Reusable laparoscopic instruments are packaged as non-sterile — Class II medical device recall Z-2729-2014
Terminated recall by Instrumed International, Inc., reported 2014-10-08, distributed nationwide. Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoi
| Recall number | Z-2729-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumed International, Inc., Schaumburg, IL, United States |
| Recall initiated | 2014-05-30 |
| Classified | 2014-09-30 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2017-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 15 instruments |
| Lot numbers | 010113, 020113, 030112, 030413, 070412, 070512, 080211, 080212 |
| Model numbers | 250-08700, 250-08930, 250-089360, 250-08960, SD11451.140, SD175200.100, SD17520045.100 |
Product
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
Reason for recall
Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
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-2729-2014. 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.