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All Product Recalls

49,209 recalls (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Ivoclar Vivadent Ag
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxi...
Medical Devices·6 affected·Apr 13, 2020
High RiskFDA
Ivoclar Vivadent Ag
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide...
Medical Devices·332 affected·Apr 13, 2020
High RiskFDA
Ivoclar Vivadent Ag
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxid...
Medical Devices·639 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90155, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Custom Packs to be used in surgical procedures.
Surgical Devices·2 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90177, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 1088885...
Medical Implants·211 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90163, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
Philips North America, Llc
Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows,...
Diagnostic Devices·1,075 affected·Apr 13, 2020
High RiskFDA
Philips North America, Llc
Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnost...
Surgical Devices·25 affected·Apr 10, 2020
High RiskFDA
Philips North America, Llc
HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Pro...
Cardiac Devices·8 affected·Apr 10, 2020
High RiskFDA
Philips North America, Llc
Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnost...
Surgical Devices·25 affected·Apr 10, 2020
High RiskFDA
Bd Switzerland Sarl
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Micro...
Medical Devices·110,350 affected·Apr 9, 2020
High RiskFDA
Bd Switzerland Sarl
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product U...
Medical Devices·110,350 affected·Apr 9, 2020
High RiskFDA
The Binding Site Group, Ltd.
The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry A...
Diagnostic Devices·36 affected·Apr 9, 2020
High RiskFDA
Coopersurgical, Inc.
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Surgical Devices·1,740 affected·Apr 9, 2020
High RiskFDA
Bd Switzerland Sarl
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Micro...
Medical Devices·110,350 affected·Apr 9, 2020
High RiskFDA
Wright Medical Technology Inc
WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by...
Medical Devices·22 affected·Apr 9, 2020
High RiskFDA
Qiagen Sciences Llc
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Medical Devices·530 affected·Apr 8, 2020
High RiskFDA
Argon Medical Devices, Inc
PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indic...
Surgical Devices·80 affected·Apr 8, 2020
High RiskFDA
Inpeco S.a.
Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2...
Medical Devices·23 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use in the replacement...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacemen...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in t...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Inpeco S.a.
Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka A...
Medical Devices·82 affected·Apr 7, 2020
High RiskFDA
Inpeco S.a.
Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N...
Medical Devices·3 affected·Apr 7, 2020
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit
Medical Devices·5 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the rep...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement...
Medical Devices·0 affected·Apr 7, 2020