Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 3,551–3,600 of 8,689
- Class III
Medical Device Recall · July 3, 2025
eL18-4 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
S5-2 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
L12-4 Lumify Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
S7-3t Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
C9-4v Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
S8-3t Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
VL13-5 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
L12-5 38mm Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
D5cwc Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
L12-3 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
L10-4LAP Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
C10-4ec Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
X6-1 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
mL26-8 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
S4-1 Lumify Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
OMNI II TEE Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
C6-3 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class II
Medical Device Recall · July 2, 2025
GE HealthCare OEC 9900 Elite C-arm Systems.GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
- Class II
Medical Device Recall · July 2, 2025
Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
- Class II
Medical Device Recall · July 2, 2025
GE HealthCare OEC 9800.GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
- Class II
Medical Device Recall · July 2, 2025
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
- Class II
Medical Device Recall · July 1, 2025
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: RobDue to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
- Class II
Medical Device Recall · July 1, 2025
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULDevice used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.
- Class II
Medical Device Recall · July 1, 2025
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: RobDue to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
- Class II
Medical Device Recall · July 1, 2025
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description:Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
- Class II
Medical Device Recall · July 1, 2025
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 ProductDue to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
- Class II
Medical Device Recall · June 30, 2025
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Laser light show projectors manufactured by BLS, Model PURE 5000/10000.The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.
- Class II
Medical Device Recall · June 30, 2025
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Upgrade to MR 7700 Model Number (REF): 782130;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POCannulated fenestrated polyaxial screws may be incorrectly labeled
- Class II
Medical Device Recall · June 30, 2025
Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.
- Class II
Medical Device Recall · June 30, 2025
Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028.Potential for temporary loss of imaging (X-ray) functionality due to software issue.
- Class II
Medical Device Recall · June 30, 2025
Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Intera 3.0T Quasar Dual Model Number (REF): 781150;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
SmartPath to dStream for 3.0T Model Number (REF): 782145;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.
- Class II
Medical Device Recall · June 30, 2025
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POCannulated fenestrated polyaxial screws may be incorrectly labeled
- Class II
Medical Device Recall · June 30, 2025
Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class I
Medical Device Recall · June 30, 2025
DreamStation Auto. Non-Continuous Ventilator.Devices may possess a programming error resulting in an incorrect device configuration.
- Class II
Medical Device Recall · June 30, 2025
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.