The sutures inside the packaging are not the same size or type as indicated on the label.
🏥
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
U by Kotex¿ Sleek¿, Regular Tampons, 18 Count
Kimberly-Clark
Class I - Dangerous
Potential for tampon to come apart upon removal.
Porcine Anorganic Bone Mineral 4.0cc
Collagen Matrix
Class I - Dangerous
There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.
Class I - Dangerous
There is a potential for silicone shedding during cleaning and sterilization.
Class I - Dangerous
The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Conformis
Class I - Dangerous
The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
Class I - Dangerous
Potentially lead to anchor breakage during insertion,
Class I - Dangerous
Potential for tampon to come apart upon removal.
BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.
Waldemar Link GmbH & Co. KG (Mfg Site)
Class I - Dangerous
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
Class I - Dangerous
There is a potential for silicone shedding during cleaning and sterilization.
Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.
Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.
The lidstock states the incorrect priming volume and flow rates.
If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.
BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.
Waldemar Link GmbH & Co. KG (Mfg Site)
Class I - Dangerous
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
U by Kotex¿ Sleek¿, Regular Tampons, 34 Count
Kimberly-Clark
Class I - Dangerous
Potential for tampon to come apart upon removal.
Class I - Dangerous
Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.
Class I - Dangerous
The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.
After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the movement button is released. Instead of stopping while the movement button is released, the Tube Head Crane moves to the intended position.
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.