Cook StoneBreaker Sterilization Cap recall — FDA Z-1594-2018
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
Complete FDA and NHTSA recall records dated in May 2018.
These records include useful source details for the selected month.
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
May produce erroneously low results from specific well sets.
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms.…
products may be missing a one-way valve on the fluid patient port.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms.…
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating…
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms.…
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself.
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No.…
There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of…
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating…
Wysong Corporation is conducting a voluntary recall of multiple varieties of Protein Key brand protein meals due to undeclared allergen soy.
Wysong Corporation is conducting a voluntary recall of multiple varieties of Protein Key brand protein meals due to undeclared allergen soy.
Ignite High Endurance Pre-Workout Supplement dietary supplement product is recalled because label declared WHEY protein but do not declare milk.
Canned spinach is being recalled due to the potential to contain boiled peanuts instead of spinach.
Wysong Corporation is conducting a voluntary recall of multiple varieties of Protein Key brand protein meals due to undeclared allergen soy.
Wysong Corporation is conducting a voluntary recall of multiple varieties of Protein Key brand protein meals due to undeclared allergen soy.
Wysong Corporation is conducting a voluntary recall of multiple varieties of Protein Key brand protein meals due to undeclared allergen soy.
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.