The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Vanguard XP Tibial Tray 87 mm Item # 195254
Zimmer Biomet
Class I - Dangerous
The locking bar not fully engaging
Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
Teleflex Medical
Class I - Dangerous
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.
Class I - Dangerous
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Class I - Dangerous
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
XP-XP Tibial Tray - Interlok 87 mm Item # 195760
Zimmer Biomet
Class I - Dangerous
The locking bar not fully engaging
XP-CR Tibial Tray - Interlok 67mm Item # 195271
Zimmer Biomet
Class I - Dangerous
The locking bar not fully engaging
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 being skipped for the addition of the TMB substrate. Well H6 will generate a negative result regardless of whether the patient was negative or positive for that antibody. This could result in a potential false negative result for that assay for any patients tested in well H6.
XP-CR Tibial Tray - Interlok 69mm Item # 195272
Zimmer Biomet
Class I - Dangerous
The locking bar not fully engaging
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.
Vanguard XP Tibial Tray 83 mm Item # 195253
Zimmer Biomet
Class I - Dangerous
The locking bar not fully engaging
Class I - Dangerous
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
Aesculap Implant Systems
Class I - Dangerous
possibility of the sterility batch being insufficiently sterilized
XP-XP Tibial Tray - Interlok 91mm Item # 195761
Zimmer Biomet
Class I - Dangerous
The locking bar not fully engaging
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
OMNIlife science
Class I - Dangerous
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Roche Diagnostics Operations
Class I - Dangerous
Quality issue with high pressure solenoid valves may cause inaccurate results.
CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186
B. Braun Medical
Class I - Dangerous
The filter capacity is not achieved due to damage of the filter membrane.