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.

2018-02-21FDA-DeviceArrow International IncClass II
ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.
2018-02-21FDA-DeviceConforMIS, Inc.Class II
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.
Implant kit mislabeled
2018-02-21FDA-Device3M Company - Health Care BusinessClass II
3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.
Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use.
2018-02-21FDA-Device3M Company - Health Care BusinessClass II
3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.
Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use.
2018-02-21FDA-DeviceOrthoPediatrics CorpClass II
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
2018-02-21FDA-DeviceZimmer Biomet, Inc.Class II
Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.
Potential for the Persona Partial Knee Impactor Pad to fracture.
2018-02-21FDA-DeviceHologic, IncClass II
Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test samples with random access or batch managed; can perform multiple assays on the same patient sample with up to 4 different assays simultaneously.
The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.
2018-02-21FDA-DeviceDePuy Orthopaedics, Inc.Class II
CORAIL HIGH OFFSET STEM Collarless SIZE 14
Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).
2018-02-21FDA-DeviceDePuy Orthopaedics, Inc.Class II
CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).
2018-02-21FDA-DeviceCepheidClass II
Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test.
Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended use specimen types. Investigation of the issue also revealed an occasional probability of false negative results which remains consistent with package insert claims.
2018-02-21FDA-DeviceAesculap Implant Systems LLCClass II
NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.
The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and possible revision surgery.
2018-02-21FDA-DeviceAvid Medical, Inc.Class II
AVID Medical QA Pack AV10654-10
The swab stick collection device provided in a convenience kit expires prior to the kit expiration date.
2018-02-21FDA-DeviceGE Medical Systems China Co., Ltd.Class II
Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
2018-02-21FDA-DeviceGE Medical Systems China Co., Ltd.Class II
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
2018-02-21FDA-DeviceLITTLE RAPIDS CORPORATIONClass II
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
The secondary supplier provided material was within specification but did not meet our design needs compared to the primary manufacturer. The product is designed for patient transfer, not lifting. However, we recognize that the product may be utilized outside of its intended design scope, and lifting may occur. Lifting could lead tearing of the equipment cover and the potential for patient falling through.
2018-02-21FDA-DeviceSmiths Medical ASD, Inc.Class II
Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
2018-02-21FDA-DeviceB. Braun Medical, Inc.Class II
Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
2018-02-21FDA-DeviceB. Braun Medical, Inc.Class II
Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
2018-02-21FDA-DeviceB. Braun Medical, Inc.Class II
Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
2018-02-21FDA-DeviceB. Braun Medical, Inc.Class II
Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
2018-02-21FDA-DeviceB. Braun Medical, Inc.Class II
PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
2018-02-21FDA-DeviceB. Braun Medical, Inc.Class II
Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
2018-02-21FDA-DeviceB. Braun Medical, Inc.Class II
Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552024. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
2018-02-21FDA-DeviceB. Braun Medical, Inc.Class II
Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
2018-02-21FDA-DeviceB. Braun Medical, Inc.Class II
Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
2018-02-21FDA-DeviceB. Braun Medical, Inc.Class II
Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
2018-02-21FDA-DeviceMedtronic Sofamor Danek USA IncClass II
Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.
2018-02-21FDA-DeviceC.R. Bard, Inc.Class II
BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.
2018-02-21FDA-DeviceKalila MedicalClass II
Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process.
2018-02-21FDA-DeviceKalila MedicalClass II
Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process.

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