Class I - Dangerous
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.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Mallinckrodt Pharmaceuticals Ireland
Class I - Dangerous
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 and is not intended for customer use.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
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 number was printed on the KWIK-STIK" canister label and KWIK-STIK" device label.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
Class I - Dangerous
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 disk diffusion method used for product release.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Microbiologics
Class I - Dangerous
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 disk diffusion method used for product release.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.