FDA Medical Device Recalls (openFDA)
Boss Instruments, Ltd.: BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris.
- Recall number
- Z-2767-2020
- Recalling firm
- Boss Instruments, Ltd.
- Product
- BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris.
- Status
- Terminated
- Initiated
- 2020-06-26
- Posted
- not on file
- Terminated
- 2021-07-20
- Reason
- The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
- Root cause
- Nonconforming Material/Component
- Action
- Urgent Voluntary Medical Device Recall notification letters dated 6/26/20 were emailed to customers. Please distribute this information to any of your customers who may have these units in their possession and ask that they return them to Boss Instruments Ltd. for full credit by no later than August 3l5t, 2020. We also ask that any remaining units of this lot held in your current inventory be returned to us immediately for full credit. Please contact me directly at the email address listed below, call our toll free number: 1-540-832-5000 or contact your normal customer account manager so that we can assign you a returned goods authorization number (RGA#) and further assist you in return of the product noted above. Please note that replacements will be provided on a first come first serve bases and we are working with our supplier to make all replacement units available as soon as possible. We recognize that the withdrawal of these DeBakey needle holders may be disruptive to your facility and we apologize for any inconvenience this may cause. If you have any addition questions regarding this action or to report any customer complaints, please contact me at jamesgano@bossinst.com.
- Quantity
- 96 devices
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, TN, TX and the countries of England, Japan, New Zealand, South Africa, South Korea, Taiwan.
- Lot, serial or model codes
- Lot Numbers: 00351415,00425391, 00374008,07702195, 08801812, 08802271, 00383211,00384765,00418258, 08804204,09900093, 09900383
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FHQ
- Firm FEI
- 1000140363
- Firm city
- Zion Crossroads
- Firm state
- VA
- 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