Medical DeviceJun 18, 2025
Tecfen Medical 20G (1.2mm) MVR Sideport Knife Straight recall — FDA Z-1953-2025
Sterility assurance for Ophthalmic knives.
Class IIFDA: OngoingTecfen Medical
June 2025 recalls — page 3
These records include useful source details for the selected month.
Medical DeviceJun 18, 2025
GE Medical Systems Information Technologies MUSE 5 Systems, Model Numbers 2021274-001 recall — FDA Z-1938-2025
The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate…
Class IIFDA: OngoingGE Medical Systems Information Technologies Inc.
Medical DeviceJun 18, 2025
Philips Intera Achieva 1.5T Pulsar recall — FDA Z-1935-2025
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If…
Class IIFDA: OngoingPhilips North America
Medical DeviceJun 18, 2025
Philips Intera 1.5T Achieva Nova Product Number: 781172 recall — FDA Z-1930-2025
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If…
Class IIFDA: OngoingPhilips North America
Medical DeviceJun 18, 2025
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running recall — FDA Z-1926-2025
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl…
Class IIFDA: OngoingBeckman Coulter, Inc.
Medical DeviceJun 18, 2025
Belmont Instrument Allon 2001. Part Number: 200-00263 recall — FDA Z-1966-2025
An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from…
Class IIFDA: OngoingBelmont Instrument LLC
Medical DeviceJun 18, 2025
Cardinal Health 200 Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with recall — FDA Z-1918-2025
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Class IIFDA: CompletedCardinal Health 200, LLC
Medical DeviceJun 18, 2025
Stryker GmbH Femoral Nail, RIGHT T2 GTN 8x300 mm recall — FDA Z-1940-2025
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but…
Class IIFDA: OngoingStryker GmbH
Medical DeviceJun 18, 2025
Cardinal Health 200 Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with recall — FDA Z-1919-2025
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Class IIFDA: CompletedCardinal Health 200, LLC
Medical DeviceJun 18, 2025
Covidien Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR recall — FDA Z-1915-2025
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an…
Class IFDA: OngoingCovidien
Medical DeviceJun 18, 2025
Stryker GmbH Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System recall — FDA Z-1914-2025
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Class IIFDA: OngoingStryker GmbH
Medical DeviceJun 18, 2025
Tecfen Medical 2.8mm Slit Knife, Angled recall — FDA Z-1952-2025
Sterility assurance for Ophthalmic knives.
Class IIFDA: OngoingTecfen Medical
Medical DeviceJun 18, 2025
Guardian System 2 Controller recall — FDA Z-1967-2025
A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
Class IIFDA: OngoingTurncare, Inc.
Medical DeviceJun 18, 2025
Stryker GmbH Femoral Nail, LEFT T2 GTN 8x300 mm recall — FDA Z-1939-2025
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but…
Class IIFDA: OngoingStryker GmbH
Medical DeviceJun 18, 2025
BD SWITZERLAND SARL Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium recall — FDA Z-1970-2025
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the…
Class IIFDA: OngoingBD SWITZERLAND SARL
Medical DeviceJun 18, 2025
Tecfen Medical 15 degree Stab Knife recall — FDA Z-1949-2025
Sterility assurance for Ophthalmic knives.
Class IIFDA: OngoingTecfen Medical
Medical DeviceJun 18, 2025
BD SWITZERLAND SARL BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241 recall — FDA Z-1974-2025
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the…
Class IIFDA: OngoingBD SWITZERLAND SARL
Medical DeviceJun 18, 2025
Cardinal Health 200 SCD Comfort Knee Length Small, SKU 84021 recall — FDA Z-1917-2025
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Class IIFDA: CompletedCardinal Health 200, LLC
Medical DeviceJun 18, 2025
Baxter Novum IQ Syringe Pump, product code 40800BAXUS recall — FDA Z-1964-2025
Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJun 18, 2025
Philips Intera 1.5T Achieva IT Nova Product Number: 781175 recall — FDA Z-1929-2025
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If…
Class IIFDA: OngoingPhilips North America
Medical DeviceJun 18, 2025
Philips SmartPath to dStream for 1.5T recall — FDA Z-1936-2025
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If…
Class IIFDA: OngoingPhilips North America
Medical DeviceJun 18, 2025
Philips Intera 1.5T Explorer/Nova Dual Product Number: 781108 recall — FDA Z-1932-2025
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If…
Class IIFDA: OngoingPhilips North America
Medical DeviceJun 18, 2025
Baxter Healthcare 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN recall — FDA Z-1962-2025
The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJun 18, 2025
Tecfen Medical 2.0mm Crescent Knife Angled Bevel Up recall — FDA Z-1954-2025
Sterility assurance for Ophthalmic knives.
Class IIFDA: OngoingTecfen Medical
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.