Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior appr...
Medical Devices·730 affected·May 15, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
(1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management Sys...
Medical Devices·186 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the...
Medical Devices·1,965 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior app...
Medical Devices·340 affected·May 15, 2020
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250i, MEVION S250; Proton Radiation Treatment System
Medical Devices·8 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior appr...
Medical Devices·495 affected·May 15, 2020
High RiskFDA
Biomet
A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary i...
Medical Devices·3 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixati...
Medical Devices·15 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary interna...
Medical Devices·15 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for ...
Medical Devices·78 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary ...
Medical Devices·2 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary i...
Medical Devices·1 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary inte...
Medical Devices·15 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary in...
Medical Devices·1 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation a...
Medical Devices·15 affected·May 14, 2020
High RiskFDA
Biomet
Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and...
Medical Devices·10 affected·May 14, 2020
High RiskFDA
Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for t...
Medical Devices·48 affected·May 14, 2020
High RiskFDA
Diasorin Molecular Llc
MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of vari...
Medical Devices·304 affected·May 12, 2020
High RiskFDA
Diasorin Molecular Llc
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX...
Medical Devices·13,943 affected·May 12, 2020
High RiskFDA
Med Tec Inc
Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.
Medical Devices·171 affected·May 12, 2020
High RiskFDA
Merge Healthcare, Inc.
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage...
Medical Devices·62 affected·May 8, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
Medical Devices·927 affected·May 7, 2020
High RiskFDA
Umano Medical, Inc.
AC Powered hospital adjustable bed.
Medical Devices·3,259 affected·May 4, 2020
High RiskFDA
Angiodynamics, Inc.
BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the ce...
Medical Devices·119,723 affected·May 4, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative ...
Medical Devices·1,488 affected·May 4, 2020
High RiskFDA
Resource Optimization & Innovation Llc
Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing o...
Medical Devices·12,640 affected·May 4, 2020
High RiskFDA
Angiodynamics, Inc.
BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous...
Medical Devices·119,723 affected·May 4, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative dete...
Medical Devices·8,261 affected·May 4, 2020
High RiskFDA
Elekta, Inc.
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments an...
Medical Devices·32 affected·Apr 30, 2020
High RiskFDA
Normand-info S.a.s.u.
Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for...
Medical Devices·663 affected·Apr 30, 2020
High RiskFDA
Cook Inc.
Pressure Monitoring Set, C-PMS, G02838
Medical Devices·6,792 affected·Apr 30, 2020
High RiskFDA
Diasol, Inc
DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Medical Devices·212 affected·Apr 30, 2020
High RiskFDA
Hill-rom, Inc.
Centrella Smart+ Bed, Catalog Number P7900
Medical Devices·4,381 affected·Apr 30, 2020
High RiskFDA
Thermo Fisher Scientific (monterrey)
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used fo...
Medical Devices·78,600 affected·Apr 29, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
Medical Devices·240 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
Medical Devices·325 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
Medical Devices·768 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
Medical Devices·48 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
Medical Devices·72 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
Medical Devices·984 affected·Apr 24, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The...
Medical Devices·36 affected·Apr 24, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. T...
Medical Devices·41 affected·Apr 24, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The...
Medical Devices·6 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
Medical Devices·24 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
Medical Devices·220 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
Medical Devices·420 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
Medical Devices·860 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
Medical Devices·600 affected·Apr 24, 2020