Signature Laparoscopic Instruments — Class II medical device recall Z-1900-2025
Ongoing recall by Silex Medical, LLC, reported 2025-06-11, distributed nationwide. Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exp
| Recall number | Z-1900-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Silex Medical, LLC, Southington, CT, United States |
| Recall initiated | 2024-01-09 |
| Classified | 2025-06-02 |
| Reported by FDA | 2025-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| Lot numbers | M28188 |
| Serial numbers | 0107, 0108 |
| Model numbers | 5881033 |
Product
Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033.
Reason for recall
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
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-1900-2025. 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.