667D , Lot Number 19ABX202 ; CDS984667D , Lot Number 19CBJ247 ; CDS984667D , Lot Number 19EBK219 ; CDS984667D , Lot Number 19GBH803 ; CDS984667D , Lot Number 19HBM191 ; CDS984667D , Lot Number 19KBR426 ; CDS984667D , Lot Number 20BBD375 ; CDS984667D , Lot Number 20BBW882 ; CDS984667D , Lot Number 20FBL632 ; CDS984667D , Lot Number 20HBI802 ; CDS984667D , Lot Number 20JBH644 ; CDS984667D , Lot Number 21ABW316 ; CDS984667D , Lot Number 21BBO832 ; CDS984667F , Lot Number 21HBI147 ; CDS984667F , Lot Number 21HBQ079 ; CDS984667F , Lot Number 21IBC923 ; CDS984667F , Lot Number 21JBC107 ; CDS984667F , Lot Number 21JBM708 ; CDS984667F , Lot Number 21LBG294 ; CDS984667F , Lot Number 22NBF721 ; CDS984667F , Lot Number 22OBJ844 ; CDS984667F , Lot Number 21EBC591 ; CDS984667F , Lot Number 22FMH829 ; CDS984667F , Lot Number 22HMA231 ; CDS984667F , Lot Number 22JMB506 ; CDS984667F , Lot Number 22JMG035 ; CDS984667F , Lot Number 22KMC059 ; CDS984667F , Lot Number 22LME009 ; CDS984667F , Lot Number 23AMF563 ; CDS984667F , Lot Number 23CMD811 ; CDS984667F , Lot Number 23CMG538 ; CDS984667F , Lot Number 23FMC037 ; CDS984667F , Lot Number 23GMA593 ; CDS984853G , Lot Number 21JDB293 ; CDS984853G , Lot Number 21KDB427 ; CDS984853G , Lot Number 21LDA306 ; CIT6785A, Lot Number 2021111990; CT101, Lot Number 22HBM599; CT101, Lot Number 22GBL378; CT101, Lot Number 22FBU522; CT101, Lot Number 22CBV047; CT101, Lot Number 22BBP535; CT101, Lot Number 21HBC220; CVI4960, Lot Number 2023061490; DM150A , Lot Number 19ABE922 ; DM150A , Lot Number 19ABI891 ; DM150A , Lot Number 19CBE170 ; DM150A , Lot Number 19CBL567 ; DM150A , Lot Number 19DBU214 ; DM150A , Lot Number 19GBA025 ; DM150A , Lot Number 19GBZ648 ; DM150A , Lot Number 19IBM291 ; DM150A , Lot Number 20BBY500 ; DM150A , Lot Number 20DBC998 ; DM150A , Lot Number 20EBJ718 ; DM150A , Lot Number 20GBK855 ; DM150A , Lot Number 20HBD401 ; DM150A , Lot Number 20KBC120 ; DM150A , Lot Number 20XBD159 ; DM645, Lot Number 2019090380; DYKE1218 , Lot Number 21LMG689 ; DYNDA1224B , Lot Number 23KMG399 ; DYNDA1633A, Lot Number 2021070650; DYNDA2378A , Lot Number 21JBR470 ; DYNDA2448, Lot Number 21JBC950 ; DYNDA2497, Lot Number 2019060550; DYNDA2497, Lot Number 2019062050; DYNDA2655, Lot Number 22OBC046; DYNDA2655, Lot Number 22CBX719; DYNDA2655, Lot Number 22DBB515 ; DYNDA2655, Lot Number 23EBK488 ; DYNDA2655, Lot Number 23EBR534 ; DYNDA2655, Lot Number 23FBK774 ; DYNDA2655, Lot Number 23GBD758 ; DYNDA2655, Lot Number 23GBQ973 ; DYNDA2655, Lot Number 23IBJ592 ; DYNDA2655, Lot Number 24ABC341 ; DYNDC1960A, Lot Number 2019062050; DYNDC2945, Lot Number 2022092990; DYNDH1054, Lot Number 2018071250; DYNDH1108, Lot Number 21IBS645 ; DYNDH1108, Lot Number 21JBY809 ; DYNDH1108, Lot Number 22BBG422 ; DYNDH1108, Lot Number 19ABR481 ; DYNDH1108, Lot