A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
All Recalls
95,025 total recalls in our database
Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
Medtronic Sofamor Danek USA
🏥 Medical Devices Class I - Dangerous
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
🏥 Medical Devices Class I - Dangerous
Device and tray that houses the device did not pass steam sterilization process validation testing
🏥 Medical Devices Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
Medtronic Sofamor Danek USA
🏥 Medical Devices Class I - Dangerous
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
🏥 Medical Devices Class I - Dangerous
Incorrect labeling of dialysate concentration for hemodialysis.
Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
Medtronic Sofamor Danek USA
🏥 Medical Devices Class I - Dangerous
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
Resource Optimization & Innovation
🏥 Medical Devices Class I - Dangerous
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
🏥 Medical Devices Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
🏥 Medical Devices Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Abaxis
🏥 Medical Devices Class I - Dangerous
Incorrect reference ranges of analytes.
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
🏥 Medical Devices Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
🏥 Medical Devices Class I - Dangerous
Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog number listed in the table above. BD has been informed by our supplier that the external threads on some of the collets (Figure 1) contain a machining burr, potentially causing the collet to not fully seat in the knife handle (Figure 2), inhibiting complete grip of the inserted knife blade possibly resulting in a loose blade.
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg. to +/- 6 deg. This limitation may lead to difficulties in removing the vacuum biopsy system.
🏥 Medical Devices Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
🏥 Medical Devices Class I - Dangerous
Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
🏥 Medical Devices Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
🏥 Medical Devices Class I - Dangerous
Device and tray that houses the device did not pass steam sterilization process validation testing