Surgicutt fully automated incision making device for bleeding time… — Class II medical device recall Z-0137-2014
Terminated recall by ITC-Nexus Dx, reported 2013-11-13, distributed nationwide. ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) d
| Recall number | Z-0137-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ITC-Nexus Dx, Edison, NJ, United States |
| Recall initiated | 2013-08-22 |
| Classified | 2013-11-04 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-06-09 |
| Distributed | Nationwide (US) |
| Lot numbers | AK301M |
| Expiration dates | 2017-08-31 |
Product
Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.
Reason for recall
ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
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-0137-2014. 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.