Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
Zimmer Biomet
Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
FoundationOne CDx test report
Foundation Medicine
Class I - Dangerous
Identified potential false positive MSI-H on the test reports provided to the physicians.
GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a limited number of repaired hearing aids. The software bug caused these repaired hearing aids to contain altered specifications for sound amplification, potentially putting users residual hearing at risk of experiencing unintended additional available gain to varying degrees i.a.18dB flat linear gain or potentially in worst case Full On Gain. However, no injuries have been reported.
Class I - Dangerous
Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth.
Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S
Wright Medical Technology
Class I - Dangerous
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
Helena Laboratories
Class I - Dangerous
Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth.
ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538
Wright Medical Technology
Class I - Dangerous
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Class I - Dangerous
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
Howmedica Osteonics
Class I - Dangerous
Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
Class I - Dangerous
Inner blister pack label is incorrect and does not match the correct external box label.
Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution
Abbott Gmbh & Co. KG
Class I - Dangerous
Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.
SWANSON FINGER JOINT #2, Part Number 4700002
Wright Medical Technology
Class I - Dangerous
The firm discovered a lack of adequate documentation confirming sterility on certain products.
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.