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Class 1 Recall: Nurse Assist Inc. Recalls Normal Saline Flush IV Syringes Due to Possible Burkholderia Cepacia Bloodstream Infections

Nurse Assist Inc. is recalling the normal saline flush syringes due to incidents of Burkholderia cepacia (B. cepacia) contamination. B. cepacia is a bacterium that can cause bloodstream infections, particularly in patients with weak immune systems....


Class 1 Recall: Greatbatch Medical Recalls Standard Offset Cup Impactor Used for Hip Joint Replacement due to Inadequate Sterilization

Greatbatch Medical is recalling the Standard Offset Cup Impactor with a POM-C handle that failed sterility testing when sterilized in a dedicated instrument case....


Class 1 Recall: Centurion Recalls Multi-Med Single Lumen Catheters due to Excess Material that May Split or Separate

Centurion is recalling the Centurion Convenience Kits containing Multi-Med Single Lumen Catheters. The catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process....


Class 1 Recall: Medtronic Recalls Neurovascular Products due to Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating

Medtronic is recalling of certain lots of its Pipeline embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, and UltraFlow and Marathon flow-directed micro catheters....


Class 1 Recall: SentreHeart Recalls FindrWIRZ Guidewire System due to Coating Separation

SentreHeart is recalling the FindrWIRZ Guidewire System because the PTFE coating may separate from the packaging and potentially cause serious injuries to patients....


Class 1 Recall: TeleFlex Medical Recalls Tracheostomy Tube Set Due to Possible Disconnection During Patient Use

Teleflex is recalling the Willy Rusch Tracheostomy Tube Set due to the possibility that the connector may disconnect from the tracheostomy tube during use on a ventilated patient....


Class 1 Recall: UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) St?ckert 3T Heater-Cooler System: FDA Safety Communication

The FDA is updating its June 1, 2016 Safety Communication to provide new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the 3T in U.S. patients who have undergone cardiothoracic surgeries....


Class 1 Recall: Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices: FDA Safety Communication

FDA is providing information and recommendations regarding St. Jude Medical’s advisory on ICD and CRT-D batteries that may fail earlier than expected....


Class 1 Recall: Baxter Corporation Recalls 50 mm 0.2 Micron Filter Due to the Potential for a Missing Filter Membrane and Possible Particulate Matter Contamination

Baxter Corp. is recalling the 50 mm 0.2 Micron Filter after receiving reports about the presence of particulate matter and the potential absence of filter membrane layers in the filter set....


Class 1 Recall: DePuy Synthes Recalls Power Tool System Battery Adaptors Due to Possible Explosion Risk

DePuy Synthes is recalling the Adaptor and Light Adaptor for their SBD and SBD II due to a potential for the adaptors to produce extreme internal pressure, which may cause the device to explode....

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