Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 220 of 548
FDA Devices Moderate May 6, 2020
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
GE Healthcare, LLC
FDA Devices Low May 6, 2020
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Ortho Clinical Diagnostics
FDA Devices Moderate May 6, 2020
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients…
Elekta Inc
FDA Devices Moderate May 6, 2020
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare Corporation
FDA Devices Moderate May 6, 2020
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare Corporation
CPSC Moderate Apr 30, 2020
Bellman & Symfon Recalls Flash Receivers for Reduced Hearing Persons; Unit Can Fail to Alert in an Emergency
Bellman & Symfon AB, of Sweden
FDA Devices Moderate Apr 29, 2020
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180/280, 190/29…
Medivators, Inc.
FDA Devices Moderate Apr 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
FDA Devices Moderate Apr 29, 2020
ClearCanvas RIS/PACS
Synaptive Medical Inc
FDA Devices Moderate Apr 29, 2020
Olympus Pleuravideoscope, Model LTF-160
Olympus Corporation of the Americas
FDA Devices Moderate Apr 29, 2020
Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
Boston Scientific
FDA Devices Moderate Apr 29, 2020
Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
Boston Scientific
FDA Devices Moderate Apr 29, 2020
Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
Boston Scientific
FDA Devices Moderate Apr 29, 2020
Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pump along wit…
Medivators, Inc.
FDA Devices Moderate Apr 29, 2020
Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympu…
Medivators, Inc.
FDA Devices Moderate Apr 29, 2020
Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Carolina Liquid Chemistries Corp
FDA Devices Moderate Apr 29, 2020
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care set…
Radiometer Medical ApS
FDA Devices Moderate Apr 29, 2020
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
Boston Scientific
FDA Devices Moderate Apr 29, 2020
The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine …
Biomerieux Inc
FDA Devices Moderate Apr 29, 2020
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, …
Radiometer Medical ApS
FDA Devices Moderate Apr 29, 2020
Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to reli…
Biomet, Inc.
FDA Devices Moderate Apr 29, 2020
Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
Boston Scientific
FDA Devices Moderate Apr 29, 2020
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
Smith & Nephew, Inc.
FDA Devices Moderate Apr 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
FDA Devices Moderate Apr 29, 2020
TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-5…
Radiometer Medical ApS
FDA Devices Moderate Apr 29, 2020
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., w…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Apr 29, 2020
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUE…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Apr 29, 2020
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
Acutus Medical Inc
FDA Devices Moderate Apr 29, 2020
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Abbott Gmbh & Co. KG
FDA Devices Moderate Apr 29, 2020
Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endost…
Medivators, Inc.
FDA Devices Moderate Apr 29, 2020
ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
Johnson & Johnson Vision Care, Inc.
FDA Devices Moderate Apr 29, 2020
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Sys…
Beckman Coulter Inc.
FDA Devices Moderate Apr 29, 2020
Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
Boston Scientific
FDA Devices Moderate Apr 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
FDA Devices Moderate Apr 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
FDA Devices Moderate Apr 29, 2020
Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
Boston Scientific
FDA Devices Moderate Apr 29, 2020
Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
Acutus Medical Inc
FDA Devices Moderate Apr 29, 2020
RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to co…
Rayner Intraocular Lenses Limited
FDA Devices Moderate Apr 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
FDA Devices Moderate Apr 29, 2020
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus 140/240, 160…
Medivators, Inc.
FDA Devices Moderate Apr 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
FDA Devices Moderate Apr 29, 2020
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): …
CSL Behring GmbH
FDA Devices Moderate Apr 29, 2020
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for Olympus 140/2…
Medivators, Inc.
FDA Devices Moderate Apr 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
FDA Devices Moderate Apr 29, 2020
Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
Boston Scientific
FDA Devices Moderate Apr 29, 2020
Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
Acutus Medical Inc
CPSC Moderate Apr 23, 2020
Leviton Manufacturing Recalls Electrical Connection Devices Due to Shock Hazard
Leviton Manufacturing Co. Inc., of Melville, N.Y.
CPSC Moderate Apr 23, 2020
LUS Recalls Hair Dryers Due to Electrocution or Shock Hazard (Recall Alert)
FDA Drug Moderate Apr 22, 2020
Testosterone w/ Atrevis 100 mg/mL GEL, 90 gm pump, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
FDA Devices Moderate Apr 22, 2020
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Sysmex America, Inc.