Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended… — Class II medical device recall Z-1892-2018
Terminated recall by Southmedic, Inc., reported 2018-05-23, distributed in IA, IL, NE, NY, TX. Scalpels lot contains non-sterile products labeled as sterile.
| Recall number | Z-1892-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Southmedic, Inc., Barrie, Canada |
| Recall initiated | 2017-11-06 |
| Classified | 2018-05-17 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2020-04-02 |
| Distributed | IA, IL, NE, NY, TX |
| Quantity | 3,300 scalpels |
| Reason classes | labeling, sterility |
| Lot numbers | 092517 |
| Model numbers | 73-0115 |
Product
Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
Reason for recall
Scalpels lot contains non-sterile products labeled as sterile.
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-1892-2018. 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.