Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 30, 2025
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and
1152-00
Reason: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Root cause: Under Investigation by firm
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.Recall #Z-0369-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 30, 2025
BD Pyxis Pro MedStation Main, REF: 1155-00
Reason: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Root cause: Under Investigation by firm
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.Recall #Z-0370-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 30, 2025
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
Reason: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Root cause: Under Investigation by firm
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.Recall #Z-0371-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated May 5, 2025
SAFE-T-FILL Micro Capillary Blood Collection, 125 L Prepared with Dipotassium EDTA Purple, Model: 07 6011;
SAFE-T-FILL Micro Capillary Blood Collection, 125 L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013;
SAFE-T-FILL Micro Capillary Blood Collection, 200 L Prepared with Dipotassium EDTA Purple, Model: 07 7051;
SAFE-T-FILL Micro Capillary Blood Collection, 150 L Prepared with Dipotassium EDTA Purple, Model: 07 7052;
SAFE-T-FILL Micro Capillary Blood Collection, 300 L Prepared with Dipotassium EDTA Purple, Model: 07 7053;
SAFE-T-FILL Micro Capillary Blood Collection, 200 L Prepared with Dipotassium EDTA Purple, Model: 07 7056;
SAFE-T-FILL Micro Capillary Blood Collection, 200 L Prepared with Dipotassium EDTA Flat Bottom Microtube, Purple, Model: 07 7058
SAFE-T-FILL End-to-End Capillary Tubes, 30 L; Plastic, Prepared with EDTA Dipotassium
Model: 06 0910
Reason: All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Root cause: Component design/selection
Recalling firm: ASP Global, LLC. dba Anatomy Supply Partners, LLC.Type: Tubes, Vials, Systems, Serum Separators, Blood CollectionDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI and the country of CA.Recall #Z-0372-2026
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 25, 2025
Model: Incisive CT;
Product Code (REF): (1) 728143, (2) 728144;
Software Versions: 5.1.0.X & 5.1.1.X;
Reason: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop.
Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the
WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient
dose setting after the surview. If operator misses the insufficient dose and the WED value in User
Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting.
Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient.
Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images.
Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient.
Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan.
There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.
Root cause: Under Investigation by firm
Recalling firm: PHILIPS MEDICAL SYSTEMSType: System, X-Ray, Tomography, ComputedDistribution: Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA;
International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland, France, Germany, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Libya, Netherlands, Nicaragua, Norway, Panama, Philippines, Poland, Portugal, Reunion, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, U.A.E., Yemen;
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 25, 2025
Model: CT 5300;
Product Code (REF): 728285;
Software Versions: 5.1.0.X & 5.1.1.X;
Reason: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop.
Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the
WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient
dose setting after the surview. If operator misses the insufficient dose and the WED value in User
Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting.
Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient.
Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images.
Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient.
Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan.
There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.
Root cause: Under Investigation by firm
Recalling firm: PHILIPS MEDICAL SYSTEMSType: System, X-Ray, Tomography, ComputedDistribution: Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA;
International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland, France, Germany, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Libya, Netherlands, Nicaragua, Norway, Panama, Philippines, Poland, Portugal, Reunion, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, U.A.E., Yemen;
Open, ClassifiedPosted Oct 27, 2025·Initiated Sep 25, 2025
Model: Incisive CT for Brazil SKD;
Product Code (REF): 728146;
Software Versions: 5.1.0.X & 5.1.1.X;
Reason: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop.
Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the
WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient
dose setting after the surview. If operator misses the insufficient dose and the WED value in User
Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting.
Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient.
Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images.
Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient.
Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan.
There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.
Root cause: Under Investigation by firm
Recalling firm: PHILIPS MEDICAL SYSTEMSType: System, X-Ray, Tomography, ComputedDistribution: Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA;
International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland, France, Germany, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Libya, Netherlands, Nicaragua, Norway, Panama, Philippines, Poland, Portugal, Reunion, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, U.A.E., Yemen;
Open, ClassifiedPosted Oct 24, 2025·Initiated Sep 25, 2025
Brand Name: MEGA Ballast Distal Access Platform
Product Name: Mega Ballast
Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110
Software Version: N/A
Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flexible distal shaft. The design facilitates the advancement of the Mega Ballast to access the tortuous vasculature over a guidewire and a respective dilator. The outer surface of the Mega Ballast is coated with a hydrophilic coating to facilitate lubricity from tip to 40 cm proximal. The proximal end of the Mega Ballast incorporates a Luer fitting hub for the attachment of accessories. The Mega Ballast is provided sterile, non-pyrogenic, and is intended for single use only.
Component: Not a component
Reason: Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Root cause: Process control
Recalling firm: BALT USA, LLCType: Catheter, PercutaneousDistribution: US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT.Recall #Z-0188-2026
Open, ClassifiedPosted Oct 24, 2025·Initiated Aug 5, 2025
Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE
8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE
8065753179 UNITY 25+ HYPERVIT 30K VIT PROBE
Software Version: N/A
Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.
Component: N/A
Reason: Due to incomplete seals in the pouch which provide the sterile barrier.
Root cause: Process control
Recalling firm: Alcon Research LLCType: Vitrectomy, Instrument CutterDistribution: Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI, and WV; and OUS (foreign) to countries of: Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Brunei, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Kosovo, Luxembourg, Malaysia, Mexico, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom,Recall #Z-0304-2026
Open, ClassifiedPosted Oct 24, 2025·Initiated Aug 5, 2025
Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065750918 PAK,I/A LINE,NGVS
8065750957 ASSY,SHIP,CONSTELLATION VFC
8065750972 ENDOILLUMATOR,RFID,23G
8065751014 CONST AUTO GAS FILL PAK
8065751014 CONST AUTO GAS FILL PAK
8065751441 ENDOILLUMINATOR,RFID,25G
8065751577 CHANDELIER,25GA,W/RFID
Software Version: N/A
Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.
Component: N/A
Reason: Due to incomplete seals in the pouch which provide the sterile barrier.
Root cause: Process control
Recalling firm: Alcon Research LLCType: Unit, PhacofragmentationDistribution: Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI, and WV; and OUS (foreign) to countries of: Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Brunei, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Kosovo, Luxembourg, Malaysia, Mexico, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom,Recall #Z-0305-2026
Open, ClassifiedPosted Oct 24, 2025·Initiated Aug 5, 2025
Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK
Software Version: N/A
Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.
Component: N/A
Reason: Due to incomplete seals in the pouch which provide the sterile barrier.
Root cause: Process control
Recalling firm: Alcon Research LLCType: Instrument, Vitreous Aspiration And Cutting, Ac-PoweredDistribution: Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI, and WV; and OUS (foreign) to countries of: Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Brunei, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Kosovo, Luxembourg, Malaysia, Mexico, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom,Recall #Z-0306-2026
Open, ClassifiedPosted Oct 24, 2025·Initiated Aug 5, 2025
Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000252 UNITY 27 GA CHANDELIER
8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE
Software Version: N/A
Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.
Component: N/A
Reason: Due to incomplete seals in the pouch which provide the sterile barrier.
Root cause: Process control
Recalling firm: Alcon Research LLCType: EndoilluminatorDistribution: Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI, and WV; and OUS (foreign) to countries of: Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Brunei, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Kosovo, Luxembourg, Malaysia, Mexico, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom,Recall #Z-0307-2026
Open, ClassifiedPosted Oct 24, 2025·Initiated Aug 5, 2025
Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT
8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT
8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT
8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD
8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD
Software Version: N/A
Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.
Component: N/A
Reason: Due to incomplete seals in the pouch which provide the sterile barrier.
Root cause: Process control
Recalling firm: Alcon Research LLCType: Cannula, Trocar, OphthalmicDistribution: Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI, and WV; and OUS (foreign) to countries of: Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Brunei, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Kosovo, Luxembourg, Malaysia, Mexico, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom,Recall #Z-0308-2026
Open, ClassifiedPosted Oct 24, 2025·Initiated Sep 24, 2025
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
Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Root cause: Under Investigation by firm
Recalling firm: Aesculap IncType: Laparoscope, General & Plastic SurgeryDistribution: 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.Recall #Z-0309-2026
Open, ClassifiedPosted Oct 24, 2025·Initiated Sep 24, 2025
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
Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Root cause: Under Investigation by firm
Recalling firm: Aesculap IncType: Laparoscope, General & Plastic SurgeryDistribution: 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.Recall #Z-0310-2026
Open, ClassifiedPosted Oct 24, 2025·Initiated Sep 24, 2025
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
Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Root cause: Under Investigation by firm
Recalling firm: Aesculap IncType: Laparoscope, General & Plastic SurgeryDistribution: 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.Recall #Z-0311-2026
Open, ClassifiedPosted Oct 24, 2025·Initiated Sep 24, 2025
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
Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Root cause: Under Investigation by firm
Recalling firm: Aesculap IncType: Laparoscope, General & Plastic SurgeryDistribution: 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.Recall #Z-0312-2026
Open, ClassifiedPosted Oct 24, 2025·Initiated Oct 1, 2025
Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07.
Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Reason: Potential for contamination with cotton fibers.
Root cause: Process control
Recalling firm: ENDOMAGNETICS LTDType: Marker, Radiographic, ImplantableDistribution: Worldwide - US Nationwide distribution in the states of CA, CO, CT, DC, FL, GA, IA, ID, IN, KY, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, TX, WA and the country of Canada.Recall #Z-0316-2026
Open, ClassifiedPosted Oct 24, 2025·Initiated Oct 1, 2025
Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12.
Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Reason: Potential for contamination with cotton fibers.
Root cause: Process control
Recalling firm: ENDOMAGNETICS LTDType: Marker, Radiographic, ImplantableDistribution: Worldwide - US Nationwide distribution in the states of CA, CO, CT, DC, FL, GA, IA, ID, IN, KY, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, TX, WA and the country of Canada.Recall #Z-0317-2026
CompletedPosted Oct 24, 2025·Initiated Sep 16, 2025
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Reason: 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.
Root cause: Under Investigation by firm
Recalling firm: Surgical Theater IncType: System, Image Processing, RadiologicalDistribution: Worldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA, TX, NJ, PA, AZ, NY, KY, IN, WV and the countries of Italy, Germany, Israel, UK.Recall #Z-0319-2026