Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 6,751–6,800 of 8,689
- Class II
Medical Device Recall · May 15, 2024
HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67FEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AAEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AGEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10LEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22VEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22UEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary andProduct labels state the incorrect expiration dates that extends beyond their true expiration date
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE-Procedure Kit Catalog Number: SMTK21CEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AFEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44SEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01ZEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
HAND PACK-Procedure Kit Catalog Number: WEHD16CEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AAEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AEEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10KEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE-Procedure Kit Catalog Number: SFTK54BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56XEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21EEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class III
Medical Device Recall · May 14, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of totaKit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them to use the expired calibrator which may bias the results. However, at this time the calibrator is within its use date and will function appropriately.
- Class II
Medical Device Recall · May 14, 2024
Greiner Bio-One North America, Inc.
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridgedThe firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment.
- Class II
Medical Device Recall · May 14, 2024
Applied Medical Technology Inc
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.Devices were labelled with the incorrect guidewire labelling.
- Class II
Medical Device Recall · May 14, 2024
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid.
- Class II
Medical Device Recall · May 13, 2024
BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1HM-1FM/ 169-102, MEDBANK MINI 1HH-3HM/ 169-103, MEMultiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with automated dispensing cabinet devices, so use may expose user to leakage currents that could cause varying degrees of harm from a minor shock to permanent impairment.
- Class II
Medical Device Recall · May 13, 2024
Aeos Robotic Digital Microscope, Product Code: PV010Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.
- Class II
Medical Device Recall · May 13, 2024
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification.
- Class II
Medical Device Recall · May 13, 2024
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia.
- Class II
Medical Device Recall · May 13, 2024
BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with automated dispensing cabinet devices, so use may expose user to leakage currents that could cause varying degrees of harm from a minor shock to permanent impairment.
- Class II
Medical Device Recall · May 13, 2024
Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powderFirm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating another size).
- Class II
Medical Device Recall · May 13, 2024
Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose controlThe reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates. This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development of microvascular (i.e., retinopathy, neuropathy, nephropathy) and/or macrovascular (i.e., myocardial infarction, ischemic stroke) complications of diabetes and could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies) in pregnant women. This issue was identified by three initial consumer complaints, with reports that the meters were presenting the incorrect unit of measure.
- Class II
Medical Device Recall · May 13, 2024
Young Dental Manufacturing I, LLC
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint CoarsePart number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
- Class II
Medical Device Recall · May 10, 2024
LEICA BIOSYSTEMS NUSSLOCH GMBH
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.
- Class II
Medical Device Recall · May 10, 2024
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are pIssue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Class II
Medical Device Recall · May 10, 2024
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.
- Class II
Medical Device Recall · May 10, 2024
Beaver Visitec International, Inc.
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
- Class II
Medical Device Recall · May 10, 2024
Canon Medical System, USA, INC.
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.
- Class II
Medical Device Recall · May 10, 2024
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359HIssue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Class II
Medical Device Recall · May 10, 2024
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
- Class II
Medical Device Recall · May 10, 2024
Stryker Sustainability Solutions
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx OnlyDiagnostic electrophysiology (EP) catheters do not meet testing requirements.
- Class II
Medical Device Recall · May 10, 2024
Beaver Visitec International, Inc.
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
- Class II
Medical Device Recall · May 10, 2024
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissueIssue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Class II
Medical Device Recall · May 10, 2024
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. TheIssue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Class II
Medical Device Recall · May 10, 2024
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT COIssue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Class II
Medical Device Recall · May 10, 2024
MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MIssue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Class II
Medical Device Recall · May 9, 2024
Remote Diagnostic Technologies Ltd.
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator ManualSimultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.
- Class II
Medical Device Recall · May 9, 2024
Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET,Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
- Class II
Medical Device Recall · May 9, 2024
First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.