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.
- 2018-06-20FDA-DeviceSun Med, LLCClass IIMEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 2018-06-20FDA-DeviceSun Med, LLCClass IIMEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1116F
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 2018-06-20FDA-DeviceSun Med, LLCClass IIMEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 2018-06-20FDA-DeviceSun Med, LLCClass IISTAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- 2018-06-20FDA-DevicePhilips Electronics North America CorporationClass IIIntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146
Five warning statements are missing from the instructions for use.
- 2018-06-20FDA-DevicePhilips Electronics North America CorporationClass IIIntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
Five warning statements are missing from the instructions for use.
- 2018-06-20FDA-DevicePhilips Electronics North America CorporationClass IIIntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
Five warning statements are missing from the instructions for use.
- 2018-06-20FDA-DevicePhilips Electronics North America CorporationClass IIIntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
Five warning statements are missing from the instructions for use.
- 2018-06-20FDA-DeviceAlere San Diego Inc. DBA Immunalysis CorporationClass IIIlmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Tandem Mass Spectrometry, must be used to obtain a confirmed analytical result.
The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce values below 100 ng/mL when run on validated clinical chemistry analyzers, which is below the 100 ng/mL cutoff of the EDDP Specific Urine Enzyme Immunoassay with which this control is utilized.
- 2018-06-20FDA-DeviceIon Beam Applications S.A.Class IIProteus ONE and Proteus Plus
IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.
- 2018-06-20FDA-DeviceIon Beam Applications S.A.Class II12C
IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.
- 2018-06-20FDA-DeviceThermo FisherClass IIremel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).
Product may fail performance testing for S aureus ATCC 43300.
- 2018-06-20FDA-DeviceRoche Diagnostics CorporationClass IIcobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.
The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
- 2018-06-20FDA-DeviceShimadzu Medical SystemsClass IISonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.
When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.
- 2018-06-20FDA-DeviceZeiss, Carl IncClass IICell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research.
In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.
- 2018-06-13FDA-DeviceOrthofix, IncClass IIY-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IIT-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IITN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); c) Large (002-F-01030)
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IIStraight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001)
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IIMTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IIL-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IILapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000L); b) Small/0MM Step/Right (002-C-01000R); c) Large/0MM Step/Left (002-C-02000L); d) Large/0MM Step/Right (002-C-02000R); e) Small/2MM Step/Left (002-C-01002L); f) Small/2MM Step/Right (002-C-01002R); g) Large/2MM Step/Left (002-C-02002L); h) Large/2MM Step/Right (002-C-02002R)
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IIH-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001); b) 15MM Spacer (003-H-15001); 20MM Spacer (003-H-20001); 25MM Spacer (003-H-25001); 30 MM (003-H-30001)
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IIEvans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006); b) 8MM Spacer (022-H-00008); c) 10MM Spacer (002-H-00010); d) 12MM Spacer (002-H-00012)
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IICC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030)
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IIBox Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001); b) 22MM (003-F-22001); c) 30MM (003-F-30001)
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IILocking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014) d) D 3.2MM X 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM (002-E-32020) g) D 3.2MM X 22MM (002-E-32022) h) D 3.2MM X 24MM (002-E-32024) i) D 3.2MM X 26MM (002-E-32026) j) D 3.2MM X 28MM (002-E-32028) k) D 3.2MM X 30MM (002-E-32030) l) D 3.2MM X 32MM (002-E-32032) m) D 3.2MM X 34MM (
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IINon-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-32014) d) D 3.2MM X 16MM (002-D-32016) e) D 3.2MM X 18MM (002-D-32018) f) D 3.2MM X 20MM (002-D-32020) g) D 3.2MM X 22MM (002-D-32022) h) D 3.2MM X 24MM (002-D-32024) i) D 3.2MM X 26MM (002-D-32026) j) D 3.2MM X 28MM (002-D-32028) k) D 3.2MM X 30MM (002-D-32030) l) D 3.2MM X 32MM (002-D-32032) m) D 3.2MM X 34M
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IILocking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (002-E-27010); c) D 2.7MM X 12MM (002-E-27012); d) D 2.7MM X 14MM (002-E-27014); e) D 2.7MM X 16MM (002-E-27016); f) D 2.7MM X 18MM (002-E-27018); g) D 2.7MM X 20MM (002-E-27020); h) D 2.7MM X 22MM (002-E-27022); i) D 2.7MM X 24MM (002-E-27024); j) D 2.7MM X 26MM (002-E-27026); k) D 2.7MM X 28MM (002-E-27028); l) D 2.7MM X 30MM (002-E-27030); m) D 2.7
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IINon-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008); b) D 2.7MM X 10MM (002-D-27010); c) D 2.7MM X 12MM (002-D-27012); d) D 2.7MM X 14MM (002-D-27014); e) D 2.7MM X 16MM (002-D-27016); f) D 2.7MM X 18MM (002-D-27018); g) D 2.7MM X 20MM (002-D-27020); h) D 2.7MM X 22MM (002-D-27022); i) D 2.7MM X 24MM (002-D-27024); j) D 2.7MM X 26MM (002-D-27026); k) D 2.7MM X 28MM (002-D-27028); l) D 2.7MM
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
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