Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Medical Devices·276 affected·Apr 13, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e)...
Medical Devices·706 affected·Apr 13, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
Medical Devices·323 affected·Apr 13, 2018
CriticalFDA
Carefusion 303, Inc.
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected ...
Medical Devices·607,618 affected·Apr 13, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
Medical Devices·532 affected·Apr 13, 2018
High RiskFDA
Coltene Whaledent Inc
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tu...
Medical Devices·11 affected·Apr 13, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f)...
Medical Devices·1,194 affected·Apr 13, 2018
High RiskFDA
Arrow International Inc
Maximal Barrier Drape; Product Code: ASK-04000-HMC
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Maximal Barrier Drape; Product Codes: ASK-00001-1A
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703...
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Epidural Needle; Product Codes: AN-05501 and AN-05505
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Radial Arterial Access Kit; Product Code: ASK-04001-BID2
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Extension Line Slide Clamps; Product codes: SA-09847
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-H...
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Maximal Barrier Drape; Product Codes: ASK-00002-1A
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Echogenic Introducer Needle; Product Code: AN-04318
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Clear Fenestrated Drape with Adhesive; Product Code: CD-00001
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BA...
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
0.2 Micron Flat Epidural Filter; Product Code: EF-05500
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Rockwell Medical, Inc
DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to b...
Medical Devices·139 affected·Apr 7, 2018
High RiskFDA
Orthofix, Inc
Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
Medical Devices·50 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
Medical Devices·36 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
Medical Devices·30 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C
Medical Devices·100 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-0...
Medical Devices·156 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Lar...
Medical Devices·24 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)
Medical Devices·36 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Lar...
Medical Devices·0 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12M...
Medical Devices·1,206 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
Medical Devices·881 affected·Apr 6, 2018