Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-03-14FDA-DeviceBausch & Lomb Inc IrbClass IILASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7529, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- 2018-03-14FDA-DeviceBausch & Lomb Inc IrbClass IILASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- 2018-03-14FDA-DeviceBausch & Lomb Inc IrbClass IILASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- 2018-03-14FDA-DeviceBausch & Lomb Inc IrbClass IILASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75 (6/BOX), REF/PRODUCT CODE E7527, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- 2018-03-14FDA-DeviceBausch & Lomb Inc IrbClass IILASEREDGE Knives, 22.5 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7522, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- 2018-03-14FDA-DeviceBausch & Lomb Inc IrbClass IILASEREDGE Knives, 20 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7520, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- 2018-03-14FDA-DeviceBausch & Lomb Inc IrbClass IILASEREDGE Knives, 19 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7519, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- 2018-03-14FDA-DeviceBausch & Lomb Inc IrbClass IILASEREDGE Knives, 15 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7515T, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- 2018-03-14FDA-DeviceBausch & Lomb Inc IrbClass IILASEREDGE Knives, 15 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7515, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- 2018-03-14FDA-DeviceBausch & Lomb Inc IrbClass IILASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- 2018-03-14FDA-DeviceBausch & Lomb Inc IrbClass IILASEREDGE Knives, CRESCENT BLADE BEVELED DN (6/BOX), REF/PRODUCT CODE E7510D, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- 2018-03-14FDA-DeviceBausch & Lomb Inc IrbClass IILASEREDGE Knives, CRESCENT BLADE ANGLED TIP BEVEL UP (6/BOX), REF/PRODUCT CODE E7510AT, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- 2018-03-14FDA-DeviceBausch & Lomb Inc IrbClass IILASEREDGE Knives, CRESCENT BLADE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- 2018-03-14FDA-DeviceBausch & Lomb Inc IrbClass IILASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- 2018-03-14FDA-DevicePhilips Electronics North America CorporationClass IIPhilips Network Firewall (Cisco ASA 5506), Model # 867098
Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic may have a defective component, which may result in loss of connection to the Information Center iX. The defect involves the clock signal component within the firewall. This component has a high probability of failing in appliances that have been running for greater than 18 months. If the clock signal component were to fail, the firewall will stop functioning, will not boot, and is not recoverable. This failure will result in loss of communication between devices that are separated by the firewall, which may cause the Information Center to reboot.
- 2018-03-14FDA-DeviceDePuy Orthopaedics, Inc.Class IIConcorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Potential for Intra-operative breakage of driver tips
- 2018-03-14FDA-DeviceDePuy Orthopaedics, Inc.Class IIConcorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Potential for Intra-operative breakage of driver tips
- 2018-03-14FDA-DeviceMindray DS USA, Inc. dba Mindray North AmericaClass IIA-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.
A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.
- 2018-03-14FDA-DeviceMindray DS USA, Inc. dba Mindray North AmericaClass IIA-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.
A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.
- 2018-03-14FDA-DeviceToshiba American Medical Systems IncClass IIINFX-8000H Fluoroscopic X-Ray Systems
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
- 2018-03-14FDA-DeviceToshiba American Medical Systems IncClass IIINFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
- 2018-03-14FDA-DeviceToshiba American Medical Systems IncClass IIINFX-8000C Fluoroscopic X-Ray Systems
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
- 2018-03-14FDA-DeviceToshiba American Medical Systems IncClass IIINFX-8000F Fluoroscopic X-Ray Systems
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
- 2018-03-14FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIIQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.
- 2018-03-14FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIBrilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the CT simulation Exam Card; Software errors that may result in Tumor LOC allowing POI (Point of Interest) locking when a non-isocenter slice is displayed; Software errors that may result in partial set of images or inability to generate CT images.
- 2018-03-14FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIBrilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the CT simulation Exam Card; Software errors that may result in Tumor LOC allowing POI (Point of Interest) locking when a non-isocenter slice is displayed; Software errors that may result in partial set of images or inability to generate CT images.
- 2018-03-14FDA-DeviceStryker CorporationClass IIACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries.
- 2018-03-14FDA-DeviceStryker CorporationClass IISTRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
- 2018-03-14FDA-DeviceStryker CorporationClass IISTRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
- 2018-03-14FDA-DeviceStryker CorporationClass IIStrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
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