Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-09-05FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIRAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels.
- 2018-09-05FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIRAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels.
- 2018-09-05FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIRAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels.
- 2018-09-05FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIRAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit, neonatal total bilirubin and full CO-oximetry from a single sample.
Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels.
- 2018-09-05FDA-DeviceStanbio Laboratory, LPClass IIStanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.
- 2018-09-05FDA-DeviceMako Surgical CorporationClass IIStryker Mako Vizadisc Hip Procedure Tracking Kit
Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
- 2018-09-05FDA-DeviceMako Surgical CorporationClass IIStryker Mako Vizadisc Knee Procedure Tracking Kit
Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
- 2018-09-05FDA-DeviceTecan US, Inc.Class IICortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.
Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST cortisol standard.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIAXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIAXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIAXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIAXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIAXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIAXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIQUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIQUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIQUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIQUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIQUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIQUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIQUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIQUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIQUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIQUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIQUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceStryker Leibinger GmbH & Co. KGClass IIQUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- 2018-09-05FDA-DeviceBiosense Webster, Inc.Class IWaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting in increased retraction force and difficulty or failure to recapture the device.
- 2018-08-29FDA-DeviceEuro Diagnostica ABClass IIIis a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
- 2018-08-29FDA-DeviceEuro Diagnostica ABClass IIIis a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders.
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
- 2018-08-29FDA-DeviceEuro Diagnostica ABClass IIIis a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
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