Class I - Dangerous
Complaints that the ratchet teeth of the tube are not latching onto the rod.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class I - Dangerous
Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.
Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole
Valeant Pharmaceuticals North America
Class I - Dangerous
SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.
A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list. At the stage where the order is signed, the medication displayed may be incorrect.
AMS 4674 Custom Pack. For use in a general clinical procedure.
Windstone Medical Packaging
Class I - Dangerous
AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Monitor Ceiling Suspension system may fall
Monitor Ceiling Suspension system may fall
Monitor Ceiling Suspension system may fall
Class I - Dangerous
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Monitor Ceiling Suspension system may fall
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
Monitor Ceiling Suspension system may fall
Class I - Dangerous
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Ormco/Sybronendo
Class I - Dangerous
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
Philips Medical Systems
Class I - Dangerous
The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
Class I - Dangerous
Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.
Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
Philips Medical Systems
Class I - Dangerous
The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.