Complete FDA and NHTSA recall records dated in October 2019.
These records include useful source details for the selected month.
The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if used in…
Incomplete packaging seal of sterile product
A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use.
It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when…
Potential for certain GRIPPER Needles to contain an occluded or blocked needle.
Incomplete packaging seal of sterile product
Potential ability to leak once used for compounding.
Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff…
Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize…
There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.
Separation of front and rear barrels upon activation of the safety feature that retracts the needle
Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize…
Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at…
Potential contamination from Listeria monocytogenes.
Products contain chicken which has been recalled by supplier because it may be contaminated with Listeria monocytogenes
Inaccurate Nutrition Facts and ingredient declaration including undeclared almonds, cashews, and pecans
Notified by customer of presumptive positive results for Enterohemorrhagic E. coli (ECHEC)/Shiga Toxin-Producing E. coli (STEC) in fresh spinach.
Calcium Complex label does not bear a "Contains: milk" advisory in the correct format.
Products contain chicken which has been recalled by supplier because it may be contaminated with Listeria monocytogenes
Product (conventional basil) is potentially contaminated with Cyclospora.
Potential to be contaminated with Clostridium botulinum.
Chicken Salad sandwiches have the potential to be contaminated with Listeria monocytogenes.
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.
