Aesculap Inc recalls Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product…
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Read the official notice →- Date
- 2025-11-05
- Country
- United States
- Brand
- Aesculap
- Product
- Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Aesculap recalls
- 2026-03-11
USAesculap Inc recalls Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product…
There is the potential for the length of the trocar shaft to be too long.
FDA · DeviceAesculap IncUS Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA, HI, IA,…Official notice →- 2025-10-08
- US
Aesculap AG recalls AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
FDA · DeviceAesculap AGUS distribution to Missouri. OUS International distribution to Norway,…Official notice → - 2025-03-19
- US
Aesculap Inc recalls Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps…
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
FDA · DeviceAesculap IncDistribution was made nationwide and to PR. There was also government/military…Official notice → - 2024-06-19
- US
Aesculap Inc recalls Aeos Robotic Digital Microscope, Product Code: PV010
Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.
FDA · DeviceAesculap IncUS Nationwide distribution in the states of AR, FL, IL, IN, KY, MI, NC, NE,…Official notice → - 2024-03-13
- US
Aesculap Inc recalls DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
The sterile blister packaging may be damaged, and sterility may be compromised.
FDA · DeviceAesculap IncWorldwide - US Nationwide distribution in the states of KS, NJ and NY. The…Official notice → - 2024-02-07
- US
Aesculap Inc recalls MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
FDA · DeviceAesculap IncUS Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT,…Official notice →
Other drugs & medical recalls in the United States
- 2025-11-05
- US
Surgical Theater Inc recalls SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
FDA · DeviceSurgical Theater IncWorldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA,…Official notice → - US
Dexcom, Inc. recalls Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number:…
A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could…
FDA · DeviceDexcom, Inc.This product was distributed throughout the US. G6 Android US v1.15.0 SW11678…Official notice → - US
ENDOMAGNETICS LTD recalls Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a…
Potential for contamination with cotton fibers.
FDA · DeviceENDOMAGNETICS LTDWorldwide - US Nationwide distribution in the states of CA, CO, CT, DC, FL,…Official notice → - US
Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number:…
Due to incomplete seals in the pouch which provide the sterile barrier.
FDA · DeviceAlcon Research LLCWorldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice → - US
BALT USA, LLC recalls Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100,…
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
FDA · DeviceBALT USA, LLCUS distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and…Official notice → - US
IMPRIS Imaging Inc recalls IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet…
FDA · DeviceIMPRIS Imaging IncWorldwide distribution - US Nationwide and the countries of Canada, Sweden,…Official notice →