Device Recalls (Class II)

Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent ...

Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to preven...

Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an e...

Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be...

EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Compo...

Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Pr...

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological

CS300 IABP. Software Version CS300 IABP C.01.

Atellica CH Urine Albumin (UAlb). Material Number: 11537225

CS100 IABP. Software Version CS100 IABP Q.01.

Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and in...

Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation a...

Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy ...

Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for us...

Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008...

Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Produ...

Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150

Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy ...

Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432

Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.

MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light

Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.

Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER...

Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.

Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.

Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.

Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.

Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528

Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200

Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALY...

Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036

Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.

Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.

Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7

Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.

PIE PAK Models: P2HC-A, P2HC-S, P2HC

Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.

Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.

Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.

Campy CVA Medium 100/PK, R01272

Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.

Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707

Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7

Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Numb...

Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.

Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.

Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A

Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR

Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.

PIE Trolley System Model: 2005

Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214

Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofwa...

Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number: DYNDH1143C; ...

Estrone RIA, REF: DSL8700

Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A

Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060

MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound h...

Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 4...

Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S

Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A

Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip

Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43

Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A

Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DB...

Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These device...

MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S

Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; ...

Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerati...

Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LA...

Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip

Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A

Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691

Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; ...

Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;

Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P

Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A

Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A

Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L

Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A

Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, ...

Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437

Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721

Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip

Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBN...

Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4)...

Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip

Olympus Thunderbeat 5 mm, 10 cm, Inline Grip

Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR A...