Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 3,851–3,900 of 8,689
- Class II
Medical Device Recall · May 28, 2025
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder deviPackage labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- Class II
Medical Device Recall · May 28, 2025
Philips L8-4 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips S8-3t Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 7A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).
- Class II
Medical Device Recall · May 28, 2025
Philips V6-2 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder deviPackage labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- Class II
Medical Device Recall · May 28, 2025
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder deviPackage labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- Class II
Medical Device Recall · May 28, 2025
Philips 3D9-3v Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips X6-1 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips X5-1 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips S7-3t Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips eL18-4 EMT Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips X7-2t Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips L12-4 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder deviPackage labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- Class II
Medical Device Recall · May 28, 2025
Philips C5-2 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips X8-2t Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips L12-3 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 27, 2025
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
- Class II
Medical Device Recall · May 27, 2025
Medtronic Navigation, Inc.-Boxborough
O-arm O2 Imaging System. Mobile X-Ray System.A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
- Class II
Medical Device Recall · May 23, 2025
Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to downlInsulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.
- Class II
Medical Device Recall · May 23, 2025
SIGNA Architect AIRGE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
- Class II
Medical Device Recall · May 23, 2025
Jewel Precision Sheet Metal & Machining Co, Inc.
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
- Class II
Medical Device Recall · May 23, 2025
SIGNA PET/MRGE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
- Class I
Medical Device Recall · May 23, 2025
Integra LifeSciences Corp. (NeuroSciences)
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.Lack of sterility assurance.
- Class II
Medical Device Recall · May 23, 2025
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instrumentDue to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
- Class II
Medical Device Recall · May 23, 2025
SIGNA ArchitectGE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
- Class II
Medical Device Recall · 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-5255Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
- Class II
Medical Device Recall · May 23, 2025
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-HThis is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
- Class II
Medical Device Recall · May 23, 2025
Discovery MR750w 3.0TGE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
- Class II
Medical Device Recall · May 23, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665Medline 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.
- Class II
Medical Device Recall · May 23, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148BMedline 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.
- Class II
Medical Device Recall · May 23, 2025
MEDLINE INDUSTRIES, LP - Northfield
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)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.
- Class II
Medical Device Recall · May 22, 2025
Siemens Healthcare Diagnostics, Inc.
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
- Class II
Medical Device Recall · May 22, 2025
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.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 contained a left nail.
- Class I
Medical Device Recall · May 22, 2025
Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator, 8CM, Box of 5.Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- Class I
Medical Device Recall · May 22, 2025
Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator 8CM, Box of 1.Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- Class II
Medical Device Recall · May 22, 2025
Jewel Precision Sheet Metal & Machining Co, Inc.
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
- Class II
Medical Device Recall · May 22, 2025
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Cardiology Hemodynamics SoftwareDue to complaints, software update may cause software to unexpectedly shutdown.
- Class II
Medical Device Recall · May 22, 2025
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.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 contained a left nail.
- Class II
Medical Device Recall · May 22, 2025
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
- Class II
Medical Device Recall · May 22, 2025
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Cardiology Hemo SoftwareDue to complaints, software update may cause software to unexpectedly shutdown.
- Class II
Medical Device Recall · May 22, 2025
IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
- Class I
Medical Device Recall · May 22, 2025
Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator, 15 CM, Box of 5.Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- Class II
Medical Device Recall · May 21, 2025
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnlyDue to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
- Class II
Medical Device Recall · May 21, 2025
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLYDue to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
- Class II
Medical Device Recall · May 21, 2025
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnlyDue to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
- Class II
Medical Device Recall · May 21, 2025
LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous brDue to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
- Class II
Medical Device Recall · May 21, 2025
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnlyDue to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
- Class II
Medical Device Recall · May 21, 2025
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnlyDue to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.