There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from the Tube Head Mount and potentially fall off the system.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G
AROA Biosurgery
Class I - Dangerous
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
Stryker Medical Division of Stryker
Class I - Dangerous
The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G
AROA Biosurgery
Class I - Dangerous
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G
AROA Biosurgery
Class I - Dangerous
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.
AIA-900 Analyzer, Product code 022930, 022930R
Tosoh Bioscience
Class I - Dangerous
Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported.
Class I - Dangerous
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
INFUSE Bone Graft X SMALL KIT REF 7510100
Medtronic Sofamor Danek USA
Class I - Dangerous
The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Collagen Matrix
Class I - Dangerous
There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the box are correct.
Class I - Dangerous
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
AROA Biosurgery
Class I - Dangerous
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Class I - Dangerous
The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard
Class I - Dangerous
Powdered Surgical Gloves are an FDA banned substance.
Laser engraved label does not match with the item in the package
Class I - Dangerous
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Class I - Dangerous
Potential for outer pouch sterile barrier to be compromised