Z-2767-2020Class II

BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 -

Name: Z-2767-2020 BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 -
Creator: Boss Instruments, Ltd.
Published: 2020-06-26
License: https://open.fda.gov/license/

Boss Instruments, Ltd. / initiated 2020-06-26 / Terminated / root cause: manufacturing process

FDA source

Boss Instruments, Ltd. began a recall of 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... on 2020-06-26. FDA classified it as Class II and gives the reason as "The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2767-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-26
Posted: 2020-08-05
Terminated: 2021-07-20
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.
Product code: FHQ Holder, Needle, Gastroenterologic
Reason for recall: The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
Root cause tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: Lot Numbers: 00351415,00425391, 00374008,07702195, 08801812, 08802271, 00383211,00384765,00418258, 08804204,09900093, 09900383

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2767-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2767-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-05

Product code FHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)