Complete FDA and NHTSA recall records dated in October 2019.
These records include useful source details for the selected month.
Honda (American Honda Motor Co.) is recalling certain 2019-2020 Pilot and 2019 Passport vehicles. The front frame left and right side upper members may not have been welded completely to…
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize…
Incomplete packaging seal of sterile product
Incomplete packaging seal of sterile product
May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under…
NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at…
NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show…
A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use.
Potential for the wire to fracture at the threads and remain in the glenoid.
The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A,…
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize…
Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at…
Incomplete packaging seal of sterile product
Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a catheter 16cm…
The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
Potential for certain GRIPPER Needles to contain an occluded or blocked needle.
Potential for the Semi-Rigid canister lid to fragment during use.
A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use.
Incomplete packaging seal of sterile product
An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases
Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at…
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.
