FDA Medical Device Recalls (openFDA)
Olympus America Inc.: Olympus OFP Flushing Pump irrigation tubing The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as part of an Olympus endoscopic imaging system to facilitate washing of gastric and colonic mucosa to remove blood, feces and other organic matter, enabling improved visualization, diagnosis and therapy during endoscopic procedures.
- Recall number
- Z-0806-2012
- Recalling firm
- Olympus America Inc.
- Product
- Olympus OFP Flushing Pump irrigation tubing The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as part of an Olympus endoscopic imaging system to facilitate washing of gastric and colonic mucosa to remove blood, feces and other organic matter, enabling improved visualization, diagnosis and therapy during endoscopic procedures.
- Status
- Terminated
- Initiated
- 2011-12-12
- Posted
- 2012-01-18
- Terminated
- 2012-09-25
- Reason
- Water may leak from the irrigation tubing used on the Olympus Flushing Pump
- Root cause
- Nonconforming Material/Component
- Action
- The firm,Olympus, sent an "URGENT-DEVICE CORRECTION " letter dated December 12, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were informed that any current irrigation tubing in their inventory can be used with the OFP pump; however, they must inspect the tubing installed on the OFP pump for signs of water leakage; if leakage is found, discontinue use of the tubing and replace with a new irrigation tube. In addition, complete and return the enclosed questionnaire via fax to (484) 896-7128. If you do not wish to use your current inventory of irrigation tubing and would like a replacement, call Olympus Customer Care Center at 1-800-848-9024. Olympus is discontinuing the current version of irrigation tubing and has redesigned the irrigation tubing to prevent water leakage. For any additional information, contact the V.P., Regulatory/Clinical Affairs & Quality Assurance at (484) 896-5688 or email at laura.storms-tyler@olympus.com.
- Quantity
- 64,667 packages of 10 irrigation tubes
- Distribution
- Nationwide distribution: USA including states of: AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, AND WY.
- Lot, serial or model codes
- Catalog number 7501669
- 510(k) numbers
- ["K000948"]
- PMA numbers
- not on file
- Product code
- FEQ
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- 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
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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