Complete FDA and NHTSA recall records dated in November 2020.
These records include useful source details for the selected month.
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
The product did not receive pre-market approval or clearance.
Lidl US, LLC has initiated a recall of Lidl Organic Butter Microwave Popcorn, 3 x 3.3oz, 10 boxes per case and 3 popcorn bags per box. Best by/Lot Codes: JUL192021N2, JUL232021N2,…
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Ford Motor Company (Ford) is recalling certain 2020 Explorer and Lincoln Aviator vehicles equipped with a 2.0L or 3.3L engine and a 10 Speed Automatic Transmission with the All Wheel Drive…
General Motors LLC (GM) is recalling certain 2020 Buick Enclave, Cadillac XT5, GMC Acadia and Chevrolet Traverse vehicles and 2020-2021 Chevrolet Silverado 1500, GMC Sierra 1500 vehicles.…
Nissan North America, Inc. (Nissan) is recalling certain 2020 Altima S grade vehicles equipped with Continental ProContact TX tires, size 215/60 R16 H, with TIN date code 3320 and Mold ID…
QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).
Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur…
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on…
Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles.…
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.
