Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IICOBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceDraeger Medical Systems, Inc.Class IIInfinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia.
- 2024-07-03FDA-DeviceSiemens Medical Solutions USA, IncClass IIZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as for use in outpatient departments Material Number: 5901900
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- 2024-07-03FDA-DeviceSiemens Medical Solutions USA, IncClass IIMULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 475525
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- 2024-07-03FDA-DeviceSiemens Medical Solutions USA, IncClass IIMULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number:475517
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- 2024-07-03FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- 2024-07-03FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: MD39543
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- 2024-07-03FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395431
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- 2024-07-03FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395381
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- 2024-07-03FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395415
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- 2024-07-03FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- 2024-07-03FDA-DeviceBiomet, Inc.Class IIRingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
- 2024-07-03FDA-DeviceDental EZ Group Star Dental DivisionClass IITitan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.
Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
- 2024-07-03FDA-DeviceDental EZ Group Star Dental DivisionClass IITitan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.
Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
- 2024-07-03FDA-DeviceMaquet Cardiovascular, LLCClass IIThe VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is use
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
- 2024-07-03FDA-DeviceMaquet Cardiovascular, LLCClass IIThe VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. Th
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
- 2024-07-03FDA-DeviceRoche Diabetes Care, Inc.Class IIAccu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. Product REF Number: 08453071001
The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates. This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development of microvascular (i.e., retinopathy, neuropathy, nephropathy) and/or macrovascular (i.e., myocardial infarction, ischemic stroke) complications of diabetes and could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies) in pregnant women. This issue was identified by three initial consumer complaints, with reports that the meters were presenting the incorrect unit of measure.
- 2024-07-03FDA-DeviceSIGHT DIAGNOSTICS LTDClass IISight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification.
- 2024-07-03FDA-DeviceGE Healthcare Finland OyClass IICARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-017, 5) 2078633-028, 6) 2095802-001-54069330, 7) 2095802-001-554922, 8) 2095802-001-554923, 9) 2095802-001-554924, 10) 2095802-001-554925, 11) 2095802-001-554926, 12) 2095802-001-554927, 13) 2095802-001-554928, 14) 2095802-001-555120, 15) 2095802-001-556223, 16) 2095802-001-557346, 17) 2095802-001-558678, 18) 2095802-001-558707, 19) 2095802-001-559208, 20) 20
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
- 2024-07-03FDA-DeviceGE Healthcare Finland OyClass IICARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-01023151, 5) 2095801-001-01023152, 6) 2095801-001-01032962, 7) 2095801-001-01033915, 8) 2095801-001-01034302, 9) 2095801-001-01034399, 10) 2095801-001-01034528, 11) 2095801-001-01034573, 12) 2095801-001-01035087, 13) 2095801-001-01036384, 14) 2095801-001-01037712, 15) 2095801-001-01038022, 16) 2095801-001-01038593, 17) 2095801-001-01041035
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
- 2024-07-03FDA-DeviceGE Healthcare Finland OyClass IICARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 5514418-01088182, i) 5514418-01108442, j) 5514418-01118673, k) 5514418-01120764, l) 5514418-01166521, m) 5514418-01180241, n) 5514418-01181177, o) 5514418-01183037, p) 5514418-01184556, q) 5514418-01184557, r) 5514418-01185805, s) 5514418-01186277, t) 5514418-01187473, u) 5514418-01188453
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
- 2024-07-03FDA-DeviceGE Healthcare Finland OyClass IICARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
- 2024-07-03FDA-DeviceGE Healthcare Finland OyClass IICARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f) 5865770-01054721; g) 5865770-01054740; h) 5865770-01055202; i) 5865770-01055204; j) 5865770-01055270; k) 5865770-01055317; l) 5865770-01055796; m) 5865770-01058501; n) 5865770-01058596; o) 5865770-01058597; p) 5865770-01059641; q) 5865770-01062146; r) 5865770-01065501; s) 5865770-01065702; t) 5865770-01065703; u) 5865770-01065739; v) 5865
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
- 2024-07-03FDA-DeviceIntegra LifeSciences Corp.Class IICUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue Catalog Number: C2600* *Note: you may see C2600P or C2600SRL on labeling. This notice is applicable for those SKUs as well
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
- 2024-07-03FDA-DevicePhilips North America LlcClass ISENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
Potential for coils to heat up and harm patients (burn).
- 2024-07-03FDA-DevicePhilips North America LlcClass ISENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.
Potential for coils to heat up and harm patients (burn).
- 2024-07-03FDA-DevicePhilips North America LlcClass ISENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
Potential for coils to heat up and harm patients (burn).
- 2024-07-03FDA-DeviceInspire Medical Systems Inc.Class IInspire Model 3028, IV Implantable Pulse Generator
There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,
- 2024-07-03FDA-DeviceBaxter Healthcare CorporationClass ILife2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery from charging.
- 2024-06-26FDA-DeviceBeaver Visitec International, Inc.Class IIXstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
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