Open, ClassifiedPosted May 1, 2026·Initiated Mar 11, 2026
Intuitive 8 mm SureForm 30 Gray Reloads
Reference Numbers: 48230M-05 and 48230M-06
Reason: Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Root cause: Under Investigation by firm
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: US: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin
OUS: Austria Belgium Denmark Finland France Germany Ireland Italy Japan Netherlands Norway Spain Sweden Switzerland United KingdomRecall #Z-1855-2026
Open, ClassifiedPosted May 1, 2026·Initiated Apr 2, 2026
Centimeter Sizing Catheter
RPN N5.0-35-100-P-10S-PIG-CSC-20
GPN G11916
Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque).
The choice of catheter material for different angiographic procedures should be based on the physician s experience.
Reason: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Root cause: Under Investigation by firm
Recalling firm: Cook IncorporatedType: Catheter, Intravascular, DiagnosticDistribution: US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, UruguayRecall #Z-1934-2026
Open, ClassifiedPosted May 1, 2026·Initiated Apr 2, 2026
Aurous Centimeter Sizing Catheter
RPN N5.0-35-100-P-10S-PIG-CSC-20-01
GPN G47308
Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).
Reason: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Root cause: Under Investigation by firm
Recalling firm: Cook IncorporatedType: Catheter, Intravascular, DiagnosticDistribution: US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, UruguayRecall #Z-1935-2026
Open, ClassifiedPosted May 1, 2026·Initiated Apr 2, 2026
Beacon Tip Centimeter Sizing Catheter
RPN/GPN
NR5.0-35-70-P-10S-0-CSC-20
G31213
NR5.0-35-100-P-10S-0-CSC-20
G31214
NR5.0-35-100-P-10S-PIG-CSC-20
G31216
NR5.0-35-70-P-10S-VCF-CSC-20
G31220
NR5.0-35-100-P-10S-VCF-CSC-20
G31221
Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).
Reason: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Root cause: Under Investigation by firm
Recalling firm: Cook IncorporatedType: Catheter, Intravascular, DiagnosticDistribution: US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, UruguayRecall #Z-1936-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 25, 2026
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Reason: Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk
Root cause: Process change control
Recalling firm: Ventec Life Systems, Inc.Type: Continuous, Ventilator, Home UseDistribution: US: OH, GA, CA, MORecall #Z-1942-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 13, 2026
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Reason: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiac Catheterization KitDistribution: US distribution to FL, IL, MO, MS, NC, NE, TX.Recall #Z-1970-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 13, 2026
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
Reason: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiac Catheterization KitDistribution: US distribution to FL, IL, MO, MS, NC, NE, TX.Recall #Z-1971-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 13, 2026
Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Reason: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiac Catheterization KitDistribution: US distribution to FL, IL, MO, MS, NC, NE, TX.Recall #Z-1972-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 13, 2026
Halyard CATH LAB kit. Model Number: SACL75AM.
Reason: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiac Catheterization KitDistribution: US distribution to FL, IL, MO, MS, NC, NE, TX.Recall #Z-1973-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 13, 2026
Halyard CATH LAB kit. Model Number: SACL75-01.
Reason: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Orthopedic TrayDistribution: US distribution to FL, IL, MO, MS, NC, NE, TX.Recall #Z-1974-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 13, 2026
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Reason: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiovascular Procedure KitDistribution: US distribution to FL, IL, MO, MS, NC, NE, TX.Recall #Z-1975-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 13, 2026
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
Reason: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiovascular Procedure KitDistribution: US distribution to FL, IL, MO, MS, NC, NE, TX.Recall #Z-1976-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 13, 2026
Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
Reason: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US distribution to FL, IL, MO, MS, NC, NE, TX.Recall #Z-1977-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 13, 2026
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
Reason: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiac Catheterization KitDistribution: US distribution to FL, IL, MO, MS, NC, NE, TX.Recall #Z-1978-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 13, 2026
Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
Reason: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiac Catheterization KitDistribution: US distribution to FL, IL, MO, MS, NC, NE, TX.Recall #Z-1979-2026
Open, ClassifiedPosted May 1, 2026·Initiated Apr 2, 2026
Brand Name: Da Vinci X and Da Vinci Xi
Product Name: da Vinci X, Xi Surgical System
Model/Catalog Number: IS4000; IS4200
Software Version: N/A
Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery.
Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
Reason: Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Root cause: Nonconforming Material/Component
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, 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, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.Recall #Z-2046-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 30, 2026
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Reason: For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)Distribution: Worldwide distribution - US Nationwide and the country of Belgium.Recall #Z-2048-2026 Open, ClassifiedPosted May 1, 2026·Initiated Mar 30, 2026
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
Reason: For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)Distribution: Worldwide distribution - US Nationwide and the country of Belgium.Recall #Z-2049-2026 Open, ClassifiedPosted May 1, 2026·Initiated Mar 20, 2026
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5
Total cervical disc replacement.
Reason: Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Root cause: Labeling mix-ups
Recalling firm: Centinel Spine, Inc.Type: Prosthesis, Intervertebral DiscDistribution: US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.Recall #Z-2050-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 20, 2026
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6.
Total cervical disc replacement.
Reason: Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Root cause: Labeling mix-ups
Recalling firm: Centinel Spine, Inc.Type: Prosthesis, Intervertebral DiscDistribution: US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.Recall #Z-2051-2026