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High RiskFDA
New Vitalis Pharmacy Llc Dba New Vitalis Pharmacy
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 m...
Drugs·102 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device
Surgical Devices·2 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical device
Surgical Devices·0 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical ...
Surgical Devices·1 affected·Jul 13, 2023
High RiskFDA
Instrumentation Laboratory
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrino...
Diagnostic Devices·2,068 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscopic surgical device
Surgical Devices·1 affected·Jul 13, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Medical Devices·796 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device
Surgical Devices·0 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
Surgical Devices·3 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device
Surgical Devices·4 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical device
Surgical Devices·0 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endoscopic surgical device
Surgical Devices·7 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; endoscopic surgical device
Surgical Devices·3 affected·Jul 13, 2023
High RiskFDA
Landauer
nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosimeter used with t...
Medical Devices·211,815 affected·Jul 12, 2023
High RiskFDA
Landauer
nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring dosimeter used with...
Medical Devices·18,638 affected·Jul 12, 2023
High RiskFDA
Landauer
Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation monitoring dosimeter...
Medical Devices·512 affected·Jul 12, 2023
High RiskFDA
Olympus Corporation Of The Americas
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC...
Medical Devices·29,590 affected·Jul 12, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc.
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a)...
Medical Devices·108 affected·Jul 12, 2023
High RiskFDA
Landauer
QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers
Medical Devices·0 affected·Jul 12, 2023
High RiskFDA
Landauer
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
Medical Devices·16,820 affected·Jul 12, 2023
High RiskFDA
Landauer
Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers
Medical Devices·0 affected·Jul 12, 2023
High RiskFDA
Landauer
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; radiation monitoring dosimeter used wit...
Medical Devices·3,947 affected·Jul 12, 2023
High RiskFDA
Landauer
nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTAR readers
Medical Devices·135 affected·Jul 12, 2023
High RiskFDA
Landauer
nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR readers
Medical Devices·16,760 affected·Jul 12, 2023
High RiskFDA
Landauer
nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR readers
Medical Devices·147 affected·Jul 12, 2023
High RiskFDA
Landauer
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b) 04225-KIT; c) 04225-SET; radiation monitoring ...
Medical Devices·1,440 affected·Jul 12, 2023
High RiskFDA
Medicrea International
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebr...
Medical Devices·0 affected·Jul 12, 2023
High RiskFDA
Landauer
nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) 03053-SMO; radiation monitoring dosi...
Medical Devices·35,681 affected·Jul 12, 2023
High RiskFDA
Medicrea International
IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B2024020...
Medical Devices·0 affected·Jul 12, 2023
High RiskFDA
Medtronic Sofamor Danek Usa, Inc
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Medical Devices·13 affected·Jul 12, 2023
High RiskFDA
Landauer
nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers
Medical Devices·36,805 affected·Jul 12, 2023
High RiskFDA
Landauer
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring dosimeter used with the m...
Medical Devices·3,570 affected·Jul 12, 2023
High RiskFDA
Medicrea International
IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773...
Medical Devices·4,489 affected·Jul 12, 2023
High RiskFDA
Landauer
nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c) 03056-3MO; d) 03056-KIT; radiation monito...
Medical Devices·535,643 affected·Jul 12, 2023
High RiskFDA
Landauer
QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR readers
Medical Devices·0 affected·Jul 12, 2023
High RiskFDA
Landauer
NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
Medical Devices·310 affected·Jul 12, 2023
High RiskFDA
Landauer
Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) 18155-KIT; radiation monitoring dosimeter...
Medical Devices·1,880 affected·Jul 12, 2023
High RiskFDA
Landauer
Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTAR readers
Medical Devices·0 affected·Jul 12, 2023
CriticalFDA
Draeger Medical, Inc.
Carina Sub-Acute Care Ventilator
Respiratory Devices·11,621 affected·Jul 12, 2023
High RiskFDA
Landauer
nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosimeter used with t...
Medical Devices·68,007 affected·Jul 12, 2023
High RiskFDA
Landauer
Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring dosimeter used with the microSTAR readers
Medical Devices·0 affected·Jul 12, 2023
High RiskFDA
Medicrea International
IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
Medical Devices·11 affected·Jul 12, 2023
High RiskFDA
Landauer
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiation monitoring dosimeter used with the m...
Medical Devices·10,741 affected·Jul 12, 2023
High RiskFDA
Medicrea International
GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿...
Medical Devices·0 affected·Jul 12, 2023
High RiskFDA
Landauer
nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosimeter used with t...
Medical Devices·13,950 affected·Jul 12, 2023
High RiskFDA
Medicrea International
IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B2017196...
Medical Devices·0 affected·Jul 12, 2023
High RiskFDA
Abbott Diabetes Care, Inc.
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Medical Devices·1,722,645 affected·Jul 12, 2023
High RiskFDA
Landauer
nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers
Medical Devices·16,820 affected·Jul 12, 2023