Medical Device Recalls

7,979 medical device recalls from federal enforcement feeds.

Showing 4,801–4,850 of 7,979

• Medical Device Recall · September 27, 2024

  Westmed, Inc.

  1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, co

  Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.

  Class II

• Medical Device Recall · September 27, 2024

  Accriva Diagnostics, Inc.

  AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.

  Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.

  Class II

• Medical Device Recall · September 26, 2024

  King Systems Corp. dba Ambu, Inc.

  KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431

  Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

  Class II

• Medical Device Recall · September 26, 2024

  King Systems Corp. dba Ambu, Inc.

  AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420

  Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

  Class II

• Medical Device Recall · September 26, 2024

  Integra LifeSciences Corp.

  Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694

  Out of specification endotoxin levels.

  Class II

• Medical Device Recall · September 26, 2024

  King Systems Corp. dba Ambu, Inc.

  KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432

  Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

  Class II

• Medical Device Recall · September 26, 2024

  King Systems Corp. dba Ambu, Inc.

  KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430

  Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

  Class II

• Medical Device Recall · September 26, 2024

  King Systems Corp. dba Ambu, Inc.

  KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225

  Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

  Class II

• Medical Device Recall · September 26, 2024

  King Systems Corp. dba Ambu, Inc.

  KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422

  Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

  Class II

• Medical Device Recall · September 26, 2024

  King Systems Corp. dba Ambu, Inc.

  KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421

  Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

  Class II

• Medical Device Recall · September 26, 2024

  King Systems Corp. dba Ambu, Inc.

  KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325

  Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

  Class II

• Medical Device Recall · September 25, 2024

  Biocare Medical, LLC

  intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPR

  Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.

  Class II

• Medical Device Recall · September 25, 2024

  Ethicon, Inc.

  Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H

  Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.

  Class II

• Medical Device Recall · September 25, 2024

  Cardinal Health 200, LLC

  Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777

  Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.

  Class I

• Medical Device Recall · September 25, 2024

  Elekta Instrument AB

  Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotacti

  Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.

  Class I

• Medical Device Recall · September 24, 2024

  Orthofix Srl

  REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile

  Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Medtronic Neuromodulation

  Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.

  A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex Arterial Kit 1/EA, Product Code REF MX7827

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar Single ICP Set 1/EA, Product Code REF MX20897

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  West Pharmaceutical Services AZ, Inc.

  Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product Description: The Vial2Bag Advanced 20mm

  Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar Disposable Transducer 1/EA, Product Code REF MX950

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Olympus Corporation of the Americas

  Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images f

  Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the replacement of the device. This could potentially result in a prolonged procedure and/or require additional medical intervention

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Siemens Healthcare Diagnostics Inc

  epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

  Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. One customer complaint has been associated with this issue. No adverse events have been reported. All affected lots have recently expired before the issuance of the recall.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 24, 2024

  Smiths Medical ASD, Inc.

  medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1

  Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

  Class II

• Medical Device Recall · September 23, 2024

  Pro-Dex Inc

  KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000

  The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.

  Class II

• Medical Device Recall · September 22, 2024

  Onkos Surgical, Inc.

  ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

  Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

  Class II

• Medical Device Recall · September 20, 2024

  AVID Medical, Inc.

  Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05

  Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

  Class II

• Medical Device Recall · September 20, 2024

  AVID Medical, Inc.

  Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02

  Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

  Class II

• Medical Device Recall · September 20, 2024

  AVID Medical, Inc.

  Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08

  Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

  Class II

• Medical Device Recall · September 20, 2024

  AVID Medical, Inc.

  Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19

  Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

  Class II