The Recall Desk
HighFDA (Devices)·Z-0774-2023·Announced 2023-01-11

Disposable Trocars Lack Printed Expiration Dates on Packaging

ENDO Pharmaceuticals is recalling 2,603 disposable trocars because packaging does not include printed expiration dates, creating risk of use of expired sterile devices.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall where a required label element—expiration date—is missing from the packaging. Although no illnesses or injuries have been reported, the missing expiration date creates risk of harm through potential use of compromised or expired sterile devices.

Plain-English summary

ENDO Pharmaceuticals Solutions, Inc. is recalling 9 Gauge Disposable Trocars with Blunt Pushers (Part Number 50134-01). A total of 2,603 units have been recalled and were distributed nationwide.

The recalled devices lack printed expiration dates on the packaging. Affected lot numbers are 58672 and 58673. The devices are intended for use with subcutaneous implants.

Consumers who have received these devices should discontinue use immediately. Healthcare facilities and providers should contact ENDO Pharmaceuticals for device replacement, return instructions, or additional information about this recall.

The recalled product

Product
9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
Manufacturer
ENDO Pharmaceuticals Solutions, Inc.
Category
Medical Device — Surgical Instrument
Hazard
  • missing-expiration-date

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI: N/A Lot Numbers: 58672
  • 58673

Distribution

Distributed nationwide across the United States.

Related recalls

Same category