Complete FDA and NHTSA recall records dated in February 2022.
These records include useful source details for the selected month.
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot…
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process…
The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.
Potential contamination with S. epidermidis E. coli and S. warneri.
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone…
Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause…
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone…
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the…
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone…
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone…
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.
