Open, ClassifiedPosted Mar 11, 2025·Initiated Feb 24, 2025
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Reason: Device is missing the pin in the graft loader component.
Root cause: Employee error
Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson Co.Type: Orthopedic Manual Surgical InstrumentDistribution: Domestic: Nationwide Distribution; Foreign: Austria, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Spain, Finland, France, French Guyana, Greece, Israel, India, Italy, Japan, South Korea, Luxemburg, Mexico, Netherlands, Poland, Portugal & Singapore.Recall #Z-1314-2025
Open, ClassifiedPosted Mar 11, 2025·Initiated Feb 24, 2025
COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Reason: Device is missing the pin in the graft loader component.
Root cause: Employee error
Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson Co.Type: Orthopedic Manual Surgical InstrumentDistribution: Domestic: Nationwide Distribution; Foreign: Austria, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Spain, Finland, France, French Guyana, Greece, Israel, India, Italy, Japan, South Korea, Luxemburg, Mexico, Netherlands, Poland, Portugal & Singapore.Recall #Z-1315-2025
Open, ClassifiedPosted Mar 10, 2025·Initiated Feb 7, 2025
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is
introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory
Model: 18-5000
Reason: Damage to the sterile barrier pouch of catheter, which could potentially compromise
its sterility.
Root cause: Process control
Recalling firm: CardioFocus, Inc.Type: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationDistribution: Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic,
Italy, Japan, United Kingdom.Recall #Z-1307-2025 Open, ClassifiedPosted Mar 7, 2025·Initiated Feb 18, 2025
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Reason: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
Root cause: Process change control
Recalling firm: GE Medical Systems, LLCType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution.Recall #Z-1297-2025
Open, ClassifiedPosted Mar 7, 2025·Initiated Feb 18, 2025
GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
Reason: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
Root cause: Process change control
Recalling firm: GE Medical Systems, LLCType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution.Recall #Z-1298-2025
Open, ClassifiedPosted Mar 7, 2025·Initiated Feb 18, 2025
GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
Reason: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
Root cause: Process change control
Recalling firm: GE Medical Systems, LLCType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution.Recall #Z-1299-2025
Open, ClassifiedPosted Mar 7, 2025·Initiated Feb 18, 2025
GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
Reason: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
Root cause: Process change control
Recalling firm: GE Medical Systems, LLCType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution.Recall #Z-1300-2025
Open, ClassifiedPosted Mar 7, 2025·Initiated Feb 18, 2025
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
Reason: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
Root cause: Process change control
Recalling firm: GE Medical Systems, LLCType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution.Recall #Z-1301-2025
Open, ClassifiedPosted Mar 7, 2025·Initiated Feb 18, 2025
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
Reason: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
Root cause: Process change control
Recalling firm: GE Medical Systems, LLCType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution.Recall #Z-1302-2025
Open, ClassifiedPosted Mar 7, 2025·Initiated Feb 18, 2025
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
Reason: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
Root cause: Process change control
Recalling firm: GE Medical Systems, LLCType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution.Recall #Z-1303-2025
Open, ClassifiedPosted Mar 6, 2025·Initiated Feb 5, 2025
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
Reason: There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Root cause: Under Investigation by firm
Recalling firm: Baxter Healthcare CorporationType: Pump, InfusionDistribution: US: NationwideRecall #Z-1253-2025
Open, ClassifiedPosted Mar 6, 2025·Initiated Feb 5, 2025
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Reason: There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Root cause: Under Investigation by firm
Recalling firm: Baxter Healthcare CorporationType: Pump, InfusionDistribution: US: NationwideRecall #Z-1254-2025
Open, ClassifiedPosted Mar 6, 2025·Initiated Aug 9, 2024
Vios Monitoring System Bedside Monitor Model BSM2050
Reason: Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues.
Root cause: Labeling design
Recalling firm: Murata Vios, Inc.Type: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Distribution: US Nationwide distribution in the states of Florida, Louisiana, Maryland, Montana, New York, Ohio, and Texas.Recall #Z-1292-2025
Open, ClassifiedPosted Mar 6, 2025·Initiated Feb 10, 2025
Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09
Reason: Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur.
