Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
St Jude Medical Cardiac Rhythm Management Division
Class I - Dangerous
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
Siemens Medical Solutions USA
Class I - Dangerous
To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished and shipped to the customer.
Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol.
Valeant Pharmacueticals International
Class I - Dangerous
The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
Iba Dosimetry Gmbh
Class I - Dangerous
When the electric lift table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner.
Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
DePuy Mitek, Inc., a Johnson & Johnson
Class I - Dangerous
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
MWT Materials
Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
DePuy Mitek, Inc., a Johnson & Johnson
Class I - Dangerous
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Class I - Dangerous
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Class I - Dangerous
One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.
Class I - Dangerous
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Class I - Dangerous
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
Class I - Dangerous
A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term Backup battery).
Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.