Surgical Devices/Covidien Power Extender Straight, product code PES100; Power Extender Straight Reconditioned, product code PES100RC; Power Extender Curved with Integrated Controls Reconditioned, product code PEC200RC; Power Extender Straight with Integrated Controls Reconditioned, product code PES200RC. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Power Extender Straight, product code PES100; Power Extender Straight Reconditioned, product code PES100RC; Power Extender Curved with Integrated Controls Reconditioned, product code PEC200RC; Power Extender Straight with Integrated Controls Reconditioned, product code PES200RC.
Brand
Surgical Devices/Covidien
Lot Codes / Batch Numbers
all codes
Products Sold
all codes
Surgical Devices/Covidien is recalling Power Extender Straight, product code PES100; Power Extender Straight Reconditioned, product code PE due to Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.
Recommended Action
Per FDA guidance
The recalling firm issued an Urgent Medical Device Recall letter dated 9/22/09 to all customers. The letter informed customers that Covidien acquired PMI, about the problem with the products, and about the need to return any products remaining inventory. Customers were asked to return the entire inventory of Power Medical Interventions product, regardless of its expiration date. This process can be initiated by contacting Power Medical Innovations customer service at 1-866-769-3763.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026