Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Optovue Inc.
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped w...
Medical Devices·795 affected·Sep 7, 2012
CriticalFDA
Baxter Healthcare Corp.
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV f...
Medical Devices·1,995,040 affected·Sep 7, 2012
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation d...
Medical Devices·757 affected·Sep 7, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone ...
Medical Devices·314 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to b...
Medical Devices·94 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are primarily used to re-attach sof...
Medical Devices·39,362 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to b...
Medical Devices·400 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in ...
Medical Devices·7 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone...
Medical Devices·0 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 SPIRALOK Anchors are primarily used to re-attach sof...
Medical Devices·4,321 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repai...
Medical Devices·66 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone ...
Medical Devices·1,315 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone ...
Medical Devices·372 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in ...
Medical Devices·7 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone...
Medical Devices·0 affected·Sep 6, 2012
High RiskFDA
The Anspach Effort, Inc.
Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed f...
Medical Devices·8 affected·Sep 5, 2012
High RiskFDA
Wright Medical Technology Inc
Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Num...
Medical Devices·729 affected·Sep 5, 2012
High RiskFDA
Wright Medical Technology Inc
Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X...
Medical Devices·840 affected·Sep 5, 2012
High RiskFDA
Zimmer, Inc.
Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw
Medical Devices·1,406 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
NCB¿ screw ¿ 4.0 self-tapping
Medical Devices·41 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Anatomical Shoulder" Fracture Humeral stem
Medical Devices·139 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Alloclassic SL Shaft
Medical Devices·1,355 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx
Medical Devices·74 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Biolox¿ Option Ceramic Femoral Head System Rx, sterile
Medical Devices·88 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345, G...
Medical Devices·164 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Anatomical Shoulder" Inverse Humeral Cup
Medical Devices·66 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx
Medical Devices·228 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Dynesys¿ Revision + set screw
Medical Devices·1,575 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
MS-30¿ Stem
Medical Devices·30 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Anatomical Shoulder" Humeral stem
Medical Devices·260 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
MS-30¿ Distal centralizer, cemented, sterile, Rx
Medical Devices·58 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
CLS Stem
Medical Devices·18 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Original M.E. Mueller" Low Profile Cup Sterile, Rx
Medical Devices·6 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Anatomical Shoulder" Humeral Head
Medical Devices·224 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
NCB¿ cancellous screw
Medical Devices·2 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Kopf Adapter S Sterile, Rx
Medical Devices·2,011 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Fitmore" Hip Stem
Medical Devices·1,190 affected·Sep 4, 2012
High RiskFDA
Beckman Coulter Inc.
UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, comput...
Medical Devices·7 affected·Sep 3, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by com...
Medical Devices·257 affected·Aug 31, 2012
High RiskFDA
Bausch & Lomb Inc
Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and ...
Medical Devices·124 affected·Aug 31, 2012
High RiskFDA
Accuro Medical Product Llc
Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 6...
Medical Devices·919 affected·Aug 31, 2012
High RiskFDA
Stryker Sustainability Solutions
STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT...
Medical Devices·1,311 affected·Aug 30, 2012
High RiskFDA
Medtronic Sofamor Danek Usa Inc
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc....
Medical Devices·1,014 affected·Aug 30, 2012
High RiskFDA
Medtronic Sofamor Danek Usa Inc
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid...
Medical Devices·247 affected·Aug 30, 2012
CriticalFDA
Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, ...
Medical Devices·19,614 affected·Aug 29, 2012
CriticalFDA
Hospira Inc.
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, ...
Medical Devices·14,067 affected·Aug 29, 2012
High RiskFDA
Biomerieux Inc
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking ...
Medical Devices·350 affected·Aug 28, 2012
High RiskFDA
Hospira Inc.
Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Medical Devices·191,094 affected·Aug 28, 2012