Number 19DBI234 ; DYNDH1108, Lot Number 19EBL436 ; DYNDH1108, Lot Number 19EBL551 ; DYNDH1108, Lot Number 20CBU457 ; DYNDH1108, Lot Number 20GBI404 ; DYNDH1108, Lot Number 20JBI282 ; DYNDH1108, Lot Number 20KBT996 ; DYNDH1108, Lot Number 21ABS179 ; DYNDH1108, Lot Number 21CBV898 ; DYNDH1108, Lot Number 21DBG359 ; DYNDH1108, Lot Number 21EBQ401 ; DYNDH1108, Lot Number 22CMC304 ; DYNDH1108, Lot Number 22EMI535 ; DYNDH1108, Lot Number 22FMG345 ; DYNDH1108, Lot Number 22JME999 ; DYNDH1108, Lot Number 23BMA505 ; DYNDH1108, Lot Number 23DMD916 ; DYNDH1108, Lot Number 23EMH904 ; DYNDH1108, Lot Number 23FMD384 ; DYNDH1108, Lot Number 23FMI958 ; DYNDH1108, Lot Number 23IMI347 ; DYNDH1108, Lot Number 23JMH539 ; DYNDH1108, Lot Number 23LMB050 ; DYNDH1110, Lot Number 21JBI819 ; DYNDH1113, Lot Number 2019100950; DYNDH1114, Lot Number 21JBQ576 ; DYNDH1129, Lot Number 2018061450; DYNDH1129, Lot Number 2019011450; DYNDH1129, Lot Number 2019062050; DYNDH1129, Lot Number 2019080250; DYNDH1129, Lot Number 2019100150; DYNDH1134, Lot Number 2018091050; DYNDH1137A , Lot Number 19CBQ763 ; DYNDH1142C , Lot Number 21KBT970 ; DYNDH1142C , Lot Number 22BBG396 ; DYNDH1142C , Lot Number 21CBL686 ; DYNDH1142C , Lot Number 21CBM797 ; DYNDH1142C , Lot Number 22FMA927 ; DYNDH1142C , Lot Number 23AMJ692 ; DYNDH1142C , Lot Number 23CMA358 ; DYNDH1142C , Lot Number 23DMC945 ; DYNDH1142C , Lot Number 23FMF669 ; DYNDH1142C , Lot Number 23KMA966 ; DYNDH1142C , Lot Number 23LMB042 ; DYNDH1152A , Lot Number 21JBM609 ; DYNDH1156, Lot Number 21JBR523 ; DYNDH1204, Lot Number 2018062950; DYNDH1227A, Lot Number 2019050890; DYNDH1227B, Lot Number 2022021190; DYNDH1227B , Lot Number 20FBK116 ; DYNDH1227B , Lot Number 20HBB805 ; DYNDH1227B , Lot Number 20IBF887 ; DYNDH1233, Lot Number 21JBP011 ; DYNDH1248, Lot Number 2018071850; DYNDH1257, Lot Number 2019011450; DYNDH1257, Lot Number 2019021850; DYNDH1257, Lot Number 2019092450; DYNDH1257, Lot Number 2019101450; DYNDH1257, Lot Number 2019110450; DYNDH1266, Lot Number 21JBR760 ; DYNDH1268, Lot Number 21JBR420 ; DYNDH1269, Lot Number 2018061450; DYNDH1269, Lot Number 2020012350; DYNDH1269, Lot Number 22GBP946 ; DYNDH1269, Lot Number 22IBH093 ; DYNDH1269, Lot Number 23BBI257 ; DYNDH1269, Lot Number 23DBK823 ; DYNDH1269, Lot Number 23GBA153 ; DYNDH1269, Lot Number 23JBJ925 ; DYNDH1269, Lot Number 24ABW151 ; DYNDH1270, Lot Number 2019031490; DYNDH1270, Lot Number 2019050890; DYNDH1270, Lot Number 2019072290; DYNDH1270, Lot Number 21IBG275 ; DYNDH1270, Lot Number 21IBG292 ; DYNDH1270, Lot Number 21IBG556 ; DYNDH1270, Lot Number 21LBS564 ; DYNDH1270, Lot Number 22DBA102 ; DYNDH1270, Lot Number 22EBN016 ; DYNDH1270, Lot Number 19HBK811 ; DYNDH1270, Lot Number 22JBH169 ; DYNDH1270, Lot Number 22KBP080 ; DYNDH1270, Lot Number 22KBU728 ; DYNDH1270, Lot Number 23CBN975 ; DYNDH1270, Lot Number 20ABJ527 ; DYNDH1270, Lot Number 23EBP053 ; DYNDH1270, Lot Number 20BBY926 ; DYNDH1270, Lot Number 20BBZ444 ; DYNDH1270, Lot Number 20CBB656 ; DYNDH1270, Lot Number 23HBX369 ; DYNDH1270, Lot Number 20FBB439 ; DYNDH1270, Lot Number 23JBP702 ; DYNDH1270, Lot Number 23KBH402 ; DYNDH1270, Lot Number 20HBA149 ; DYNDH1270, Lot Number 20JBP109 ; DYNDH1270, Lot Number 20LBU089 ; DYNDH1270, Lot Number 21ABN463 ; DYNDH1270, Lot Number 21BBO653 ; DYNDH1270, Lot Number 21CBZ193 ; DYNDH1270, Lot Number 21EBQ153 ; DYNDH1273, Lot Number 20CBF416 ; DYNDH1273, Lot Number 20EBS909 ; DYNDH1273, Lot Number 20FBW150 ; DYNDH1273, Lot Number 20HBQ625 ; DYNDH1273, Lot Number 20IBC072 ; DYNDH1294, Lot Number 21JBZ911 ; DYNDH1294, Lot Number 22FME565 ; DYNDH1294, Lot Number 22HMG282 ; DYNDH1294, Lot Number 23BMA464 ; DYNDH1294, Lot Number 23BMG476 ; DYNDH1294, Lot Number 23HMF973 ; DYNDH1294, Lot Number 23JMA389 ; DYNDH1294, Lot Number 23JMF679 ; DYNDH1296B , Lot Number 21JBK568 ; DYNDH1297, Lot Number 2019060550; DYNDH1297, Lot Number 22GBO343 ; DYNDH1297, Lot Number 22JBI828 ; DYNDH1297, Lot Number 22LBK229 ; DYNDH1297, Lot Number 23EBI256 ; DYNDH1297, Lot Number 23GBE050 ; DYNDH1297, Lot Number 23LBQ777 ; DYNDH1300, Lot Number 2018061450; DYNDH1302, Lot Number 21JBQ374 ; DYNDH1302H , Lot Number 21JBQ374 ; DYNDH1314, Lot Number 2018052950; DYNDH1314, Lot Number 2018071850; DYNDH1314, Lot Number 2018080250; DYNDH1314, Lot Number 2018081550; DYNDH1314A , Lot Number 19CAB562 ; DYNDH1318, Lot Number 2019011050; DYNDH1319, Lot Number 2018102650; DYNDH1324, Lot Number 2019011850; DYNDH1328, Lot Number 22HMA359; DYNDH1328, Lot Number 22FME915; DYNDH1328, Lot Number 22DMA781; DYNDH1328, Lot Number 21JBN313 ; DYNDH1328, Lot Number 23JMJ203 ; DYNDH1328, Lot Number 23KMH462 ; DYNDH1328, Lot Number 23LMF075 ; DYNDH1355A , Lot Number 19BAB620 ; DYNDH1355A , Lot Number 19DAA066 ; DYNDH1355A , Lot Number 19DAB614 ; DYNDH1355A , Lot Number 19EAB062 ; DYNDH1355A , Lot Number 19FAB229 ; DYNDH1376A , Lot Number 21JBF339 ; DYNDH1425, Lot Number 21JBI203 ; DYNDH1430A , Lot Number 23GBF746 ; DYNDH1430A , Lot Number 23HBV750 ; DYNDH1434, Lot Number 21FBO653 ; DYNDH1434, Lot Number 21KBH014 ; DYNDH1434, Lot Number 21LBB156 ; DYNDH1434, Lot Number 22ABJ623 ; DYNDH1434, Lot Number 22ABK656 ; DYNDH1434, Lot Number 23GBI830 ; DYNDH1434, Lot Number 20JBP719 ; DYNDH1434, Lot Number 21BBE028 ; DYNDH1434, Lot Number 21EBO430 ; DYNDH1477, Lot Number 21HBR113 ; DYNDH1477, Lot Number 21VBD398 ; DYNDH1477, Lot Number 22DBD051 ; DYND...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date
Sep 18, 2024
Recall initiation date
Apr 8, 2024
Center classification date
Sep 6, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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