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.
Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW-FT18 because it may contain a 0.014" ViperWire Advance Flextip product instead of the…
Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the StrataMR Locator Tool: When the StrataMR valve is set in the incorrect orientation, higher valve…
Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of…
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of…
It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.
The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of…
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (BRF) modules with…
It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.
It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison…
For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were…
It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may enter the…
For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were…
The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assurance.
An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a…
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