Siemens Healthcare Caps for capillary 50/60 uL — Class II medical device recall Z-1258-2015
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2015-03-18, distributed nationwide. Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in
| Recall number | Z-1258-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Inc, Norwood, MA, United States |
| Recall initiated | 2015-01-22 |
| Classified | 2015-03-06 |
| Reported by FDA | 2015-03-18 |
| Terminated | 2016-04-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CO, CW, CZ, DE, EE, ES, FI, FR, GB, HK, HR, IE, IT, JO, JP, LT, LV, MX, NL, NO, NZ, PL, PT, RS, SA, SE, SG, SK, TH, TW, ZA |
| Quantity | 6,184 |
| Reason classes | foreign material, device malfunction |
| Model numbers | 478527 |
Product
Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10328655 Legacy Part number: 478527
Reason for recall
Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary
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-1258-2015. 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.