Complete FDA and NHTSA recall records dated in February 2023.
These records include useful source details for the selected month.
The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure…
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments…
Due to tears reported tears in the cannula due to wear and tear stress.
In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical…
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to…
Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure…
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure…
Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a normal operable state but…
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure…
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure…
The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker…
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure…
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
