40 results · 26ms · Sources: EU EUDAMED, US FDA

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Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.

FDA Recall
Terminated ·Beckman Coulter Inc·Product code JIX·May 15, 2017

Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUSOnly - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUSOnly - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code GCX·December 26, 2025

Hudson RCI AQUA+ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/Anesthesia Adult/Child, Catalog number 1570, Distributed by Teleflex Medical. The Aqua+ Flex is a passive humidifier indicated for use on patients under anesthesia and intensive care to effectively warm and humidify the inspired air.

FDA Recall
Terminated ·Teleflex Medical·Product code BTT·March 19, 2010

a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog #68751510104. b. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR BARR 10X12 (5/BX) Catalog #68751510105

FDA Recall
Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code FRO·May 25, 2022

Toshiba DUA-450F Kalare Radiographic Tilting Table.

FDA Recall
Terminated ·Toshiba American Medical Systems Inc·Product code IXR·July 15, 2010

Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

FDA Recall
Terminated ·Teleflex Medical·Product code BTT·June 5, 2014

Cosmetic color soft contact lenses. Multiple colors which include Blue, Green, Aqua, Brown, Grey. BesCon (brand)

FDA Recall
Terminated ·My Cosmetics Inc·Product code LPL·November 13, 2002

Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.

FDA Recall
Open, Classified ·Maquet Cardiovascular, LLC·Product code DWS·February 9, 2022

Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

FDA Recall
Completed ·Lens.com·Product code LPM·August 14, 2018

Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

FDA Recall
Completed ·Allied Vision Group Inc·Product code LPM·August 1, 2018

X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code rad·September 7, 2004

SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine. CREm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 800 System and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine.

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code CGX·August 2, 2010

Spectrum Medical Quantum Standard heat exchanger

FDA Recall
Terminated ·QURA S.R.L. Via Di Mezzo·Product code KFM·March 22, 2021

Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

FDA Recall
Open, Classified ·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024

Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale.

FDA Recall
Terminated ·Penner Mfg Inc·Product code MMP·January 30, 2015

AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

FDA Recall
Terminated ·Teleflex Medical·Product code BTT·January 14, 2015

Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851

FDA Recall
Open, Classified ·Product code OEZ·January 30, 2026

Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site

FDA Recall
Open, Classified ·Genicon, Inc.·Product code N/A·August 25, 2020

Insulia Diabetes Management Companion

FDA Recall
Terminated ·Voluntis 22 Quai Gallieni Suresnes France·Product code NDC·October 8, 2018

ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code CEM·September 22, 2010