Randox Laboratories Liquid Protein Calibrators recall — FDA Z-1328-2024
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal…
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the…
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the…
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees…
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the…
May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange…
Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to…
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees…
When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the…
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the…
There is a potential for sterile package breach.
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the…
Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal…
May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange…
This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm…
Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam…
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the…
Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the…
When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on…
Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot or any…
Browse recent months with enough recall history for useful comparison.