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.

2019-06-19FDA-DeviceGE Healthcare, LLCClass II
Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
2019-06-19FDA-DeviceGE Healthcare, LLCClass II
Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
2019-06-19FDA-DeviceGE Healthcare, LLCClass II
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
2019-06-19FDA-DeviceGE Healthcare, LLCClass II
Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation, easy patient positioning, intuitive operator control and minimal system maintenance.
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
2019-06-19FDA-DeviceGE Healthcare, LLCClass II
Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system.
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
2019-06-19FDA-DeviceEdwards Lifesciences, LLCClass I
IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.
Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative strategy would need to change, including placement of an external cross-clamp, conversion to an open procedure, or performing the procedure under fibrillation.
2019-06-12FDA-DeviceBio-Rad Laboratories, IncClass II
MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
2019-06-12FDA-DeviceBio-Rad Laboratories, IncClass II
MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
2019-06-12FDA-DeviceZimmer Biomet, Inc.Class II
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Small
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
2019-06-12FDA-DeviceZimmer Biomet, Inc.Class II
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421060 Phase 3 Femoral Drill Guide Extra Small
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
2019-06-12FDA-DeviceZimmer Biomet, Inc.Class II
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420324Phase 3 Femoral Drill Guide Extra Large
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
2019-06-12FDA-DeviceZimmer Biomet, Inc.Class II
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420323 Phase 3 Femoral Drill Guide Large
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
2019-06-12FDA-DeviceZimmer Biomet, Inc.Class II
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
2019-06-12FDA-DeviceZimmer Biomet, Inc.Class II
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
2019-06-12FDA-DeviceZimmer Biomet, Inc.Class II
Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to per
Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
2019-06-12FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass II
GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.
User may suffer an electric shock when coming in contact with the exposed electronic components
2019-06-12FDA-DeviceSmiths Medical ASD Inc.Class II
Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.
Incorrect needle length and gage.
2019-06-12FDA-DeviceSmiths Medical ASD Inc.Class II
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.
Packaged with an incorrect size inner cannula.
2019-06-12FDA-DeviceMicrobiologics IncClass II
Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.
Product with incorrect shelf life.
2019-06-12FDA-DeviceMicrobiologics IncClass II
Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.
Product with incorrect shelf life.
2019-06-12FDA-DeviceLeica Microsystems, Inc.Class II
Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
The current labelling does not include any specific warning about usage of flammable freezing sprays. Such flammable freezing sprays can potentially ignite and can cause serious injuries.
2019-06-12FDA-DeviceStryker CorporationClass II
Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
The heated tube sets were consistently leaking and detaching from the cassette.
2019-06-12FDA-DeviceStryker CorporationClass II
Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
The heated tube sets were consistently leaking and detaching from the cassette.
2019-06-12FDA-DeviceStryker CorporationClass II
Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
The heated tube sets were consistently leaking and detaching from the cassette.
2019-06-12FDA-DeviceCook Inc.Class II
Thoracentesis Set, RPN C-THS-850, Order # G03286
Affected products may have been manufactured with the catheter distal end hole too small
2019-06-12FDA-DeviceCook Inc.Class II
Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030
Affected products may have been manufactured with the catheter distal end hole too small
2019-06-12FDA-DeviceCook Inc.Class II
Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284
Affected products may have been manufactured with the catheter distal end hole too small
2019-06-12FDA-DeviceCook Inc.Class II
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
Affected products may have been manufactured with the catheter distal end hole too small
2019-06-12FDA-DeviceKerr/Pentron, DBA Kerr Corporation and Pentron ClinicalClass II
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
2019-06-12FDA-DeviceCenturion Medical Products CorporationClass II
Sterile Nail Nipper, Barrel Spring (I68400), Sterile
Compromised seal on the sterile barrier pouch.

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