Complete FDA and NHTSA recall records dated in October 2018.
These records include useful source details for the selected month.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
A potential bias was identified with certain kits compared to the internal standards.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
The product was mislabeled as containing the incorrect type of suture.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be…
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be…
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and…
The catheter failed the endotoxin testing.
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the…
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.
