Category
Medical Devices Recalls
15,654 medical devices recalls on record from CPSC, FDA, and USDA.
15,654 recalls
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250i
Medical Devices1 affectedOct 1, 2018
High RiskFDA
Trimed Inc.
TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Medical Devices99 affectedSep 28, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿...
Medical Devices277 affectedSep 28, 2018
High RiskFDA
Trimed Inc.
TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Medical Devices1,903 affectedSep 28, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 ...
Medical Devices890 affectedSep 28, 2018
High RiskFDA
Paragon 28, Inc.
P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single ...
Medical Devices64 affectedSep 28, 2018
High RiskFDA
Trimed Inc.
TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Medical Devices1,042 affectedSep 28, 2018
High RiskFDA
Trimed Inc.
TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita...
Medical Devices467 affectedSep 28, 2018
High RiskFDA
Ge Healthcare, Llc
Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRAD...
Medical Devices4,207 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)180335098...
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S...
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)1805424251...
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032...
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
Medical Devices0 affectedSep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)1...
Medical Devices0 affectedSep 27, 2018
CriticalFDA
Medtronic Navigation, Inc.
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedu...
Medical Devices5,487 affectedSep 26, 2018
High RiskFDA
Accuray Incorporated
CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic ra...
Medical Devices93 affectedSep 26, 2018
High RiskFDA
Becton Dickinson & Company
PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Id...
Medical Devices566,737 affectedSep 26, 2018
High RiskFDA
Ge Healthcare, Llc
Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Medical Devices1,724 affectedSep 25, 2018
High RiskFDA
Ge Healthcare, Llc
Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generi...
Medical Devices1,724 affectedSep 25, 2018
High RiskFDA
Ge Healthcare, Llc
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Medical Devices1,724 affectedSep 25, 2018
High RiskFDA
Ge Healthcare, Llc
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
Medical Devices1,724 affectedSep 25, 2018
High RiskFDA
The Metrix Company
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixtu...
Medical Devices1,512 affectedSep 21, 2018
High RiskFDA
The Metrix Company
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous a...
Medical Devices141,120 affectedSep 21, 2018
High RiskFDA
The Metrix Company
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous a...
Medical Devices234,720 affectedSep 21, 2018
High RiskFDA
The Metrix Company
ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in a...
Medical Devices332,640 affectedSep 21, 2018
High RiskFDA
Raysearch Laboratories Ab
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Medical Devices110 affectedSep 21, 2018
High RiskFDA
The Metrix Company
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixtu...
Medical Devices1,596 affectedSep 21, 2018
CriticalFDA
Maquet Datascope Corp - Cardiac Assist Division
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Medical Devices0 affectedSep 20, 2018
CriticalFDA
Maquet Datascope Corp - Cardiac Assist Division
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Medical Devices0 affectedSep 20, 2018
High RiskFDA
Encore Medical, Lp
Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
Medical Devices21 affectedSep 19, 2018
High RiskFDA
Baxter Healthcare Corporation
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Medical Devices354 affectedSep 18, 2018
High RiskFDA
Beckman Coulter Inc.
Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpe...
Medical Devices41 affectedSep 17, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI700020...
Medical Devices641 affectedSep 17, 2018