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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Microbiologics Inc
QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) ...
Medical Devices·8 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining a...
Medical Devices·751 affected·Dec 1, 2015
High RiskFDA
Josnoe Medical, Inc.
PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
Medical Devices·1,008 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobia...
Medical Devices·2,706 affected·Dec 1, 2015
High RiskFDA
Synthes (usa) Products Llc
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
Surgical Devices·65 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automat...
Medical Devices·666 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobia...
Medical Devices·284 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining a...
Medical Devices·715 affected·Dec 1, 2015
High RiskFDA
Microbiologics Inc
QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb)...
Medical Devices·541 affected·Dec 1, 2015
High RiskFDA
Aesculap, Inc.
Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicat...
Medical Devices·1,232 affected·Nov 30, 2015
High RiskFDA
Bayer Healthcare
Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine dia...
Diagnostic Devices·198,598 affected·Nov 30, 2015
High RiskFDA
Acumedia Manufacturers, Inc.
Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the ...
Medical Devices·28 affected·Nov 30, 2015
High RiskFDA
Verathon, Inc.
GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope ...
Medical Devices·448 affected·Nov 30, 2015
High RiskFDA
Verathon, Inc.
BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 027...
Medical Devices·2,524 affected·Nov 30, 2015
High RiskFDA
Baxter Healthcare Corp.
Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: ...
Medical Devices·9,600 affected·Nov 30, 2015
High RiskFDA
Baxter Healthcare Corp.
Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory t...
Medical Devices·77,136 affected·Nov 30, 2015
High RiskFDA
Aga Gas Inc
Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01
Drugs·1,500 affected·Nov 29, 2015
High RiskFDA
Leica Microsystems, Inc.
Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intend...
Diagnostic Devices·3,745 affected·Nov 27, 2015
High RiskFDA
Biomet 3i, Llc
Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Provide Protection Cap Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Conical 25 degree Angled Abutment Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Medical Devices·5,569 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Conical 17 degree Angled Abutment Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Bellatek Encode Healing Abutment Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Medical Devices·1,880 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Conical EP Healing Cap Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Renovorx, Inc.
RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCat...
Surgical Devices·11 affected·Nov 25, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare IntelliVue Info Center iX, A.0 866023
Medical Devices·5,671 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Preformance 15 degrees Pre-Angled Post Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Micromini Flat Implant Cover Screw Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Conical EP Twist Lock TM Coping Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Richard Wolf Medical Instruments Corp.
Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intend...
Surgical Devices·0 affected·Nov 25, 2015
High RiskFDA
Richard Wolf Medical Instruments Corp.
Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an attachment or accessory to the air-powere...
Surgical Devices·0 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
DAL-RO Housing, Female Assembly Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain EP Pick-Up Coping Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
DAL-RO Abutment Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Pick-up Coping Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Gingihue 15 degree Angled Post Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Abeon Medical Corporation
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid...
Medical Implants·575 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Gold-Tite Square Uniscrew Item: UNISG Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
IOL Healing Cap Dental implants
Medical Implants·1 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Standard Abutment Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
IOL Distal Extension Dental implants
Medical Implants·1 affected·Nov 25, 2015