Class I - Dangerous
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
Medtronic Inc., Cardiac Rhythm and Heart Failure
Class I - Dangerous
An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.
Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
Medtest Holdings
Class I - Dangerous
The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.
Class I - Dangerous
Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Class I - Dangerous
Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.
Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Teleflex Medical
Class I - Dangerous
Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.
Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
B Braun Medical
Class I - Dangerous
B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blisters to be punctured resulting in a compromised sterility barrier.
Class I - Dangerous
St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.
Class I - Dangerous
Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mechanism of the Transport Struts.
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
EBI Patient Care
Class I - Dangerous
Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
Class I - Dangerous
Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced.