July 2, 2025Medical DevicesFDA
Encore Medical, LP recalls Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-1
Hazard: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
July 2, 2025Medical DevicesFDA
Encore Medical, LP recalls Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-1
Hazard: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
July 2, 2025Medical DevicesFDA
Becton Dickinson Infusion Therapy Systems, Inc. recalls REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
Hazard: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
July 2, 2025Medical DevicesFDA
Becton Dickinson Infusion Therapy Systems, Inc. recalls REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOn
Hazard: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
July 2, 2025Medical DevicesFDA
Becton Dickinson Infusion Therapy Systems, Inc. recalls REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Hazard: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
July 2, 2025Medical DevicesFDA
Becton Dickinson Infusion Therapy Systems, Inc. recalls REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERIL
Hazard: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
July 2, 2025Medical DevicesFDA
Becton Dickinson Infusion Therapy Systems, Inc. recalls REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO,
Hazard: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
July 2, 2025Medical DevicesFDA
Becton Dickinson Infusion Therapy Systems, Inc. recalls REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Hazard: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
July 2, 2025Medical DevicesFDA
Becton Dickinson Infusion Therapy Systems, Inc. recalls REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
Hazard: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
July 2, 2025Medical DevicesFDA
Becton Dickinson Infusion Therapy Systems, Inc. recalls REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 m
Hazard: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
July 2, 2025Medical DevicesFDA
Becton Dickinson Infusion Therapy Systems, Inc. recalls REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Hazard: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
July 2, 2025Medical DevicesFDA
Jolife AB recalls LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult
Hazard: Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
July 2, 2025Medical DevicesFDA
BIGFOOT BIOMEDICAL recalls Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuratio
Hazard: Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision.
July 2, 2025Medical DevicesFDA
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer C11137
Hazard: Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
July 2, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Hazard: There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
July 2, 2025Medical DevicesFDA
Barco N.V. recalls Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300
Hazard: Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video and/or control signals might be interrupted or fall away, displays might switch to failover and back multiple times, devices/sources/sinks might not be discovered/available, might lead to delayed/prolonged procedures
July 2, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow So
Hazard: Lack of sterility assurance.
July 2, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Extended Tip Applicator 8CM, Box of 1.
Hazard: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
July 2, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Extended Tip Applicator, 15 CM, Box of 5.
Hazard: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
July 2, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Extended Tip Applicator, 8CM, Box of 5.
Hazard: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
July 2, 2025Medical DevicesFDA
SunMed Holdings, LLC recalls Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36
Hazard: The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
June 25, 2025Medical DevicesFDA
Diagnostica Stago, Inc. recalls STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent
Hazard: Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
June 25, 2025Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline,
Hazard: Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
June 25, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Plum Solos, Item number 400011001; infusion pump
Hazard: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
June 25, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Hazard: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
June 25, 2025Medical DevicesFDA
BALT USA, LLC recalls Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00
Hazard: Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
June 25, 2025Medical DevicesFDA
BALT USA, LLC recalls Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 0081006856885
Hazard: Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
June 25, 2025Medical DevicesFDA
Preat Corp recalls Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used i
Hazard: Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.
June 25, 2025Medical DevicesFDA
Chamberlain Technologies LLC recalls SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
Hazard: Potential presence of residual adhesive material on the mesh surface.
June 25, 2025Medical DevicesFDA
Chamberlain Technologies LLC recalls SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
Hazard: Potential presence of residual adhesive material on the mesh surface.