Teleflex Percuaneous Solutions — Class II medical device recall Z-0058-2017
Terminated recall by Teleflex Medical, reported 2016-10-19, distributed in AZ, CA, FL, NC, NY, TX. The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers and
| Recall number | Z-0058-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2016-09-09 |
| Classified | 2016-10-07 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2017-08-25 |
| Distributed | AZ, CA, FL, NC, NY, TX |
| Quantity | 160 units |
| Reason classes | labeling |
| Lot numbers | 73M1500175 |
| Model numbers | ML003EE |
Product
Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue during laparoscopic surgery.
Reason for recall
The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers.
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-0058-2017. 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.