Complete FDA and NHTSA recall records dated in May 2022.
These records include useful source details for the selected month.
Ford Motor Company (Ford) is recalling certain 2019-2020 Mustang vehicles equipped with 5.0L engines and manual transmissions. The Powertrain Control Module (PCM) may broadcast an…
General Motors, LLC (GM) is recalling certain 2022 GMC Canyon and Chevrolet Colorado vehicles equipped with a manual passenger seat. The front passenger seat may have a hook attachment that…
Honda (American Honda Motor Co.) is recalling certain 2020 CR-V vehicles. The clip for the absorber inside the fuel tank was not secured properly and may detach, which can cause an…
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
There is a potential that the proximal marker may separate from the imaging catheter
Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug recall due to uncertainty of the…
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
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,…
Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD)…
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…
It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.
Products in this lot may have compromised barrier seals, introducing a risk to sterility.
Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer…
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
Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.
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…
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…
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…
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…
Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient…
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,…
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…
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…
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.
