Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
CriticalFDA
Teleflex Medical
Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, RE...
Medical Devices·1,805,730 affected·Jul 30, 2019
High RiskFDA
Eizo Corporation
RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological ima...
Medical Devices·96 affected·Jul 30, 2019
High RiskFDA
Eizo Corporation
RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, a...
Medical Devices·1,466 affected·Jul 30, 2019
CriticalFDA
Teleflex Medical
Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-2...
Medical Devices·278,142 affected·Jul 30, 2019
CriticalFDA
Teleflex Medical
Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 m...
Medical Devices·170,740 affected·Jul 30, 2019
CriticalFDA
Teleflex Medical
Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway ...
Medical Devices·7,963 affected·Jul 30, 2019
CriticalFDA
Teleflex Medical
Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Us...
Medical Devices·1,391,004 affected·Jul 30, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron F...
Medical Devices·78,877 affected·Jul 29, 2019
High RiskFDA
The Binding Site Group, Ltd.
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Medical Devices·3,294 affected·Jul 29, 2019
High RiskFDA
Motek Medical B.v.
Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functio...
Medical Devices·80 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micr...
Medical Devices·19,350 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micr...
Medical Devices·45,900 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yel...
Medical Devices·400 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yel...
Medical Devices·155,150 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit ...
Medical Devices·7,920 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set wit...
Medical Devices·120 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yel...
Medical Devices·6,516 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micr...
Medical Devices·32,416 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron F...
Medical Devices·521 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY ...
Medical Devices·170,735 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Fi...
Medical Devices·6,400 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micr...
Medical Devices·5,443 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Strip...
Medical Devices·1,536 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUMSET 15 Micron Fil...
Medical Devices·14,850 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set wit...
Medical Devices·4,600 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micr...
Medical Devices·2,327 affected·Jul 29, 2019
High RiskFDA
Becton Dickinson & Co.
BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
Medical Devices·9 affected·Jul 26, 2019
High RiskFDA
Becton Dickinson & Co.
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Medical Devices·4 affected·Jul 26, 2019
High RiskFDA
Ge Healthcare, Llc
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mo...
Medical Devices·59 affected·Jul 26, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOM...
Medical Devices·2,867 affected·Jul 25, 2019
High RiskFDA
Wilson-cook Medical Inc.
Hemospray Endoscopic Hemostat
Medical Devices·160 affected·Jul 24, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Medical Devices·27,676 affected·Jul 23, 2019
High RiskFDA
Instrumentation Laboratory Co.
ROTEM ex-tem Canada Part No: 503-05-CA
Medical Devices·44 affected·Jul 23, 2019
High RiskFDA
Instrumentation Laboratory Co.
ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
Medical Devices·722 affected·Jul 23, 2019
High RiskFDA
Instrumentation Laboratory Co.
ROTEM ex-tem; US Part No: 503-05-US
Medical Devices·364 affected·Jul 23, 2019
High RiskFDA
Aggredyne, Inc.
AggreGuide A-100 Instrument
Medical Devices·47 affected·Jul 23, 2019
High RiskFDA
Ge Healthcare, Llc
Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-...
Medical Devices·7,168 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000...
Medical Devices·19,351 affected·Jul 19, 2019
High RiskFDA
Stryker Corporation
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
Medical Devices·87 affected·Jul 19, 2019
High RiskFDA
Coltene /whaledent Ag
DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
Medical Devices·20 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006...
Medical Devices·473 affected·Jul 19, 2019
High RiskFDA
Philips North America, Llc
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedsi...
Medical Devices·280 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-931...
Medical Devices·502 affected·Jul 19, 2019
High RiskFDA
Stryker Corporation
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
Medical Devices·73 affected·Jul 19, 2019
High RiskFDA
Boston Scientific Corporation
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Medical Devices·1 affected·Jul 19, 2019
CriticalFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm FDR Go Plus mobile X-ray system
Medical Devices·174 affected·Jul 19, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Medical Devices·1 affected·Jul 18, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas c513 Analyzer
Medical Devices·2 affected·Jul 18, 2019