Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips S7-2 Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2059-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips S7-3t Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2060-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips S8-3t Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2061-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips V6-2 Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2062-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips VL13-5 Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2063-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips X5-1 Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2064-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips X6-1 Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2065-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips X7-2t Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2066-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips X8-2t Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2067-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 28, 2025
Philips XL14-3 Transducer.
Reason: Ultrasound transducer devices were refurbished beyond their useful life.
Root cause: Process control
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.Recall #Z-2068-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 23, 2025
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
Reason: Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
Root cause: Nonconforming Material/Component
Recalling firm: CORIN MEDICAL, LTD.Type: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: US Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT.Recall #Z-2069-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 12, 2025
The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial.
Reason: Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: HemoCue ABType: Glucose Oxidase, GlucoseDistribution: US Nationwide distribution in the state of AR.Recall #Z-2070-2025 Open, ClassifiedPosted Jul 2, 2025·Initiated May 22, 2025
Change Healthcare Cardiology Hemo Software
Reason: Due to complaints, software update may cause software to unexpectedly shutdown.
Root cause: Software design
Recalling firm: CHANGE HEALTHCARE CANADA COMPANYType: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.Recall #Z-2071-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated May 22, 2025
Change Healthcare Cardiology Hemodynamics Software
Reason: Due to complaints, software update may cause software to unexpectedly shutdown.
Root cause: Software design
Recalling firm: CHANGE HEALTHCARE CANADA COMPANYType: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.Recall #Z-2072-2025
Open, ClassifiedPosted Jul 2, 2025·Initiated Jun 12, 2025
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.
Reason: Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.
Root cause: Under Investigation by firm
Recalling firm: Ortho-Clinical Diagnostics, Inc.Type: Enzyme Immunoassay, OpiatesDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.Recall #Z-2073-2025
Open, ClassifiedPosted Jun 30, 2025·Initiated May 23, 2025
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as:
1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B;
2) CC ADULT DRAWER 2, REF ACC010256;
3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A;
4) ADULT DRAWER 4, REF ACC010389C;
5) DRAWER 4 - SUMMIT, REF ACC010627;
6) DRAWER 3, REF ACC010898.
Reason: Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.Recall #Z-2043-2025
Open, ClassifiedPosted Jun 30, 2025·Initiated May 23, 2025
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
Reason: Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: I.V. Start KitDistribution: US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.Recall #Z-2044-2025
Open, ClassifiedPosted Jun 30, 2025·Initiated May 23, 2025
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
Reason: Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Eye TrayDistribution: US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.Recall #Z-2045-2025
Open, ClassifiedPosted Jun 30, 2025·Initiated May 7, 2025
Brand Name: Valeda Light Delivery System
Product Name: Light Based Device for Dry Age Related Macular Degeneration
Product Description: Light Based Device for Dry Age Related Macular Degeneration
Component: No
Reason: U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
Root cause: Under Investigation by firm
Recalling firm: LUMITHERA INCType: Light Based Device For Dry Age-Related Macular DegenerationDistribution: US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.Recall #Z-2046-2025
Open, ClassifiedPosted Jun 27, 2025·Initiated May 30, 2025
Servo-u Ventilator System. Model Number: 6688600.
Reason: Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Root cause: Under Investigation by firm
Recalling firm: Maquet Critical Care ABType: Ventilator, Continuous, Facility UseDistribution: US Nationwide distribution and Puerto Rico. No international distribution.Recall #Z-2013-2025