FDA Medical Device Recalls (openFDA)
ENDO Pharmaceuticals Solutions, Inc.: 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
- Recall number
- Z-0774-2023
- Recalling firm
- ENDO Pharmaceuticals Solutions, Inc.
- Product
- 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
- Status
- Open, Classified
- Initiated
- 2022-11-08
- Posted
- 2022-12-30
- Terminated
- not on file
- Reason
- No expiration dates printed on the packaging
- Root cause
- Incorrect or no expiration date
- Action
- Endo Pharmaceuticals issued Medical Device Market Withdrawal letter dated 12/8/22 to Distributor and End-Users via email/mail. Letter states reason for recall, health risk and action to take: 1. If you have any affected lots in your inventory, please immediately quarantine to prevent any further use. 2. Please complete the Market Withdrawal Acknowledgement and Receipt Form (attached below)and email to marketwithdrawal@endo.com or return by fax to 1-610-561-3085. 3. A shipping label will be mailed to the address provided on the Market Withdrawal Acknowledgement and Receipt form and any affected devices along with the completed form are returned to: Endo Pharmaceuticals 8 Clarke Dr., Suite 6 Cranbury, NJ 08512 Attn: Trocar Market Withdrawal Returned product will be replaced by Endo Pharmaceuticals Inc. Customers who have questions or need additional information regarding this correction may contact Endo at 1-800-462-3636. If you have further distributed this product, please identify and notify your customers of this product recall. Please ensure that this notification is forwarded to all Healthcare Professionals who have received the 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants from the lots identified in Table 1 (page 3 of 5). Please let end users know to return for replacement . November 8, 2022 Endo notified the wholesaler to prevent any further distribution of the affected lots.
- Quantity
- 2603 units
- Distribution
- Nationwide
- Lot, serial or model codes
- UDI: N/A Lot Numbers: 58672, 58673
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDM
- Firm FEI
- 2243842
- Firm city
- Cranbury
- Firm state
- NJ
- 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