Medline Probe Cover Kits containing sterile Ultrasound Gel — Class II medical device recall Z-2170-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-07-26, distributed nationwide. Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
| Recall number | Z-2170-2023 |
|---|---|
| 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 | 2023-05-18 |
| Classified | 2023-07-20 |
| Reported by FDA | 2023-07-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CN, CR, IN, LB, PA, QA, SA, SG |
| Quantity | 47,185 units |
| UPC / GTIN / UDI-DI | 10193489197082, 10193489326451, 10193489348798, 10193489368802, 10193489405590, 10193489432282, 10193489468519, 10193489468656, 10193489598575, 10193489682267, 10193489825312, 10193489897197, 10195327010683, 10195327037239, 10195327044480, 10195327080624, 10195327088705, 10195327088729, 10195327164744, 10195327166427, 10195327228477, 10195327235710, 10195327251475, 10195327292294, 10195327292652 and 51 more |
| Model numbers | DYNDA1224B, DYNDH1121C, DYNDH1124, DYNDH1147A, DYNDH1266, DYNDH1345A, DYNDH1496A, DYNDH1534, DYNDH1542B, DYNDH1670, DYNDH1677, DYNDH1748, DYNDH1750, DYNDH1750A, DYNDH1778, DYNDH1822, DYNDH1828, DYNJ0747885G, DYNJ34637G, DYNJ38616A, DYNJ42307A, DYNJ42752A, DYNJ43076, DYNJ43076A, DYNJ50485 and 13 more |
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE BIOPSY KIT, Model Number DYNDH1121C; c) BIOPSY PACK, Model Number DYNDH1124; d) REVAMP BIOPSY TRAY, Model Number DYNDH1147A; e) BREAST BIOPSY TRAY, Model Number DYNDH1266; f) BREAST BIOPSY TRAY, Model Number DYNDH1345A; g) ULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A; h) BASIC BIOPSY TRAY, Model Number DYNDH1534; i) ULTRASOUND BIOPSY, Model Number DYNDH1542B; j) CABARRUS BIOPSY TRAY, Model Number DYNDH1670; k) BREAST BIOPSY TRAY, Model Number DYNDH1677; l) NORTH PARK BIOPSY TRAY, Model Number DYNDH1748; m) SOFT TISSUE BIOPSY, Model Number DYNDH1750; n) SOFT TISSUE BIOPSY, Model Number DYNDH1750A; o) UL BIOPSY TRAY, Model Number DYNDH1778; p) BREAST BIOPSY KIT, Model Number DYNDH1822; q) ULTRASOUND BIOPSY, Model Number DYNDH1828; r) BIOPSY PACK-LF, Model Number DYNJ0747885G; s) BIOPSY TRAY, Model Number DYNJ34637G; t) IGT BIOPSY PACK-LF, Model Number DYNJ38616A; u) BIOPSY WITH PROB COVER WRO-LF, Model Number DYNJ42307A; v) CORE BIOPSY PACK-LF, Model Number DYNJ42752A; w) BIOPSY TRAY, Model Number DYNJ43076; x) BIOPSY TRAY, Model Number DYNJ43076A; y) BIOPSY PACK, Model Number DYNJ50485; z) ABLATION/DRAINAGE PACK, Model Number DYNJ53658B; aa) BIOPSY RAD CT, Model Number DYNJ59752A; bb) US BREAST BIOPSY PACK, Model Number DYNJ61992B; cc) US BREAST BIOPSY PACK, Model Number DYNJ61992C; dd) BIOPSY TRAY, Model Number DYNJ62690; ee) IR BIOPSY PACK, Model Number DYNJ63688A; ff) IR BIOPSY PACK, Model Number DYNJ63688B; gg) IR BIOPSY PACK, Model Number DYNJ63688C; hh) IR BIOPSY PACK, Model Number DYNJ63688G; ii) IR BIOPSY PACK, Model Number DYNJ63688I; jj) INSERTION PACK, Model Number DYNJ83149; kk) GENERAL BIOPSY PACK, Model Number P365500; ll) RENAL BIOPSY TRAY, Model Number SPEC0168;
Reason for recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
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-2170-2023. 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.