FDA Medical Device Recalls (openFDA)
Micro-Tech (Nanjing) Co., Ltd.: Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box level) - BF40183(Over shipper level), STERILE
- Recall number
- Z-0237-2019
- Recalling firm
- Micro-Tech (Nanjing) Co., Ltd.
- Product
- Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box level) - BF40183(Over shipper level), STERILE
- Status
- Terminated
- Initiated
- 2018-09-20
- Posted
- not on file
- Terminated
- 2019-10-21
- Reason
- Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units
- Root cause
- Under Investigation by firm
- Action
- On September 20, 2018 Micro-Tech (Nanjing) Co., Ltd emailed their US distributor advising them of a recall. On September 20,2018, Micro-Tech Endoscopy issued URGENT MEDICAL DEVICE RECALL notices to all U.S. customers. On October 15, 2018, Micro-Tech Endoscopy issued AMENDED URGENT MEDICAL DEVICE RECALL notices to all U.S. customers. The following are Actions To Be Taken By Customers: - Inspect stock and quarantine products subject to recall - Customers with products quarantined & subject to recall should Return the completed Recall Return Response Acknowledgement and Receipt Form via Fed Ex account provided - Do not return USED devices - Customers who DO NOT have devices subject to call are advised to return the completed Recall Return Response Acknowledgement and Receipt Form via email to Quality@mtendoscopy.com Customers with questions may contact Angela Smith 1-877-552-4027
- Quantity
- 1360 pcs
- Distribution
- US Nationwide Distribution in the states of AL, CA, IN, FL, GA, MO, MT, NV, OK, OR, PA TX & Washington D.C.
- Lot, serial or model codes
- Lot Number - M180409031 Date of Manufacture - 20180409 Use By - 20220408
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEN
- Firm FEI
- 3004837686
- Firm city
- Nanjing National Nanjing
- Firm state
- not on file
- Firm country
- China
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