Aesculap, Inc.

FDA Regulatory Profile

Summary

Total Recalls
42
510(k) Clearances
218
Inspections
20
Compliance Actions
1

Known Names

aesculap, aesculap implant systems

Recent Recalls

NumberClassProductDate
Z-1485-2026Class IIBrand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FJanuary 15, 2026
Z-0311-2026Class IIBrand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P September 24, 2025
Z-0310-2026Class IIBrand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P SSeptember 24, 2025
Z-0312-2026Class IIBrand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P September 24, 2025
Z-0309-2026Class IIBrand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: September 24, 2025
Z-0027-2026Class IIAESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.August 18, 2025
Z-0026-2026Class IIAESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.August 18, 2025
Z-1310-2025Class IINumerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MJanuary 31, 2025
Z-1312-2025Class IINumerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 19January 31, 2025
Z-1308-2025Class IINumerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STJanuary 31, 2025
Z-1309-2025Class IINumerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) January 31, 2025
Z-1311-2025Class IINumerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2January 31, 2025
Z-2139-2024Class IIAeos Robotic Digital Microscope, Product Code: PV010May 13, 2024
Z-1244-2024Class IIDISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.January 9, 2024
Z-1247-2024Class IIDISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.January 9, 2024
Z-1246-2024Class IIDISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.January 9, 2024
Z-1245-2024Class IIDISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.January 9, 2024
Z-1243-2024Class IIDISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.January 9, 2024
Z-0866-2024Class IIMB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD December 29, 2023
Z-0867-2024Class IIMB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLDecember 29, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K242762Aesculap Aicon® Series Container SystemMay 13, 2025
K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetDecember 16, 2024
K223596SQ.line KERRISONJune 29, 2023
K214041Aesculap AICON ContainerDecember 30, 2022
K211572Aesculap Slim Clip ApplierDecember 13, 2021
K203739ELAN 4 Electro Motor SystemAugust 24, 2021
K202391DIR 800January 21, 2021
K203461Aesculap Caiman 12 Seal and Cut Technology SystemDecember 18, 2020
K202938Aesculap Caiman 5 Seal and Cut Technology SystemOctober 30, 2020
K202124Aesculap PAS-Port Proximal Anastomosis SystemSeptember 2, 2020
K200950Ventricular CatheterMay 8, 2020
K192056JJ Series Container SystemMarch 27, 2020
K193582SterilContainer S2 SystemMarch 17, 2020
K192266M. Blue Adjustable Shunt SystemNovember 21, 2019
K183203ELAN 4 ToolsAugust 9, 2019
K182414Aesculap® SterilContainer(TM) S2 SystemJuly 5, 2019
K190174Miethke Shunt System GAV 2.0 and SA 2.0 ValvesJuly 5, 2019
K183180Caiman 5 MarylandMarch 12, 2019
K182527ELAN 4 ToolsJanuary 19, 2019
K182032SterilContainer S SystemDecember 21, 2018