FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EO The Expect Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
- Recall number
- Z-3215-2011
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EO The Expect Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
- Status
- Terminated
- Initiated
- 2011-08-11
- Posted
- 2011-09-16
- Terminated
- 2011-11-10
- Reason
- The firm has determined that a single lot of 25 ga Expect EUS/FNA devices were mislabeled. The carton label incorrectly described the devices as 22 ga. The inner pouch label incorrectly describes the device as 25 ga.
- Root cause
- Other
- Action
- Boston Scientific Corporation sent a "URGENT MEDICAL DEVICE RECALL letter dated August 11, 2010, to all affected customers. The letter identified the product, the problem and the action needed to be taken by customer. Customers were instructed to immediately remove the affected lot of Recall products from your inventory ( whether in Labs, Central Supply, Shipping and Receiving or any other location). Also, segregate this product in a secure location for return to Boston Scientific. Complete and return the Reply Verification Tracking Form ( even if you do not have any product to return) following the directions on this page and Reply Verification Tracking Form. Fax the Form to (508) 683-5578. Further questions please call (508) 683-4678.
- Quantity
- 30 units
- Distribution
- Nationwide Distribution including the states of VT, FL, SC, NC, WA, MA, and MN.
- Lot, serial or model codes
- Lot: 13615651C1; UPN M00550020
- 510(k) numbers
- ["K100712","K110030"]
- PMA numbers
- not on file
- Product code
- FCG
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- 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