Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Class I - Dangerous
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Class I - Dangerous
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Class I - Dangerous
Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.
Class I - Dangerous
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Class I - Dangerous
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Class I - Dangerous
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Class I - Dangerous
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Class I - Dangerous
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Class I - Dangerous
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Class I - Dangerous
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Class I - Dangerous
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Class I - Dangerous
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Class I - Dangerous
The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
Class I - Dangerous
Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall.