Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA — Class II medical device recall Z-3030-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-09-18. Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. L
| Recall number | Z-3030-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-04-08 |
| Classified | 2024-09-06 |
| Reported by FDA | 2024-09-18 |
| Reason classes | packaging, device malfunction |
| Lot numbers | 2018072450, 2018080950, 2018100350, 2018110290, 2018113050, 2018120590, 2018121290, 2019011750, 2019012490, 2019020590, 2019032150, 2019040990, 2019060690, 2019062890, 2019070290, 2019073050, 2019081590, 2019093050, 2019103150, 2019112190, 2019121190, 2019122790, 2020013190, 2020020350, 2020033150, 2020072050, 2020102950, 2020120290, 2021021950, 2021022590, 2021030350, 2021051890, 2021071290, 2021082490, 2021091390, 2021120750, 2022020290, 2022021550, 2022032990, 2022051350 and 53 more |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3030-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.