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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Hazard
- Affected units
- 2,603
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.
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