Medline Probe Cover Kits containing sterile Ultrasound Gel — Class II medical device recall Z-2169-2023
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-2169-2023 |
|---|---|
| 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 | 770,147 units |
| UPC / GTIN / UDI-DI | 10193489280371, 10193489306859, 10193489355345, 10193489365030, 10193489378214, 10193489783872, 10195327196806, 10195327198640, 10195327289904, 10195327313494, 10195327320423, 10195327320829, 10195327351144, 10195327355296, 10888277778696, 10888277786455, 10888277903463, 10889942245352, 10889942415113, 40193489280372, 40193489306850, 40193489355346, 40193489365031, 40193489378215, 40193489783873 and 13 more |
| Model numbers | CDS840214Q, DYNDA2418, DYNJ0365463J, DYNJ24459P, DYNJ40629B, DYNJ44210B, DYNJ47716C, DYNJ48520, DYNJ53059A, DYNJ59813, DYNJ61747C, DYNJ68027A, DYNJ81410B, DYNJ82517, DYNJ83966, DYNJ906915, DYNJ908046C, PHS751646C, PHS751646D |
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYNDA2418; c) CLOSUREFAST PROCEDURE PACK-LF, Model Number DYNJ0365463J; d) BARIATRIC PACK, Model Number DYNJ24459P; e) ABLATION PACK, Model Number DYNJ40629B; f) ENDOLUMINAL ACCESSORY PACK, Model Number DYNJ44210B; g) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716C; h) EVLT SURGICAL PACK, Model Number DYNJ48520; i) MAXIMAL BARRIER BEDSIDE PACK, Model Number DYNJ53059A; j) LAPAROSCOPY PACK, Model Number DYNJ59813; k) PORT PACK, Model Number DYNJ61747C; l) RR-BRACHY PACK, Model Number DYNJ68027A; m) AV FISTULA PACK, Model Number DYNJ81410B; n) ECMO PACK-LF, Model Number DYNJ82517; o) SYNERGY PROCEDURE PACK, Model Number DYNJ83966; p) MINOR, Model Number DYNJ906915; q) PROCEDURE PACK DR BILIMORI, Model Number DYNJ908046C; r) ULTRASOUND PACK-LF, Model Number PHS751646C; s) ULTRASOUND PACK-LF, Model Number PHS751646D;
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-2169-2023. 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.