Aesculap Inc
Aesculap Inc appears in FDA public data with 42 recalls, 218 510(k) clearances, 20 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1485-2026, Class II) was initiated on January 15, 2026. Its most recent 510(k) clearance was granted on May 13, 2025.
Summary
- Total Recalls
- 42
- 510(k) Clearances
- 218
- Inspections
- 20
- Compliance Actions
- 1
Known Names
aesculap, aesculap implant systems
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1485-2026 | Class II | Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: F | January 15, 2026 |
| Z-0311-2026 | Class II | Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P | September 24, 2025 |
| Z-0312-2026 | Class II | Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P | September 24, 2025 |
| Z-0310-2026 | Class II | Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P S | September 24, 2025 |
| Z-0309-2026 | Class II | Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: | September 24, 2025 |
| Z-0027-2026 | Class II | AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R. | August 18, 2025 |
| Z-0026-2026 | Class II | AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. | August 18, 2025 |
| Z-1309-2025 | Class II | Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) | January 31, 2025 |
| Z-1312-2025 | Class II | Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 19 | January 31, 2025 |
| Z-1310-2025 | Class II | Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190M | January 31, 2025 |
| Z-1308-2025 | Class II | Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps ST | January 31, 2025 |
| Z-1311-2025 | Class II | Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2 | January 31, 2025 |
| Z-2139-2024 | Class II | Aeos Robotic Digital Microscope, Product Code: PV010 | May 13, 2024 |
| Z-1245-2024 | Class II | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures. | January 9, 2024 |
| Z-1247-2024 | Class II | DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures. | January 9, 2024 |
| Z-1244-2024 | Class II | DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures. | January 9, 2024 |
| Z-1246-2024 | Class II | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures. | January 9, 2024 |
| Z-1243-2024 | Class II | DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures. | January 9, 2024 |
| Z-0866-2024 | Class II | MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD | December 29, 2023 |
| Z-0867-2024 | Class II | MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDL | December 29, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K242762 | Aesculap Aicon® Series Container System | May 13, 2025 |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | December 16, 2024 |
| K223596 | SQ.line KERRISON | June 29, 2023 |
| K214041 | Aesculap AICON Container | December 30, 2022 |
| K211572 | Aesculap Slim Clip Applier | December 13, 2021 |
| K203739 | ELAN 4 Electro Motor System | August 24, 2021 |
| K202391 | DIR 800 | January 21, 2021 |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology System | December 18, 2020 |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology System | October 30, 2020 |
| K202124 | Aesculap PAS-Port Proximal Anastomosis System | September 2, 2020 |
| K200950 | Ventricular Catheter | May 8, 2020 |
| K192056 | JJ Series Container System | March 27, 2020 |
| K193582 | SterilContainer S2 System | March 17, 2020 |
| K192266 | M. Blue Adjustable Shunt System | November 21, 2019 |
| K183203 | ELAN 4 Tools | August 9, 2019 |
| K182414 | Aesculap® SterilContainer(TM) S2 System | July 5, 2019 |
| K190174 | Miethke Shunt System GAV 2.0 and SA 2.0 Valves | July 5, 2019 |
| K183180 | Caiman 5 Maryland | March 12, 2019 |
| K182527 | ELAN 4 Tools | January 19, 2019 |
| K182032 | SterilContainer S System | December 21, 2018 |