The Recall Desk
HighFDA (Devices)·Z-0159-2013·Announced 2012-11-07

Progressive Medical Recalls Endoscopic Dissector Due to Tip Unraveling Risk

Progressive Medical Inc is recalling 124 boxes of PMI Endoscopic Dissectors because the tip could come loose or unravel during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that could cause harm during a procedure, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Progressive Medical Inc is recalling 124 boxes of PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number PMILK40. The product is sterile, cotton-tipped, and X-ray detectable, intended for use in gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.

The recall was initiated because the tip of the product could come loose or unravel. This defect poses a risk during medical procedures where the device is used to push tissue from an incision or wound.

The affected units were distributed nationwide in Colorado, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Tennessee, Texas, Virginia, and Wisconsin. Healthcare facilities and consumers should stop using the product and contact Progressive Medical Inc for further instructions.

The recalled product

Product
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue
Affected units
124

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 1104-01

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically: