Smiths Medical ASD Custom Made Tracheostomy Device The CADD Administration Sets with Flow recall — FDA Z-0577-2018
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter…
Implant kit mislabeled
Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.
Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning…
Central venous catheters may not fit over guide wire potentially causing procedure delay.
Cut resistant surgical glove liners lack sterility assurance.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter…
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter…
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter…
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended…
BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations…
The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen
Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
Central venous catheters may not fit over guide wire potentially causing procedure delay.
Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.
Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single…
Central venous catheters may not fit over guide wire potentially causing procedure delay.
Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET…
The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit…
The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect implant size…
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter…
Browse recent months with enough recall history for useful comparison.