Endopath Electrosurgery Probe Plus II — Class II medical device recall Z-1772-2013
Terminated recall by Ethicon Endo-Surgery Inc, reported 2013-07-31, distributed nationwide. The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packa
| Recall number | Z-1772-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Cincinnati, OH, United States |
| Recall initiated | 2013-04-08 |
| Classified | 2013-07-19 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2013-12-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CL, CN, CZ, DO, EC, EG, ES, GB, ID, IL, IN, IT, JM, JP, KR, KW, MX, MY, PA, PH, PK, PL, RU, SA, SG, SI, TH, TR, TW, UY, VE, ZA |
| Quantity | 327,648 instruments |
| Reason classes | sterility |
Product
Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.
Reason for recall
The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device.
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-1772-2013. 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.