Z-0774-2023Class II

9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01

Name: Z-0774-2023 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
Creator: ENDO Pharmaceuticals Solutions, Inc.
Published: 2022-11-08
License: https://open.fda.gov/license/

Endo USA / initiated 2022-11-08 / Open, Classified / root cause: packaging

FDA source

ENDO Pharmaceuticals Solutions, Inc. began a recall of 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01 on 2022-11-08. FDA classified it as Class II and gives the reason as "No expiration dates printed on the packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0774-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-08
Posted: 2022-12-30
Recalling firm: Endo USA
Product: 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: No expiration dates printed on the packaging
Root cause tag: packaging
FDA 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 [email protected] 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 in commerce: 2603 units
Distribution: Nationwide
Product codes and lots: UDI: N/A Lot Numbers: 58672, 58673

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0774-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0774-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-11	2022-12-30

Product code MDM

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)