Root cause: Software design
Recalling firm: Alcon Research LLCType: General Surgery TrayDistribution: US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI.Recall #Z-1293-2025
Open, ClassifiedPosted Mar 6, 2025·Initiated Jan 27, 2025
TISSUE APPROXIMATION SYSTEM (TAS),
Models T-4000, T-5000, T-LAP
Reason: Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution for 60 min prior to implantation to rehydrate the zip-tie straps. Broken zip-ties not observed during procedure could lead to future hernia recurrence, recurrent surgery to correct a large herniation.
Root cause: Device Design
Recalling firm: TAS Medical IncType: Suture, Nonabsorbable, Synthetic, PolyamideDistribution: US Nationwide distribution in the states of LA, OK, TN.Recall #Z-1294-2025
Open, ClassifiedPosted Mar 6, 2025·Initiated Feb 6, 2025
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Reason: Possibility for the obturator to break (separate).
Root cause: Process control
Recalling firm: Integra LifeSciences Corp.Type: Endoscope, NeurologicalDistribution: US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA, MN, WA, TN, MD, LA, OK, SC, PA, MI, KY, NC, DC.Recall #Z-1295-2025
Open, ClassifiedPosted Mar 6, 2025·Initiated Feb 12, 2025
BD BBL TB Stain Kit K, Catalog (REF): 212522
Reason: One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.
Root cause: Under Investigation by firm
Recalling firm: Becton Dickinson & Co.Type: Stains, MicrobiologicDistribution: Domestic: AZ, CA, CO, GA, KY, IL, IN, NC, NJ, NY, MA, MD, TX, WA.
International: Singapore, New Zealand, Chile, Australia, Taiwan, Malaysia.Recall #Z-1296-2025
Open, ClassifiedPosted Mar 5, 2025·Initiated Feb 5, 2025
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex:
S 6 F x 110 cm, REF: 80236;
S 6 F x 135 cm, REF: 80237;
S 8 F x 85 cm, REF: 80238;
S 8 F x 110 cm, REF: 80239
Reason: Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.
Root cause: Under Investigation by firm
Recalling firm: Bard Peripheral Vascular IncType: Catheter, Peripheral, AtherectomyDistribution: US Nationwide Distribution: NY, VA, KY, IN, OR, FL, MD, NJ, LA, CO, PR, PA, MS, MI, TX, KS, IL, CA, GA, OH, AL, NC, ND, AZ, SC, TN, UT, AR, WI, SD, MA, MO, ME, DE, WV , NV, NH, MN, CT, NE, IA, NM, WA, HI, and OKRecall #Z-1244-2025
Open, ClassifiedPosted Mar 5, 2025·Initiated Jan 30, 2025
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50
Reason: Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age
Root cause: Device Design
Recalling firm: Micro Therapeutics, Inc.Type: Intracranial Aneurysm Flow DiverterDistribution: Worldwide distribution: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, AL, NV, MN, NJ, IL, OH, AK, CT, TN, MO, TX, ID, AZ, WI, PA, OR, SD, VA, CO, GA, KY, IN, AR, MA, LA, NE, MT, ME, SC, DC, NC, ND, NM, IA, UT, KS, WV, NH, HI, RI. And OUS (foreign) countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Republic Of Moldova, Montenegro, Morocco, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam
Open, ClassifiedPosted Mar 5, 2025·Initiated Jan 30, 2025
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2
Reason: Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age
Root cause: Device Design
Recalling firm: Micro Therapeutics, Inc.Type: Intracranial Aneurysm Flow DiverterDistribution: Worldwide distribution: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, AL, NV, MN, NJ, IL, OH, AK, CT, TN, MO, TX, ID, AZ, WI, PA, OR, SD, VA, CO, GA, KY, IN, AR, MA, LA, NE, MT, ME, SC, DC, NC, ND, NM, IA, UT, KS, WV, NH, HI, RI. And OUS (foreign) countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Republic Of Moldova, Montenegro, Morocco, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, VietnamRecall #Z-1246-2025