CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report
Disp.Trocar W.Dilating Pin, Product recalled by Aesculap
Aesculap is recalling Disp.trocar W.dilating Pin, distributed nationwide in the US. The recall was initiated on 9 Jan 2024 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-1246-2024
- FDA event ID
- 93856
- Recalling firm
- Aesculap, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jan 2024
- FDA classified
- 1 Mar 2024
- Reported
- 13 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 9 Jan 2024 | Recall initiated by company | |
| 1 Mar 2024 | Classified by FDA | +52 days |
| 13 Mar 2024 | 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
The sterile blister packaging may be damaged, and sterility may be compromised.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
Where it was distributed
Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
Questions about this recall
Why was it recalled?
The sterile blister packaging may be damaged, and sterility may be compromised.
Which lots are affected?
Product Code: EK236SU; UDI/DI: 04046963620479; Batch Numbers (Expiration Date): 52580815 (12/08/2023);
Where was it sold?
Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 93856This product is part of a recall event; the main page for the event is Disp.Hasson Trocar, Product recalled by Aesculap.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Disp.Hasson Trocar, Product recalled by Aesculap | Aesculap | Sterility | Nationwide | |
| CLASS II | Disp.Trocar W.Dilating Pin, Product recalled by Aesculap | Aesculap | Sterility | Nationwide | |
| CLASS II | Disp.trocar W recalled by Aesculap | Aesculap | Sterility | Nationwide | |
| CLASS II | Disp.Hasson Trocar, Product recalled by Aesculap | Aesculap | Sterility | Nationwide |
More recalls from Aesculap
All 42| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Minop Trocar 4 Wking Channel6 recalled by Aesculap | Aesculap | Device Malfunction | Nationwide |
| Device | CLASS II | Sealing Unit For Trocars recalled by Aesculap | Aesculap | Packaging Defects | Nationwide |
| Device | CLASS II | Sealing Cap For Trocars recalled by Aesculap | Aesculap | Packaging Defects | Nationwide |
| Device | CLASS II | Reducing Converter recalled by Aesculap | Aesculap | Packaging Defects | Nationwide |
| Device | CLASS II | Sealing Unit F/ Trocars W.reducer recalled by Aesculap | Aesculap | Packaging Defects | Nationwide |
Other Surgical Instruments recalls
All 3,891| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |