Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2563-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2564-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2565-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2566-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2567-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2568-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2569-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2570-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2571-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2572-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2573-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated May 27, 2026
Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack
Model/Catalog Number: STP-AT-012
Software Version: N/A
Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack
Component: Dexcom G7 Continuous Glucose Monitoring System
Reason: Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.
Root cause: Nonconforming Material/Component
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: Dexcom does not have distribution records for this product due to its unauthorized release. However Dexcom is able to identify sensor session starts for the affected lots through the Dexcom G7 CGM App user performance data.
Based on App user performance data, Lot 1725204004 has sensor session starts in the United States.
Based on App user performance data, Lot 1725069002 has sensor session starts in the United States and the countries of Australia, Austria, Canada, Czech Republic, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, South Korea, Kuwait, Netherlands, Poland, Portugal, Qatar, Singapore, Spain, Switzerland, Turkey, United Arab Emirates,and the United Kingdom.Recall #Z-2574-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated May 12, 2026
Octopus Evolution Tissue Stabilizer, Model TS2000
Reason: During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Root cause: Under Investigation by firm
Recalling firm: Medtronic Perfusion SystemsType: Stabilizer, HeartDistribution: Worldwide - US Nationwide distribution.Recall #Z-2575-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated May 12, 2026
Octopus Evolution AS Tissue Stabilizer, Model TS2500
Reason: During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Root cause: Under Investigation by firm
Recalling firm: Medtronic Perfusion SystemsType: Stabilizer, HeartDistribution: Worldwide - US Nationwide distribution.Recall #Z-2576-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated May 12, 2026
Octopus 4 Tissue Stabilizer, Model 29400
Reason: During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Root cause: Under Investigation by firm
Recalling firm: Medtronic Perfusion SystemsType: Stabilizer, HeartDistribution: Worldwide - US Nationwide distribution.Recall #Z-2577-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated May 11, 2026
Brand Name: Persona Revision
Product Name: Persona Revision Trabecular Metal Femoral Distal Augment
Model/Catalog Number: 42-5572-066-10
Software Version: N/A
Product Description: Persona Revision Trabecular Metal Femoral Distal Augment Size 9, 9+ 10mm Thicknes
Component: N/A
Reason: Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Root cause: Labeling Change Control
Recalling firm: Zimmer, Inc.Type: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerDistribution: Refer to the attached ZFA 2026-00088_Initial Consignee List and ZFA 2026-00088_Initial Distribution History containing the distribution and the identification of the affected consignees.Recall #Z-2578-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Jun 5, 2026
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.
Reason: Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
Root cause: Software design
Recalling firm: Philips North America LlcType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN.Recall #Z-2579-2026 Open, ClassifiedPosted Jun 23, 2026·Initiated May 8, 2026
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Reason: Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
Root cause: Vendor change control
Recalling firm: Ventec Life Systems, Inc.Type: Ventilator, Continuous, Facility UseDistribution: US Nationwide distribution in the state of UT.Recall #Z-2525-2026
Open, ClassifiedPosted Jun 23, 2026·Initiated Apr 21, 2026
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Reason: A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation.
Root cause: Under Investigation by firm
Recalling firm: PFM MEDICAL INC.Type: Catheter, EmbolectomyDistribution: US Nationwide distribution in the states of NY, MD.Recall #Z-2526-2026
Open, ClassifiedPosted Jun 23, 2026·Initiated May 20, 2026
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Reason: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Root cause: Under Investigation by firm
Recalling firm: Zimmer, Inc.Type: Shoulder Prosthesis, Reverse ConfigurationDistribution: US Nationwide distribution.Recall #Z-2527-2026