FDA Medical Device Recalls (openFDA)
Anchor Products Company, Inc.: Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 10 mm, 225 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS100SB The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery.
- Recall number
- Z-1590-2011
- Recalling firm
- Anchor Products Company, Inc.
- Product
- Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 10 mm, 225 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS100SB The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery.
- Status
- Terminated
- Initiated
- 2010-12-09
- Posted
- 2011-03-07
- Terminated
- 2012-01-20
- Reason
- The metal component within the unit can break and cause a malfunction. Use of the device may represent a potential health hazard if the metal component is not removed after breakage.
- Root cause
- Device Design
- Action
- The firm, Anchor, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 8, 2010 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any remaining units to their distributor for replacement; and complete and return the attached ANCHOR RECALL RETURN RESPONSE FORM via fax to (314) 961-4535 or mail to: Progressive Medical, Inc., Attn: Marketing Manager, 11085 Gravois Industrial Court, St. Louis, MO 63128, even if they have no inventory. A representative of Anchor Products then visited each of the direct accounts to help them implement their subrecall of the devices from their customers. For additional information please contact: Vice President, Anchor Products Company at 1-800-543-9124 or 1-630-543-9124; and the distributor at 1-800-969-6331 or 1-314-961-4535.
- Quantity
- 88,785 units
- Distribution
- Worldwide distribution: USA including state of: Missouri; and countries including: Australia, Belgium, Canada, France, Greece, Ireland, Japan, Spain and the United Kingdom.
- Lot, serial or model codes
- Code TRS100SB, lots P05N, P07N, P11N, P13N, P19N, P20N, P23N, P25N, P29N, P30N, P31N, P34N, P37N, P41N, P42N, P43N, P44N, P46N, P47N, P48N, P49N, P51N, P52N, P53N, P55N, P56N, P57N, P58N, P60N, P61N, P66N, P68N, P69N, P71N, P75N, P78N, P85N, P90N, P94N, P94N, P96N, P98N, P99N, Q02N, Q04N, Q05N, Q06N, Q09N, Q11N, Q12N, Q13N, Q14N, Q17N, Q20N, Q23N, Q24N, Q30N, Q31N, Q36N, Q38N, Q41N, Q49N, Q50N and Q65N
- 510(k) numbers
- ["K061555"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 1416891
- Firm city
- Addison
- Firm state
- IL
- 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