CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report
Sealing Unit F/ Trocars W.reducer recalled by Aesculap
Aesculap is recalling Sealing Unit F/ Trocars W.reducer, distributed nationwide in the US. The recall was initiated on 24 Sep 2025 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-0309-2026
- FDA event ID
- 97649
- Recalling firm
- Aesculap, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Sep 2025
- FDA classified
- 24 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 24 Sep 2025 | Recall initiated by company | |
| 24 Oct 2025 | Classified by FDA | +30 days |
| 5 Nov 2025 | 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
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
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
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A
Where it was distributed
Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.
Nationwide ArkansasArizonaCaliforniaConnecticutMarylandNebraskaNew MexicoNew YorkOregonPennsylvaniaWashingtonWisconsin
Questions about this recall
Why was it recalled?
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Which lots are affected?
Model No EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167
Where was it sold?
Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and 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
3 other products · FDA event 97649| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Reducing Converter recalled by Aesculap | Aesculap | Packaging Defects | Nationwide | |
| CLASS II | Sealing Cap For Trocars recalled by Aesculap | Aesculap | Packaging Defects | Nationwide | |
| CLASS II | Sealing Unit For Trocars recalled by Aesculap | Aesculap | Packaging Defects | 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 | Elan 4 Fixed Duraguard Long recalled by Aesculap AG | Aesculap | Labeling Errors | MO |
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 |