Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Biomerieux Inc
Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clin...
Medical Devices·1,604 affected·Mar 27, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain h...
Medical Devices·1,375 affected·Mar 26, 2015
High RiskFDA
Handicare Usa, Inc.
ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
Medical Devices·64 affected·Mar 26, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain ha...
Medical Devices·3,177 affected·Mar 26, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a cu...
Medical Devices·648 affected·Mar 26, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a c...
Medical Devices·2,711 affected·Mar 26, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a cu...
Medical Devices·1,984 affected·Mar 26, 2015
High RiskFDA
Photomedex, Inc.
Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and pr...
Medical Devices·200,188 affected·Mar 26, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain ha...
Medical Devices·120 affected·Mar 26, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a cu...
Medical Devices·6,424 affected·Mar 26, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain ha...
Medical Devices·1,457 affected·Mar 26, 2015
High RiskFDA
The Anspach Effort, Inc.
Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.
Medical Devices·12,085 affected·Mar 24, 2015
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT61...
Medical Devices·8,269 affected·Mar 23, 2015
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, I...
Medical Devices·5,125 affected·Mar 23, 2015
High RiskFDA
Smiths Medical Asd, Inc.
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
Medical Devices·5 affected·Mar 21, 2015
CriticalFDA
Hill-rom, Inc.
Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.
Medical Devices·24 affected·Mar 20, 2015
High RiskFDA
Biomet, Inc.
LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone fixation and h...
Medical Devices·45 affected·Mar 18, 2015
High RiskFDA
Zimmer Gmbh
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Medical Devices·30 affected·Mar 18, 2015
High RiskFDA
Bard Peripheral Vascular Inc
Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: ...
Medical Devices·29,342 affected·Mar 17, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by c...
Medical Devices·79 affected·Mar 17, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
Medical Devices·66 affected·Mar 17, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 16 Water. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstru...
Medical Devices·153 affected·Mar 16, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of...
Medical Devices·153 affected·Mar 16, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 16 Power. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstru...
Medical Devices·153 affected·Mar 16, 2015
High RiskFDA
Natus Medical Incorporated
Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with...
Medical Devices·2,611 affected·Mar 16, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruct...
Medical Devices·153 affected·Mar 16, 2015
High RiskFDA
Arcos, Inc
Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn ...
Medical Devices·28 affected·Mar 16, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruct...
Medical Devices·153 affected·Mar 16, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstructi...
Medical Devices·153 affected·Mar 16, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 64. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction ...
Medical Devices·153 affected·Mar 16, 2015
CriticalFDA
Lusys Laboratories, Inc.
Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol...
Medical Devices·1,015 affected·Mar 13, 2015
CriticalFDA
Lusys Laboratories, Inc.
Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alc...
Medical Devices·5 affected·Mar 13, 2015
High RiskFDA
Vital Signs Colorado Inc.
Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
Medical Devices·399 affected·Mar 13, 2015
CriticalFDA
Lusys Laboratories, Inc.
Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. A...
Medical Devices·80 affected·Mar 13, 2015
CriticalFDA
Lusys Laboratories, Inc.
Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and al...
Medical Devices·20 affected·Mar 13, 2015
CriticalFDA
Lusys Laboratories, Inc.
Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Dev...
Medical Devices·1,055 affected·Mar 13, 2015
High RiskFDA
Teleflex Medical
Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
Medical Devices·2,148 affected·Mar 13, 2015
High RiskFDA
Biomet Spine, Llc
Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine ...
Medical Devices·874 affected·Mar 12, 2015
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01....
Medical Devices·4 affected·Mar 12, 2015
High RiskFDA
Carefusion 303, Inc.
Alaris PC units, Model No. 8015. Infusion pump.
Medical Devices·56,015 affected·Mar 12, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within spee...
Medical Devices·11,423 affected·Mar 12, 2015
High RiskFDA
Biomet Spine, Llc
Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical a...
Medical Devices·148 affected·Mar 12, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce ima...
Medical Devices·975 affected·Mar 11, 2015
High RiskFDA
X Spine Systems Inc
Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw asse...
Medical Devices·14 affected·Mar 11, 2015
High RiskFDA
Us Endoscopy Group Inc
Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic pro...
Medical Devices·1,695 affected·Mar 10, 2015
High RiskFDA
Specialty Appliance Works, Inc.
TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk...
Medical Devices·14,428 affected·Mar 9, 2015
High RiskFDA
Specialty Appliance Works, Inc.
Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24 A Herbst Applian...
Medical Devices·14,428 affected·Mar 9, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the...
Medical Devices·260 affected·Mar 9, 2015