United StatesAesculap is recalling four trocar sealing products—SEALING UNIT F/10/12MM TROCARS W.REDUCER (EK083P), SEALING CAP FOR 10/12MM TROCARS (EK085P), SEALING UNIT FOR 10/12MM TROCARS (EK086P), and REDUCING CONVERTER 10/12MM TO 5MM (EK087P)—with affected lot numbers and UDI-DIs listed in the notice. The recall was initiated because silicone fragments may detach from the yellow sealing component; these units were distributed worldwide, including U.S. locations in AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI, and in Canada.
What's being recalled
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
Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A
Recalling firm: Aesculap Inc, Center Valley, PA, United States.
How to identify it
Model No EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167 Model No EK085P; UDI-DI: 04046963620042; Lots 52987668, 52993442, 53001930, 53008562, 53013543, 52948710, 52954233, 52957528, 52966111, 52979586 Model No EK086P; UDI-DI: 04046963425272; Lots 52968398, 52975386, 52988022, 52993532, 53008999, 53009000, 53009001, 53009417 Model No EK087P; UDI-DI: 04046963620059; Lots 52974276, 52952133, 52954633, 52959357, 52964442, 52968887, 52972214, 52977427, 52981208, 52985519, 52988828, 52992514, 52993617, 52997919, 53002094, 53004347, 53006380, 53007625, 53010869, 53013557
The hazard
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was 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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)