Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Prism Medical Services Usa
BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for exa...
Medical Devices·5 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are i...
Medical Devices·6,990 affected·May 23, 2013
High RiskFDA
Prism Medical Services Usa
BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patien...
Medical Devices·10 affected·May 23, 2013
High RiskFDA
Prism Medical Services Usa
BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for e...
Medical Devices·1 affected·May 23, 2013
High RiskFDA
Pinook-usa
Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.
Medical Devices·28,994 affected·May 23, 2013
High RiskFDA
Sotera Wireless, Inc.
ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified ...
Medical Devices·90 affected·May 23, 2013
High RiskFDA
Baxter Healthcare Corp.
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock...
Medical Devices·629,280 affected·May 21, 2013
High RiskFDA
Olympus America Inc.
Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during e...
Medical Devices·263 affected·May 20, 2013
High RiskFDA
Steris Corporation
STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adj...
Medical Devices·16 affected·May 20, 2013
High RiskFDA
Rf Technologies, Inc.
Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a ...
Medical Devices·167 affected·May 17, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines...
Medical Devices·537 affected·May 16, 2013
High RiskFDA
The Standing Company
Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mo...
Medical Devices·119 affected·May 16, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-...
Medical Devices·204,205 affected·May 16, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time t...
Medical Devices·3,343 affected·May 16, 2013
High RiskFDA
Biomet, Inc.
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of ...
Medical Devices·17 affected·May 15, 2013
High RiskFDA
Baxter Healthcare Corp.
Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) ...
Medical Devices·530,488 affected·May 15, 2013
High RiskFDA
Baxter Healthcare Corp.
Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: ...
Medical Devices·356,728 affected·May 15, 2013
High RiskFDA
Baxter Healthcare Corp.
Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m) ...
Medical Devices·249,576 affected·May 15, 2013
RecallFDA
Optovue, Inc.
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Medical Devices·329 affected·May 14, 2013
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric...
Medical Devices·100 affected·May 14, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens AXIOM Artis zeego x-ray, angiographic system
Medical Devices·132 affected·May 13, 2013
High RiskFDA
Coloplast Manufacturing Us, Llc
Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device ...
Medical Devices·772 affected·May 13, 2013
High RiskFDA
Spinefrontier, Inc.
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 5...
Medical Devices·12 affected·May 10, 2013
CriticalFDA
Symbios Medical Products, Llc
Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found in the following kits GoBlock Kit 510472, Dispo...
Medical Devices·0 affected·May 10, 2013
CriticalFDA
Symbios Medical Products, Llc
Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; foun...
Medical Devices·33,543 affected·May 10, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measu...
Medical Devices·51,792 affected·May 10, 2013
High RiskFDA
Rauland-borg Corp
Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects te...
Medical Devices·351,000 affected·May 10, 2013
High RiskFDA
Ergosafe Product Llc Dba Prism Medical Services
400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use i...
Medical Devices·514 affected·May 10, 2013
CriticalFDA
Symbios Medical Products, Llc
Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock ...
Medical Devices·33 affected·May 10, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to qu...
Medical Devices·172,913 affected·May 10, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siem...
Medical Devices·262 affected·May 10, 2013
CriticalFDA
Verathon, Inc.
GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: The GlideScope Video L...
Medical Devices·4,784 affected·May 8, 2013
High RiskFDA
Zimmer Surgical Inc
Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickn...
Medical Devices·126 affected·May 7, 2013
High RiskFDA
Zimmer Surgical Inc
The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness ...
Medical Devices·84 affected·May 7, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Medical Devices·4 affected·May 7, 2013
High RiskFDA
Zimmer Surgical Inc
Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable gr...
Medical Devices·13 affected·May 7, 2013
High RiskFDA
Medical Information Technology, Inc.
MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) ...
Medical Devices·56 affected·May 7, 2013
High RiskFDA
Covidien Lp
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm troca...
Medical Devices·2,716 affected·May 6, 2013
High RiskFDA
Covidien Lp
Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm tr...
Medical Devices·5,364 affected·May 6, 2013
High RiskFDA
Alphatec Spine, Inc.
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segm...
Medical Devices·1,814 affected·May 6, 2013
High RiskFDA
Covidien Lp
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm tro...
Medical Devices·23,050 affected·May 6, 2013
High RiskFDA
The Anspach Effort, Inc.
Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and...
Medical Devices·183 affected·May 6, 2013
High RiskFDA
Covidien Lp
Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are i...
Medical Devices·2,705 affected·May 6, 2013
High RiskFDA
Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·45 affected·May 6, 2013
High RiskFDA
Covidien Lp
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are...
Medical Devices·126,925 affected·May 6, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the...
Medical Devices·17,719 affected·May 6, 2013
High RiskFDA
Nipro Medical Corporation
NIPRO Safe Touch Safety Scalp Vein Set
Medical Devices·176,000 affected·May 4, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609 - CLEAR-TRAC Flexible Can...
Medical Devices·73 affected·May 3, 2013