Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 1...
Medical Devices·133,751 affected·Feb 20, 2015
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Cana...
Medical Devices·133,751 affected·Feb 20, 2015
High RiskFDA
Optimedica Corporation
Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Ca...
Medical Devices·171 affected·Feb 20, 2015
High RiskFDA
Becton Dickinson & Company
BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Syste...
Medical Devices·315,800 affected·Feb 19, 2015
RecallFDA
Richard-allan Scientific Company
Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard...
Medical Devices·132 affected·Feb 19, 2015
High RiskFDA
Steris Corporation
AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium St...
Medical Devices·701 affected·Feb 19, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, st...
Medical Devices·4 affected·Feb 18, 2015
High RiskFDA
Us Endoscopy Group Inc
Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the bi...
Medical Devices·2,173 affected·Feb 17, 2015
High RiskFDA
Synthes, Inc.
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for ...
Medical Devices·183 affected·Feb 17, 2015
High RiskFDA
Eos Imaging Inc
EOS, Digital radiography system used in general radiographic examinations.
Medical Devices·13 affected·Feb 17, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B....
Medical Devices·13,345 affected·Feb 16, 2015
High RiskFDA
Flower Orthopedics Corporation
Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:1...
Medical Devices·901 affected·Feb 16, 2015
High RiskFDA
Brainlab Ag
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Medical Devices·24 affected·Feb 16, 2015
High RiskFDA
Medela Inc. Ef Division
- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio E...
Medical Devices·1,959,187 affected·Feb 13, 2015
High RiskFDA
Ameda, Inc.
Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 ...
Medical Devices·12 affected·Feb 12, 2015
High RiskFDA
Ameda, Inc.
Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary...
Medical Devices·1,763 affected·Feb 12, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EX...
Medical Devices·19 affected·Feb 11, 2015
Medium RiskFDA
Milestone Scientific, Inc.
Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece ...
Medical Devices·165,850 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-1...
Medical Devices·2 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager)...
Medical Devices·2 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173050G; EXP (repackager)...
Medical Devices·2 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange 3.5mm Threaded Cerclage Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 298.838S; EXP (...
Medical Devices·6 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173054...
Medical Devices·3 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-1...
Medical Devices·3 affected·Feb 11, 2015
High RiskFDA
Sybron Dental Specialties
Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single ...
Medical Devices·172 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog ...
Medical Devices·3 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog numbe...
Medical Devices·12 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-2...
Medical Devices·6 affected·Feb 11, 2015
RecallFDA
Tosoh Bioscience, Inc.
G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Varia...
Medical Devices·9 affected·Feb 10, 2015
High RiskFDA
Mrp, Llc Dba Amusa
T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 ...
Medical Devices·1,080 affected·Feb 9, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: T...
Medical Devices·12 affected·Feb 6, 2015
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temper...
Medical Devices·103 affected·Feb 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-sectional images of the ...
Medical Devices·4 affected·Feb 5, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional images of the body by...
Medical Devices·38 affected·Feb 5, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produce cross-sectional images of the body by computer reconstruc...
Medical Devices·159 affected·Feb 5, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by computer reconstruction of...
Medical Devices·82 affected·Feb 5, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Inge...
Medical Devices·424 affected·Feb 5, 2015
High RiskFDA
Remel Inc
Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid L...
Medical Devices·24 affected·Feb 5, 2015
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use w...
Medical Devices·1 affected·Feb 4, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synaps...
Medical Devices·30 affected·Feb 4, 2015
High RiskFDA
Norwex Usa Inc
Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy The product is intended for over the counter use a...
Medical Devices·35,214 affected·Feb 3, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis...
Medical Devices·1 affected·Feb 3, 2015
CriticalFDA
Invacare Corporation
Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 3...
Medical Devices·1,057 affected·Feb 2, 2015
CriticalFDA
Smiths Medical Asd, Inc.
CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
Medical Devices·48,208 affected·Feb 2, 2015
High RiskFDA
Penner Mfg Inc
Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool ...
Medical Devices·158 affected·Jan 30, 2015
High RiskFDA
Elekta, Inc.
Elekta Precise Treatment Table
Medical Devices·529 affected·Jan 29, 2015
CriticalFDA
Coopersurgical, Inc.
MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Dispos...
Medical Devices·18,696,754 affected·Jan 26, 2015
High RiskFDA
Haemonetics Corporation
Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the T...
Medical Devices·4,143 affected·Jan 26, 2015