Best Practices kits containing certain production lots of Clearify… — Class II medical device recall Z-0890-2017
Terminated recall by Medtronic, reported 2016-12-28, distributed nationwide. Product sterility is compromised due to breach of the sterile barrier
| Recall number | Z-0890-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic, North Haven, CT, United States |
| Recall initiated | 2016-10-04 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2018-08-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BG, BR, CH, CL, CY, DE, DK, EG, ES, FI, FR, GB, GR, HU, IE, IL, IR, IT, JP, KE, KW, LU, LV, MX, NG, NL, NO, PL, PT, RO, RS, SA, SE, SK, TR, ZA |
| Quantity | 230 systems |
| Reason classes | sterility |
| Model numbers | 21-345 |
Product
Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Reason for recall
Product sterility is compromised due to breach of the sterile barrier
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-0890-2017. 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.