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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

37,779 Total Recalls

HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930

Stradis Medical, LLC

Class I - Dangerous

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Nov 2, 2022 Other Medical Devices Nationwide View Details →

HENRY SCHEIN, Knee Pack, Item No.570-2908,

Stradis Medical, LLC

Class I - Dangerous

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Nov 2, 2022 Implants & Prosthetics Nationwide View Details →

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

Siemens Healthcare Diagnostics

Class I - Dangerous

Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

Nov 4, 2022 Diagnostic Equipment Nationwide View Details →

NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard MC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard MC2-6090R / PA0684-003 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-4590R / PA0684-004 / MAGEC 2 Rod, 4.5mm 90mm Offset MC2-5590R / PA0684-005 / MAGEC 2 Rod, 5.5mm 90mm Offset MC2-6090S / PA0684-006 / MAGEC 2 Rod, 6.0mm 70mm Standard MC2-4570S / PA0684-007 / MAGEC 2 Rod, 4.5mm 70mm Standard MC2-5570S / PA0684-008 / MAGEC 2 Rod, 5.5mm 70mm Standard MC2-6070S / PA0684-009 / MAGEC 2 Rod, 6.0mm 70mm Standard MC2-4570R / PA0684-010 / MAGEC 2 Rod, 4.5mm 70mm Offset MC2-5570R / PA0684-011 / MAGEC 2 Rod, 5.5mm 70mm Offset MC2-6070R / PA0864-012 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-5090S / PA0684-013 / MAGEC 2 Rod, 5.0mm 90mm Standard MC2-5090R / PA0684-014 / MAGEC 2 Rod, 5.0mm 90mm Offset MC2-5070S / PA0684-015 / MAGEC 2 Rod, 5.0mm 70mm Standard MC2-5070R / PA0684-016 / MAGEC 2 Rod, 5.0mm 70mm Offset

NuVasive Specialized Orthopedics

Class I - Dangerous

During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.

Nov 1, 2022 Infusion Pumps Nationwide View Details →