Hillrom Welch Allyn HScribe Holter System — Class II medical device recall Z-0320-2025
Ongoing recall by Baxter Healthcare Corporation, reported 2024-11-13. There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system recei
| Recall number | Z-0320-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-10-11 |
| Classified | 2024-11-07 |
| Reported by FDA | 2024-11-13 |
| Quantity | 599 units |
| UPC / GTIN / UDI-DI | 00111080072938, 00111130075520, 00111190080489, 00111400096095, 00112320127784, 00116130382982, 00116400529499, 00117020550528, 00117460594755, 00117490599041, 00118090617166, 00118110621029, 00118120622023, 00118200638074, 00118220000011, 00118280001249, 00118280001256, 00118290000003, 00118310000693, 00118370000770, 00118390000385, 00118450001277, 00118450001284, 00119180001032, 00119300001270 and 48 more |
| Serial numbers | 10081765502216100, 110110037447, 110110037902, 110130040386, 110130040679, 110160042488, 110160042628, 110260052782, 110300055017, 110440063372, 110460064409, 110460064411, 110480065644, 110490065751, 110490065972, 110490065973, 110490066007, 110500066872, 110510067535, 111030070004, 111080072938, 111130075520, 111130075528, 111160078026, 111160078346 and 475 more |
Product
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
Reason for recall
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
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-0320-2025. 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.