Complete FDA and NHTSA recall records dated in December 2019.
These records include useful source details for the selected month.
A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not…
May result in readings outside of the expected accuracy range.
Patients have experienced a bad taste associated with the filters.
The tracheal and brochial swivel connectors are incorrectly labeled.
May result in readings outside of the expected accuracy range.
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length…
The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not…
The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not…
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
The product was mislabeled with an incorrect expiration date.
Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even…
A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT #188744)
The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length…
Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
May result in readings outside of the expected accuracy range.
A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software allows…
Certain product code/lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Using the affected balloon expandable vascular…
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode…
Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may…
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.
