Valleylab Laparoscopic Straight Spatula Electrode 28CM Item Code:… — Class II medical device recall Z-2568-2016
Terminated recall by Medtronic, reported 2016-08-24, distributed nationwide. Potential for compromise of the package resulting in a breach of the sterile barrier
| Recall number | Z-2568-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic, North Haven, CT, United States |
| Recall initiated | 2016-07-08 |
| Classified | 2016-08-17 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2018-08-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, HK, JP, KR, TH |
| Quantity | 6,720 |
| Reason classes | sterility |
| Model numbers | E278028 |
Product
Valleylab Laparoscopic Straight Spatula Electrode 28CM Item Code: E278028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Reason for recall
Potential for compromise of the package resulting in a 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-2568-2016. 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.