Olympus ShockPulse-SE Lithotripsy System Recall (Class II)

The FDA has issued a Class II recall for the Olympus ShockPulse-SE Lithotripsy System with Generator due to a mis-wired component that may affect system reliability and cause delays. The recall impacts international distribution, including Canada, Germany, Singapore, Australia, and India.

Advanced Bionics Class II Recall - Sky CI M90 Packaging Label Mismatch

The FDA has initiated a Class II recall for Advanced Bionics' Sky CI M90 Sound Processor due to a packaging label mismatch. The recall affects product CI-5295-150, where the label on the behind-the-ear sound processor packaging does not match the included product. Distribution details are currently unknown.

ShockPulse-SE Lithotripsy System Recall

The FDA has issued a Class II device recall for Olympus Corporation of the Americas' ShockPulse-SE Lithotripsy System (Model SPL-S) due to a generator blinking issue that may cause damage to the transducer plug and generator receptacle. The recall is ongoing and has worldwide distribution.

Medline Recall: Dialysis Kits with Tego Connector Seal Defects

The FDA has initiated a Class II recall for Medline Kits containing Tego Connectors (SKU EBSI1746) due to defects in the silicone seal, which can cause occlusion. The recall impacts nationwide distribution in the US. The recall is ongoing.

Medline Industries Class II Recall - Tego Connector Silicone Seal Defect

The FDA has initiated a Class II recall for Medline Industries' Convenience kits containing Tego Connectors (SKU DYNDC3167) due to issues with the silicone seal. The defect, including doming and tearing, can lead to an occluded fluid path, preventing proper blood product injection or withdrawal. The recall affects nationwide distribution in the US.

Olympus Sheath Recall - Ceramic Tip Fractures

The FDA has issued a Class II recall for Olympus Sheath, 10 Fr. (Model No. A37004A) due to complaints of the ceramic tip breaking during use. This recall affects nationwide distribution within the US.

Encore Medical Recall: RSP Implant Incorrect Labeling

The FDA has issued a Class II recall for Encore Medical's Reverse Shoulder Prosthesis (RSP) due to incorrect labeling on knee and humeral socket implants. The recall affects nationwide distribution within the US.

Olympus Resection Sheath Recall - Ceramic Tip Breaking

The FDA has initiated a Class II recall for the Olympus Resection Sheath, Model No. A22041T, due to complaints of the ceramic tip breaking. This recall affects nationwide distribution within the US and is ongoing.

FDA Class II Device Recall: MRI LED Battery Overheating Risk (Z-1436-2026)

The FDA has issued a Class II recall (Z-1436-2026) for MRIMed Inc.'s MRI LED Mobile Exam Light Battery (REF SL-111) due to a risk of overheating, melting, and smoke during charging. The recall affects distribution worldwide, including nationwide in the U.S.

Olympus Inner Sheath Recall - Ceramic Tip Breaking

The FDA has issued a Class II recall for Olympus Inner Sheath, Model No. WA22017A, due to complaints of the ceramic tip breaking during use. This recall impacts distribution nationwide in the US and is ongoing.