MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-3030-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY, Pack Number MNS5070; 3) BREAST BIOPSY TRAY-LF, Pack Number SPEC0058A; 4) BREAST BIOPSY TRAY, Pack Number DYNDH1142A; 5) BREAST BIOPSY TRAY, Pack Number SPEC0130B; 6) BIOPSY PACK SM, Pack Number DYNDH1093; 7) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 8) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A; 9) LACERATION TRAY, Pack Number DYNDL1250C; 10) PULL D/C PACK, Pack Number DYNDA2080; 11) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 12) OB DELIVERY SET, Pack Number MNS3355; 13) SUTURING SET, Pack Number SUT4020; 14) 22G FACET TRAY, Pack Number SPEC0265A; 15) ARTHROGRAM TRAY, Pack Number DYNDH1349; 16) BIOPSY TRAY W/O LIDOCAINE, Pack Number SPEC0196B; 17) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496; 18) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 19) DELIVERY ACCESSORY KIT, Pack Number MNS6496; 20) BREAST BIOPSY KIT, Pack Number DYNDH1706; 21) BIOPSY TRAY - LF, Pack Number DYNJTS0018A; 22) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 23) STEREOTACTIC BREAST BIOPSY TRAY, Pack Number DYNDH1755; 24) BREAST BIOPSY, Pack Number DYNDH1518A; 25) PORT INSERTION KIT, Pack Number MNS11590; 26) CORE BIOPSY TRAY, Pack Number SPEC0083B; 27) INFUSION CENTER BLOOD DRAW KIT, Pack Number DYNDH1798; 28) BREAST CENTER BIOPSY TRAY, Pack Number DYNDH1519; 29) AULTMAN HOSPITAL CHEST TUBE INSERTION TR, Pack Number CHT500; 30) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 31) ARTHROGRAM TRAY, Pack Number DYNDH1134; 32) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 33) BIOPSY TRAY, Pack Number DYNDH1269; 34) BIOPSY BASIC PACK, Pack Number DYNDH1588

Product Classification:

Class II

Date Initiated: April 8, 2024

Date Posted: September 18, 2024

Recall Number: Z-3030-2024

Event ID: 94583

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.

Status: Ongoing

Product Quantity:

Code Information:

BT1095 , Lot Number 21HBO851 ; BT1095 , Lot Number 21JBA498 ; BT1095 , Lot Number 21KBS041 ; BT1095 , Lot Number 21LBI316 ; BT1095 , Lot Number 22IBE255 ; BT1095 , Lot Number 23CBL036 ; BT1095 , Lot Number 23DBE633 ; BT1095 , Lot Number 21ABU603 ; MNS5070, Lot Number 23LBC489; MNS5070, Lot Number 23HBL700; MNS5070, Lot Number 23EBJ365; SPEC0058A, Lot Number 2018110290; DYNDH1142A, Lot Number 2018120590; SPEC0130B, Lot Number 2018121290; SPEC0058A, Lot Number 2019012490; DYNDH1093, Lot Number 2019012490; SPEC0130B, Lot Number 2019020590; DYNDH1227A, Lot Number 2019020590; DYNDH1304A, Lot Number 2019040990; DYNDL1250C, Lot Number 2019040990; DYNDH1227A, Lot Number 2019040990; DYNDL1250C, Lot Number 2019040990; DYNDA2080, Lot Number 2019040990; SPEC0058A, Lot Number 2019060690; SPEC0130B, Lot Number 2019062890; SPEC0058A, Lot Number 2019070290; DYNDH1359, Lot Number 2019070290; MNS3355, Lot Number 2019062890; SPEC0130B, Lot Number 2019081590; SUT4020, Lot Number 2019081590; SPEC0265A, Lot Number 2019081590; DYNDH1349, Lot Number 2019081590; DYNDH1304A, Lot Number 2019112190; SPEC0196B, Lot Number 2019112190; DYNDH1349, Lot Number 2019112190; SPEC0130B, Lot Number 2019121190; DYNDH1496, Lot Number 2019122790; DYNDH1496, Lot Number 2020013190; DYNDH1496, Lot Number 2020120290; DYNDH1496, Lot Number 2021022590; SPEC0130C, Lot Number 2021051890; MNS6496, Lot Number 2021051890; SPEC0130C, Lot Number 2021071290; SPEC0130C, Lot Number 2021082490; SPEC0130C, Lot Number 2021091390; DYNDH1706, Lot Number 2022021550; SPEC0130C, Lot Number 2022020290; SPEC0130C, Lot Number 2022032990; DYNJTS0018A, Lot Number 2022032990; DYNDC2859A, Lot Number 2022032990; DYNDH1755, Lot Number 2022061050; DYNDH1518A, Lot Number 2022061050; SPEC0130C, Lot Number 2022081690; SPEC0130C, Lot Number 2022120290; MNS11590, Lot Number 2022120290; SPEC0083B, Lot Number 2022120290; DYNDH1798, Lot Number 2022120290; DYNDH1519, Lot Number 2022120690; CHT500, Lot Number 2022120690; DYNDH1519, Lot Number 2023020390; SPEC0130C, Lot Number 2023053190; DYNDH1519, Lot Number 2023081590; DYNDH1257, Lot Number 2018072450; DYNDH1257, Lot Number 2018080950; DYNDH1257, Lot Number 2018100350; DYNDH1257, Lot Number 2018113050; DYNDH1134, Lot Number 2018113050; DYNDH1319, Lot Number 2019011750; DYNDH1257, Lot Number 2019032150; DYNDH1319, Lot Number 2019073050; DYNDH1319, Lot Number 2019093050; DYNDH1319, Lot Number 2019103150; DYNDH1257, Lot Number 2020020350; DYNDH1257, Lot Number 2020033150; DYNDH1319, Lot Number 2020072050; DYNDH1269, Lot Number 2020072050; DYNDH1257, Lot Number 2020102950; DYNDH1319, Lot Number 2021021950; DYNDH1257, Lot Number 2021030350; DYNDH1257, Lot Number 2021120750; DYNDH1257, Lot Number 2022051350; DYNDH1319, Lot Number 2022052650; DYNDH1588, Lot Number 2022052650

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated