Open, ClassifiedPosted Sep 4, 2025·Initiated Aug 7, 2025
FloPatch FP120, REF: FP120-FOT01-005
Reason: Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.
Root cause: Labeling Change Control
Recalling firm: Flosonics Medical (R/A 1929803 ONTARIO CORP.)Type: Flowmeter, Blood, CardiovascularDistribution: US Nationwide distribution in the state of California.Recall #Z-2517-2025
Open, ClassifiedPosted Sep 4, 2025·Initiated Aug 11, 2025
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1
Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology.
Reason: Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client (Pressure Sensor Defective) during non-invasive blood pressure (NIBP) measurements, specifically when the initial inflation pressure is set in the high-pressure range (>240 mmHg). The ARGUS PB-3000 is a vital signs monitoring instrument intended to be integrated into the Merge Hemo System. No other components of the Merge Hemo System are affected.
Root cause: Process control
Recalling firm: Merge Healthcare, Inc.Type: Computer, Diagnostic, ProgrammableDistribution: US Nationwide distribution including in the states of Arizona, Arkansas, California, Florida, Louisiana, Mississippi, North Carolina, North Dakota, Oklahoma, Pennsylvania, Georgia, Illinois, Kentucky, Tennessee, Texas, Washington, and Wisconsin.Recall #Z-2518-2025
Open, ClassifiedPosted Sep 4, 2025·Initiated Jul 31, 2025
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly
Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly
Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly
Software Version: Not Applicable
Product Description: Sterile Cover
Component: Lumicell Direct Visualization System (DVS) / PMA # P230014
Reason: The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies in the surgical cavity and potentially leading to surgical site infections.
Root cause: Under Investigation by firm
Recalling firm: Lumicell, Inc.Type: Fluorescence Imaging For Breast Cancer DetectionDistribution: US Nationwide distribution in the states of CA, FL, MA, NC, TX.Recall #Z-2519-2025
Open, ClassifiedPosted Sep 4, 2025·Initiated Jul 17, 2025
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029
Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Reason: Surgical drape packs may have open seals, which may compromise the sterility of the product.
Root cause: Process control
Recalling firm: O&M HALYARD INCType: Drape, Surgical, AntimicrobialDistribution: Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.Recall #Z-2520-2025
Open, ClassifiedPosted Sep 4, 2025·Initiated Jun 17, 2025
MI Cancer Seek REF MSC000
UDI Code: (01)00860008613325(21)H5HJHDSXF
MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.
Reason: Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Root cause: Software design
Recalling firm: CARIS LIFE SCIENCESType: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemDistribution: U.S. Nationwide distribution in the state of NY.Recall #Z-2521-2025
Open, ClassifiedPosted Sep 4, 2025·Initiated Aug 6, 2025
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-2522-2025
Open, ClassifiedPosted Sep 4, 2025·Initiated Aug 6, 2025
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-2523-2025
Open, ClassifiedPosted Sep 4, 2025·Initiated Aug 6, 2025
Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-2524-2025
Open, ClassifiedPosted Sep 4, 2025·Initiated Aug 6, 2025
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-2525-2025
Open, ClassifiedPosted Sep 4, 2025·Initiated Aug 6, 2025
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-2526-2025
Open, ClassifiedPosted Sep 4, 2025·Initiated Aug 6, 2025
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24
Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-2527-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Aug 6, 2025
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Reason: The catheters may not retain their shape.
Root cause: Process change control
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Worldwide - US Nationwide distribution.Recall #Z-2480-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Aug 6, 2025
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Reason: The catheters may not retain their shape.
Root cause: Process change control
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Worldwide - US Nationwide distribution.Recall #Z-2481-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Aug 6, 2025
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Reason: The catheters may not retain their shape.
