CLASS II ONGOING Device recall · Reported 11 Jan 2023 · FDA Enforcement Report
Disposable Trocars with Blunt Pushers for Use recalled
ENDO Pharmaceuticals Solutions is recalling Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants, distributed nationwide in the US. The recall was initiated on 8 Nov 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0774-2023
- FDA event ID
- 91236
- Recalling firm
- ENDO Pharmaceuticals Solutions, Cranbury, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Nov 2022
- FDA classified
- 30 Dec 2022
- Reported
- 11 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 8 Nov 2022 | Recall initiated by company | |
| 30 Dec 2022 | Classified by FDA | +52 days |
| 11 Jan 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
No expiration dates printed on the packaging
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
Where it was distributed
Nationwide
Questions about this recall
Is Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants recalled?
Yes. ENDO Pharmaceuticals Solutions recalled Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants on 8 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0774-2023.
Why was it recalled?
No expiration dates printed on the packaging
Which lots are affected?
UDI: N/A Lot Numbers: 58672, 58673
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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