FDA Medical Device Recalls (openFDA)
Progressive Medical Inc: 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. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
- Recall number
- Z-0276-2013
- Recalling firm
- Progressive Medical Inc
- 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. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
- Status
- Terminated
- Initiated
- 2011-12-09
- Posted
- 2012-11-09
- Terminated
- 2012-11-14
- Reason
- Some of the sterile packages had broken seals.
- Root cause
- Packaging
- Action
- Progressive Medical Inc contacted their customers via telephone on December 9, 2011, through December 15, 2011. Customers were informed the reason for recall was explained and the customer was asked if any of the lot remained in their inventory. If inventory remained, the recalling firm sent them a return goods authorization number and informed them the product would be replaced. For further questions please call (314) 961-5786.
- Quantity
- 70 boxes
- Distribution
- USA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI.
- Lot, serial or model codes
- Lot 1108-01
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDI
- Firm FEI
- 3000236238
- Firm city
- Saint Louis
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28