Medical Device Recalls
RSS ↗7,979 medical device recalls from federal enforcement feeds.
Showing 7,901–7,950 of 7,979
- Class II
Medical Device Recall · August 29, 2023
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modulesUnintended movement of bed wheels
- Class II
Medical Device Recall · August 29, 2023
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modulesUnintended movement of bed wheels
- Class II
Medical Device Recall · August 29, 2023
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-ThIncorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
- Class II
Medical Device Recall · August 25, 2023
Beaver Visitec International, Inc.
Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade.
- Class II
Medical Device Recall · August 25, 2023
Detector H. Pylori, Catalog Number IHP-30Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive, false negative, or invalid results.
- Class II
Medical Device Recall · August 10, 2023
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)A software update corrected an 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 II
Medical Device Recall · August 8, 2023
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210Centered glenosphere box may contain an eccentric glenosphere.
- Class II
Medical Device Recall · July 20, 2023
Philips Medical Systems Nederland B.V.
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
- Class II
Medical Device Recall · July 19, 2023
NOxBOXi Nitric Oxide Delivery SystemReplacement of the internal Sample Pump due to high failure rates.
- Class II
Medical Device Recall · July 14, 2023
L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-SterileWrong product coloring. The paddle clips should be blank, but they are colored blue.
- Class II
Medical Device Recall · July 14, 2023
L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, SterileWrong product coloring. The paddle clips should be blank, but they are colored blue.
- Class II
Medical Device Recall · June 28, 2023
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throatThere is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).
- Class II
Medical Device Recall · June 28, 2023
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgeryThere is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
- Class II
Medical Device Recall · June 28, 2023
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgeryThere is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
- Class II
Medical Device Recall · June 14, 2023
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062;Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.
- Class II
Medical Device Recall · June 9, 2023
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292Sterility of Ultrasound gel can not be guaranteed.
- Class I
Medical Device Recall · June 6, 2023
GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 20Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
- Class I
Medical Device Recall · June 6, 2023
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
- Class II
Medical Device Recall · June 6, 2023
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.
- Class II
Medical Device Recall · May 31, 2023
MICRO-X Rover Mobile X-ray System, # MXU-RV35Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
- Class II
Medical Device Recall · May 30, 2023
ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566Medical device components were marketed without FDA clearance and without FDA approval
- Class II
Medical Device Recall · May 30, 2023
ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266Medical device components were marketed without FDA clearance
- Class II
Medical Device Recall · May 30, 2023
Alinity ci-series System Control Module, REF: 03R70-01There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.
- Class II
Medical Device Recall · May 30, 2023
Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052Medical device components were marketed without FDA clearance
- Class II
Medical Device Recall · May 24, 2023
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnosticComplaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
- Class II
Medical Device Recall · May 10, 2023
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
- Class II
Medical Device Recall · April 19, 2023
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address will be assigned to the MX40. The PIC iX will not recognize the new IP address after reconnecting and therefore the expecting settings sync fails.
- Class II
Medical Device Recall · April 5, 2023
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server connection failed," not listing other area devices where unavailable item(s) may be found, which may lead to delayed therapy.
- Class I
Medical Device Recall · March 28, 2023
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
- Class II
Medical Device Recall · March 14, 2023
Advanced Research Medical, LLC
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc diseasePotential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
- Class II
Medical Device Recall · March 13, 2023
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
- Class II
Medical Device Recall · February 15, 2023
FoundationOne Companion Diagnostic (F1CDx)An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
- Class II
Medical Device Recall · February 14, 2023
BD Pyxis Med 4000 Auxiliary (AUX), REF 314Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
- Class II
Medical Device Recall · February 14, 2023
BD Pyxis MedStation 4000 Main, REF 303Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
- Class II
Medical Device Recall · February 14, 2023
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are inteDue to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.
- Class II
Medical Device Recall · February 14, 2023
BD Pyxis MedStation ES AUX, REF 324Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
- Class II
Medical Device Recall · February 14, 2023
BD Pyxis Med ES Auxiliary (AUX), REF 343Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
- Class II
Medical Device Recall · February 14, 2023
BD Pyxis MedStation ES (Med ES Main), REF 323Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
- Class II
Medical Device Recall · February 14, 2023
BD Pyxis MedStation 4000 AUX, REF 306Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
- Class II
Medical Device Recall · February 9, 2023
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating SystemIf using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.
- Class II
Medical Device Recall · February 2, 2023
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
- Class III
Medical Device Recall · January 20, 2023
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
- Class III
Medical Device Recall · January 20, 2023
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
- Class III
Medical Device Recall · January 20, 2023
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
- Class III
Medical Device Recall · January 20, 2023
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
- Class III
Medical Device Recall · January 20, 2023
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
- Class II
Medical Device Recall · January 18, 2023
IntelliVue G7m Anesthesia Gas Module, Product Number 866173The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a technical, INOP (inoperable) alarm. The pump may fail prematurely when there is friction caused by an abrasion. This recall is for an IMPORTANT PRODUCT NOTICE dated 1/18/23.
- Class II
Medical Device Recall · December 23, 2022
Philips Healthcare (Suzhou) Co., Ltd.
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.
- Class II
Medical Device Recall · November 8, 2022
FoundationOne CDx (F1CDx), RAL-0003 version 31.0Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
- Class II
Medical Device Recall · November 8, 2022
FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.