CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
All Recalls
95,050 total recalls in our database
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
Compass Health Brands (Corporate Office)
Product design change did not receive proper premarket clearance and lacks a 510 (k)
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Devices were delivered without the required dry ice.
Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Shippert Medical Technologies
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Devices were delivered without the required dry ice.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Philips North America
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Devices were delivered without the required dry ice.
Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003
Moller Vital
The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall.
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
M200 Fall Monitoring System
Stanley Security Solutions
Damaged capacitor on the printed circuit board.