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.

2019-04-03FDA-DevicePhilips North America, LLCClass II
URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and no
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
2019-04-03FDA-DevicePhilips North America, LLCClass II
MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
2019-04-03FDA-DevicePhilips North America, LLCClass II
Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtrac
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
2019-04-03FDA-DevicePhilips North America, LLCClass II
Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition cystography Cystoscopy, endopscopy Transurethral resection Percutaneous nephroscopy Urethrorenoscopy Percutaneous nephrolithotomy Serial angiography with image intensifier and DSI Tomography
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
2019-04-03FDA-DevicePhilips North America, LLCClass II
MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystem
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
2019-04-03FDA-DeviceBecton Dickinson & Co.Class II
BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from external software systems allowing for the aggregation, evaluation, dissemination of knowledge using all data, anywhere, anytime. Currently Release 2 of BD
BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
2019-04-03FDA-DeviceLW Scientific, Inc.Class II
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotors to spin other fluids in test tubes (15ml and 50ml), microtubes, and PCR strips
The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area.
2019-04-03FDA-DeviceLW Scientific, Inc.Class II
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotor to spin other fluids in test tubes (15ml)
The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area.
2019-04-03FDA-DeviceLW Scientific, Inc.Class II
LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes
The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area.
2019-04-03FDA-DeviceAvitus Orthopaedics, Inc.Class II
Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
Breach in the sterile barrier pouch may compromise sterility of the device.
2019-04-03FDA-DeviceAvitus Orthopaedics, Inc.Class II
Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
Breach in the sterile barrier pouch may compromise sterility of the device.
2019-04-03FDA-DeviceSmith & Nephew, Inc.Class II
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
2019-04-03FDA-DeviceSmith & Nephew, Inc.Class II
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
2019-04-03FDA-DeviceSmith & Nephew, Inc.Class II
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
2019-04-03FDA-DeviceSmith & Nephew, Inc.Class II
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
2019-04-03FDA-DeviceCOVIDIEN LLCClass II
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
2019-04-03FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass I
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.
2019-03-27FDA-DeviceFujifilm Medical Systems U.S.A., Inc.Class II
Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>
FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released.
2019-03-27FDA-DeviceShimadzu Medical Systems Usa ComClass II
SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).
In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle. However, for systems within a specified manufacture period, we have identified that even when letting go of the handle, the systems brakes are not applied. In this event, if the Operator releases the handle when the device is moving, the unit will continue to coast.
2019-03-27FDA-DeviceConvaTec, IncClass II
FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments, chips, cement, marrow and blood clots without blocking the suction device, using a combination of suctioning and filtering.
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
2019-03-27FDA-DeviceConvaTec, IncClass II
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted intermittently through the urethra and up to the bladder enabling urine to drain. They are designed for short-term, intermittent transient use only and are not intended to be left in situ (there is no bal
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
2019-03-27FDA-DeviceConvaTec, IncClass II
Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum to assist in the drainage of gastric contents, decompression of the stomach or duodenum, or for obtaining a specimen of gastric contents. The device is intended to administer medication or fluids,
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
2019-03-27FDA-DeviceConvaTec, IncClass II
Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forceps may be used in conditions where it is difficult to grasp small objects by hand and increased precise function is required. Applications in which sterile forceps are commonly used include wound care: e.g. gripping, debr
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
2019-03-27FDA-DeviceAgfa N.V.Class III
PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities.
Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities
2019-03-27FDA-DeviceACell, IncClass II
Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair,
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
2019-03-27FDA-DeviceACell, IncClass II
Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair,
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
2019-03-27FDA-DeviceCTL Medical CorporationClass II
CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.
2019-03-27FDA-DeviceCTL Medical CorporationClass II
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.
2019-03-27FDA-DeviceSmith & Nephew, Inc.Class II
smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
2019-03-27FDA-DeviceSmith & Nephew, Inc.Class II
smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"

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