Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. ...
Complaints of the ceramic tip of the resection sheath breaking have been received.
MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE appr...
Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KI...
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urolo...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. R...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI17...
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET ...
Knee and Humeral socket implants contain incorrect labeling.
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Res...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. ...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product ...
During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHL...
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Lack of 510K clearance
Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatm...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model...
Knee and Humeral socket implants contain incorrect labeling.
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatmen...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urolog...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; ...
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosi...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment i...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Sali...
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.