Medline Probe Cover Kits containing Turkuaz Ultrasound Gel — Class II medical device recall Z-2290-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-08-09, distributed nationwide. Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
| Recall number | Z-2290-2023 |
|---|---|
| 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 | 2023-05-15 |
| Classified | 2023-08-03 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CN, CR, IN, LB, PA, QA, SA, SG |
| Quantity | 1,231,480 kits |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 10884389114094, 10884389114100, 10884389114117, 10884389114124, 10888277723641, 20888277723648, 40884389114095, 40884389114101, 40884389114118, 40884389114125 |
| Lot numbers | 06920030012, 06920030021, 06920040022, 06920050011, 06920050012, 06920060012, 06920070011, 06920070021, 06920080012, 06920090011, 06920100011, 06920110011, 06920110012, 06920120011, 06920120012, 06921010011, 06921010022, 06921020011, 06921020021, 06921030011, 06921030012, 06921030021, 06921030031, 06921040011, 06921050011, 06921060011, 06921070011, 06921080011, 06921090011, 06921090012, 06921100011, 06921100012, 06921100013, 06921110011, 06921120011, 0692112H022, 0692201H011, 0692202H011, 0692202H024, 0692203H011 and 6 more |
| Model numbers | DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900 |
Product
Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Number DYNJE5920; d. COVER, PROBE, W/GEL AND BANDS, 6X96 - Model Number DYNJE5930; e. COVER, PROBE, W/GEL AND BANDS, 5X48 - Model Number DYNJE5940; f. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJEX5900
Reason for recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
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-2290-2023. 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.