Medline Probe Cover Kits containing sterile Ultrasound Gel — Class II medical device recall Z-2181-2023
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-2181-2023 |
|---|---|
| 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 | 3,740,814 units |
| UPC / GTIN / UDI-DI | 10193489373745, 10193489472813, 10193489476736, 10193489682724, 10193489842845, 10195327176891, 10195327223564, 10653160307662, 10653160322139, 10653160330752, 10653160343455, 10653160990154, 10653160990260, 10816982023374, 10889942906802, 10889942945887, 40193489373746, 40193489472814, 40193489476737, 40193489682725, 40193489842846, 40195327176892, 40195327223565, 40653160307663, 40653160322130 and 7 more |
| Model numbers | DYNJRA1755, DYNJTESTCFP4, IV8635D, IVS3300, IVS3485A, IVS3825, IVS3840A, MNS11625, MNS7695A, NG410A, PHS41739A, PHS479840M, SYNJ10303B, TVS4500A, TVS4500B |
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4; c) ULTRASOUND PIV BUNDLE, Model Number IV8635D; d) ULTRASOUND GUIDED PIV KIT, Model Number IVS3300; e) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3485A; f) EPIV PROCEDURE TRAY, Model Number IVS3825; g) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3840A; h) RADIOLOGY TRAY, Model Number MNS11625; i) BEDSIDE PROCEDURE PREP KIT, Model Number MNS7695A; j) NGHS EVOR ANGIO PACK, Model Number NG410A; k) PICC INSERT KIT-LESS THAN 3 FR, Model Number PHS41739A; l) RADIOLOGY SPECIALS PACK, Model Number PHS479840M; m) HYBRID OR PACK, Model Number SYNJ10303B; n) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500A; o) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500B; p) VC PROCEDURE KIT, Model Number VC-PK
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-2181-2023. 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.