Complete FDA and NHTSA recall records dated in May 2022.
These records include useful source details for the selected month.
Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural…
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement,…
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular…
Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular…
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular…
Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and…
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality…
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into Total Resources Intl kits. Acetaminophen and electrolyte tablets were recalled due to a…
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
The device was not cleared for U.S. distribution.
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
Undeclared Soy Lecithin. Firm used Canola Oil spray as a releasing agent but finished products labels do not declare Soy Lecithin.
Undeclared Soy Lecithin. Firm used Canola Oil spray as a releasing agent but finished products labels do not declare Soy Lecithin.
Undeclared Soy Lecithin. Firm used Canola Oil spray as a releasing agent but finished products labels do not declare Soy Lecithin.
Undeclared Soy Lecithin. Firm used Canola Oil spray as a releasing agent but finished products labels do not declare Soy Lecithin.
Undeclared Soy Lecithin. Firm used Canola Oil spray as a releasing agent but finished products labels do not declare Soy Lecithin.
The firm received a positive test result for Listeria monocytogenes for the product.
The firm was notified by a customer that the label does not declare pecans in its ingredient statement.
Undeclared Soy Lecithin. Firm used Canola Oil spray as a releasing agent but finished products labels do not declare Soy Lecithin.
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.
