FDA (Device enforcement)

11,102 recalls · page 50 of 112

• RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.2024-03-28
• RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.2024-03-28
• RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.2024-03-28
• RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.2024-03-28
• Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D2024-03-27
• Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D2024-03-27
• Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D2024-03-27
• Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-46012024-03-27
• Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-4752024-03-27
• Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,UK, Product Code 34BFST-4; c) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,AU, Product Code 2024-03-26
• Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/UK, VS100-4; c) SPOT VISION SCREENER,W/O CASE,PLUG7/SA, VS100-7; d) SPOT VISION SCREENER,W/CASE,PLUG2/EUR, VS100S-2; e) SPO2024-03-26
• Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS II POWER CORD - AUSTRALIA, 716010; c) PLFM CLASS II POWER CORD - EUROPE, 716012; d) POWER CORD,AUSTRALIA,2.5A,250V,2.5M,C7, 008-0910-00; e) POWER CORD,EUROPEAN,2.5A,250V,2.5M,C7, 008-02024-03-26
• Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.2024-03-26
• BiPAP V30 Auto Ventilator, Part Number 11111782024-03-26
• BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S122024-03-26
• BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R11111812024-03-26
• AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.2024-03-25
• RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component2024-03-25
• RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component2024-03-25
• RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component2024-03-25
• RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component2024-03-25
• 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come with multiport adapters.2024-03-23
• Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.2024-03-22
• LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL15002024-03-22
• LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K2024-03-22
• 1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K2024-03-22
• 1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR539262024-03-22
• 1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR539292024-03-22
• 1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG2024-03-22
• Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIRCUIT PEDS-LF, REF DYNJAP9918A; c) CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F2024-03-22
• Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR, REF DYNJ902387K, h) VASCULAR III, 2024-03-22
• Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d) NASAL SINUS-LF, REF DYNJ902624G; e) ORAL, REF DYNJ902377I; f) PACK,BRONCHOSCOPY, REF DYNJ65475B; g) PACK,HEAD AND NECK, REF DYNJ65487B; h) PACK,SINUS, REF DYNJ92024-03-22
• Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROSCOPY, REF DYNJ902385I; f) GENERAL LAPAROSCOPY, REF DYNJ905508G; g) GENERAL LAPAROSCOPY V, REF DYNJS2032D; h) L2024-03-22
• Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E12024-03-22
• Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A2024-03-22
• Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM20332024-03-22
• Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F; e) EGD REG KIT, REF DYKE1830; f) ENDO KIT, REF DYKE1516A; g) ERCP REG KIT, REF DYKM2127; h) GI PACK, REF DYKE1898; i) KIT, PEG, REG, RE2024-03-22
• Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM21692024-03-22
• Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF DYNJ905510D; c) NEURO, REF DYNJ902388L; d) NEURO SAS, REF DYNJ9085662024-03-22
• Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GYN LAPAROSCOPY, REF DYNJ902371J; d) GYN LAPAROSCOPY, REF DYNJ905509F; e) GYN LAPAROSCOPY II, REF DYNJS2030F; f) LAP ROBOTIC, REF DYNJ902384K; g) LAPAROSCOPY-ROBOT, REF DYNJ905003C; h) ROBO2024-03-22
• Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998C2024-03-22
• Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c) EXTREMITY, REF DYNJ900847A; d) HAND-LF, REF DYNJ902619G; e) HIP PINNING CDS, REF CDS984009C; f) HIP PINNING/TFN/ANTERIOR HIP, REF DYNJ902380K; g) KNEE, REF DYNJ904771B; h) KNEE ARTHROSC2024-03-22
• AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.2024-03-21
• AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.2024-03-21
• AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.2024-03-21
• Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego-2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H749085262202; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter2024-03-21
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter2024-03-21
• Dr¿ger Perseus A500 Anesthesia Workstation2024-03-20
• Alinity m System, Part Number: 08N53-0022024-03-20
• 3M Durapore Surgical Tape, Catalog Number 1538-1182024-03-20
• ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-042024-03-20
• ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-062024-03-20
• ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-082024-03-20