Root cause: Process change control
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Worldwide - US Nationwide distribution.Recall #Z-2482-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Aug 1, 2025
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers:
1. Azurion 3 M12, Model Number 722063.
2. Azurion 3 M15, Model Number 722064.
3. Azurion 7 B12, Model Number 722067.
4. Azurion 7 B20, Model Number 722068.
5. Azurion 7 M12, Model Number 722078.
6. Azurion 7 M20, Model Number 722079.
7. Azurion 3 M12, Model Number 722221.
8. Azurion 3 M15, Model Number 722222.
9. Azurion 7 M12, Model Number 722223.
10. Azurion 7 M20, Model Number 722224.
11. Azurion 7 B12, Model Number 722225.
12. Azurion 7 B20, Model Number 722226.
13. Azurion 5 M12, Model Number 722227.
14. Azurion 5 M20, Model Number 722228.
15. Azurion 7 M20, Model Number 722282.
Reason: Philips Azurion and Allura systems configured
with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
Root cause: Under Investigation by firm
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Latvia, Lithuania, Macedonia, Maldives, Malta, Mexico, Moldova, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Panama, Paraguay, Peru, Philippines, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.Recall #Z-2502-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Aug 1, 2025
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x).
Labeled as the following with corresponding model numbers:
1. Allura Xper FD10, Model Number 722003
2. Allura Xper FD10/10, Model Number 722005
3. Allura Xper FD20, Model Number 722006
4. Allura Xper FD20 Biplane, Model Number 722008
5. Allura Xper FD10, Model Number 722010
6. Allura Xper FD10/10, Model Number 722011
7. Allura Xper FD20, Model Number 722012
8. Allura Xper FD20 Biplane, Model Number 722013
9. Allura Xper FD20 OR Table, Model Number 722023
10. Allura Xper FD10, Model Number 722026
11. Allura Xper FD10/10, Model Number 722027
12. Allura Xper FD20, Model Number 722028
13. Allura Xper FD20/10, Model Number 722029
14. Allura Xper FD20 OR Table, Model Number 722035
15. Allura Xper FD20/20, Model Number 722038
16. Allura Xper FD20/15, Model Number 722058
17. Allura Xper FD20/15 OR Table, Model Number 722059.
Reason: Philips Azurion and Allura systems configured
with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
Root cause: Under Investigation by firm
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Latvia, Lithuania, Macedonia, Maldives, Malta, Mexico, Moldova, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Panama, Paraguay, Peru, Philippines, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.Recall #Z-2503-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Aug 1, 2025
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers:
1. Allura Xper FD10, Model Number 722003.
2. Allura Xper FD10/10, Model Number 722005.
3. Allura Xper FD20, Model Number 722006.
4. Allura Xper FD20 Biplane, Model Number 722008.
5. Allura Xper FD10, Model Number 722010.
6. Allura Xper FD10/10, Model Number 722011.
7. Allura Xper FD20, Model Number 722012.
8. Allura Xper FD20 Biplane, Model Number 722013.
9. Allura Xper FD20 OR Table, Model Number 722023.
10. Allura Xper FD10, Model Number 722026.
11. Allura Xper FD10/10, Model Number 722027.
12. Allura Xper FD20, Model Number 722028.
13. Allura Xper FD20/10, Model Number 722029.
14. Allura Xper FD20 OR Table, Model Number 722035.
15. Allura Xper FD20/20, Model Number 722038.
16. Allura Xper FD20/15, Model Number 722058.
510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859.
Reason: Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
Root cause: Under Investigation by firm
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, HI, ID, IL, KS, KY, LA, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI, WV and the countries of Argentina, Austria, Australia, Belgium, Switzerland, Chile, China, Colombia, Czechia, Germany, Egypt, Spain, Finland, France, United Kingdom, Hong Kong, India, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Norway, Oman, Pakistan, Poland, Romania, Saudi Arabia, Sweden, Singapore, Thailand, Vietnam.Recall #Z-2504-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Aug 5, 2025
Brand Name: MediHoney
Product Name: MediHoney Paste
Model/Catalog Number: 31505
Product Description: MediHoney Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used.
Reason: Packaging failures were identified which could lead to a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Dressing, Wound, DrugDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.Recall #Z-2505-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Aug 5, 2025
Brand Name: MediHoney
Product Name: MediHoney Tube
Model/Catalog Number: 31515 and 31535
Product Description: MediHoney Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used.
Reason: Packaging failures were identified which could lead to a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Dressing, Wound, DrugDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.Recall #Z-2506-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Aug 5, 2025
Brand Name: MediHoney
Product Name: MediHoney HCS Sheet Dressing with Leptospermum
Model/Catalog Number: 31612, 31622, 31644
Product Description: MEDIHONEY HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel collodial gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does require a secondary dressing.
Reason: Packaging failures were identified which could lead to a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Dressing, Wound, DrugDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.Recall #Z-2507-2025