Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable… — Class II medical device recall Z-0685-2025

Ongoing recall by Spacelabs Healthcare, Ltd., reported 2024-12-25, distributed in AR, CA, CO, DE, FL, LA, MA, MI…. Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter rec

Recall number	`Z-0685-2025`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Spacelabs Healthcare, Ltd., Hertford, United Kingdom
Recall initiated	2024-11-25
Classified	2024-12-17
Reported by FDA	2024-12-25
Distributed	AR, CA, CO, DE, FL, LA, MA, MI, MN, MT, NC, NE, OH, OR, PA, PR, TN, TX, UT, VA, WA, WI
Countries outside the US	AE, AR, AT, AU, BE, BO, BR, CA, CH, CL, CN, CR, CZ, DE, DK, DO, EC, ES, FR, GB, GR, GT, HK, HN, HR, IE, IL, IN, IS, IT, KR, KW, LB, LT, MX, NL, OM, PA, PE, PL, PT, QA, RS, SA, SE, SG, SV, TR, TT, TW, VE, VN
Quantity	1,779 devices
Reason classes	labeling
UPC / GTIN / UDI-DI	`10841522128769`
Model numbers	`98900`

Product

Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.

Reason for recall

Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.

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-0685-2025. 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.