Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW
Model/Catalog Number: 7170-24
Product Description: Feeding Tube Kit
Component: No
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2343-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL
Model/Catalog Number: 7180-14
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2344-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL
Model/Catalog Number: 7180-20
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2345-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL
Model/Catalog Number: 7180-24
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2346-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW
Model/Catalog Number: 8170-14
Product Description: Feeding Tube Kit
Component: No
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2347-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW
Model/Catalog Number: 8170-20
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2348-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW
Model/Catalog Number: 8170-24
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2349-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL
Model/Catalog Number: 8180-14
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2350-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL
Model/Catalog Number: 8180-20
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2351-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL
Model/Catalog Number: 8180-24
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2352-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated May 4, 2026
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
Reason: Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel modules with firmware 2021.02, 2022.01 or 2022.02 in a multi-module SEEG configuration, potentially leading to misinterpretation of results.
Root cause: Software Design Change
Recalling firm: Micromed S.p.A.Type: Full-Montage Standard ElectroencephalographDistribution: Worldwide - US Nationwide distribution in the states of FL, PA.Recall #Z-2353-2026
Open, ClassifiedPosted Jun 5, 2026·Initiated May 1, 2026
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
Reason: System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
Root cause: Device Design
Recalling firm: Philips North America LlcType: Solid State X-Ray Imager (Flat Panel/Digital Imager)Distribution: US distribution to California.Recall #Z-2354-2026 Open, ClassifiedPosted Jun 4, 2026·Initiated Mar 9, 2026
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Reason: During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0,
an actual x-ray dose is applied to the patient.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: US and WorldwideRecall #Z-2205-2026
Open, ClassifiedPosted Jun 4, 2026·Initiated Mar 9, 2026
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
Reason: During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior
has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0,
an actual x-ray dose is applied to the patient.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: US and WorldwideRecall #Z-2206-2026
Open, ClassifiedPosted Jun 4, 2026·Initiated May 7, 2026
Atlan A350. Model Number: 8211500. anesthesia workstation
Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Root cause: Process change control
Recalling firm: Draeger, Inc.Type: Gas-Machine, AnesthesiaDistribution: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, YemenRecall #Z-2207-2026
Open, ClassifiedPosted Jun 4, 2026·Initiated May 7, 2026
Atlan A350XL. Model Number: 8621600. anesthesia workstation
Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Root cause: Process change control
Recalling firm: Draeger, Inc.Type: Gas-Machine, AnesthesiaDistribution: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, YemenRecall #Z-2208-2026
Open, ClassifiedPosted Jun 4, 2026·Initiated May 4, 2026
Pediatric care bed;
Product Designation: KayserBett IDA;
Reason: If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even death of the patient (child) or third parties (children).
Root cause: Device Design
Recalling firm: KAYSERBETTEN GMBH & CO. KGType: Bed, Ac-Powered Adjustable HospitalDistribution: Distribution US Nationwide and Canada.Recall #Z-2212-2026
Open, ClassifiedPosted Jun 4, 2026·Initiated Apr 3, 2026
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L
Model/Catalog Number: 409-375
Product Description: Stapes Prosthesis
Reason: Due to incorrect functional length on device labeling.
Root cause: Process control
Recalling firm: Grace Medical, Inc.Type: Prosthesis, Partial Ossicular ReplacementDistribution: U.S Nationwide distribution in the state of MD.Recall #Z-2308-2026
Open, ClassifiedPosted Jun 4, 2026·Initiated Apr 23, 2026
Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL
Model/Catalog Number: 72-2231
Microsurgical Knife
Reason: 3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
Root cause: Mixed-up of materials/components
Recalling firm: SSC- Surgical Specialties CorporationType: Knife, OphthalmicDistribution: Worldwide - US Nationwide distribution in the states of Texas, Utah, Michigan and the countries of Turkey, Germany, Romania, Poland, United Kingdom.Recall #Z-2309-2026
Open, ClassifiedPosted Jun 4, 2026·Initiated Apr 24, 2026
Brand Name: Da Vinci 5
Product Name: ASSY,DV5 TOWER,IS5000
Model/Catalog Number: 380746
Software Version: N/A
Product Description: Preface:
This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system.
Product Description:
The NIR handheld camera system is compatible for use with the da Vinci 5 system to aid in
surgery. The components of the NIR handheld camera system include a camera control unit
and a light source, NIR handheld camera, and additional components that together, connect
to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from
the NIR handheld camera system is displayed on the Tower monitor.
Component: Yes, the SOCK is the component and integrated into the dV5 system
Reason: Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
Root cause: Device Design
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
O.U.S.: Australia, Belgium, France, Germany, Italy, Japan, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, South Korea, Spain, Switzerland, and United KingdomRecall #Z-2310-2026