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Atrium Medical Recalls
150 recalls on record · August 21, 2013 to October 16, 2024 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 22, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
Hazard: Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)
February 22, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or f
Hazard: Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
February 22, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid fr
Hazard: Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
February 22, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid
Hazard: Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
February 22, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To evacuate air
Hazard: Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
February 22, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate
Hazard: Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
February 22, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or
Hazard: Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
February 22, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or
Hazard: Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
February 1, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid from the chest cavity
Hazard: Outer Packaging is not sterile
February 1, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector
Hazard: Outer Packaging is not sterile
February 1, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-line connector 365
Hazard: Outer Packaging is not sterile
February 1, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) Product Usage: To evacuate
Hazard: Outer Packaging is not sterile
February 1, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. t
Hazard: Outer Packaging is not sterile
February 1, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150 Oasis singl
Hazard: Outer Packaging is not sterile
February 1, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and
Hazard: Outer Packaging is not sterile
February 1, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connecto
Hazard: Outer Packaging is not sterile
February 1, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction contr
Hazard: Outer Packaging is not sterile
February 1, 2017Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopc
Hazard: Outer Packaging is not sterile
November 23, 2016Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/
Hazard: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
November 23, 2016Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and
Hazard: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
November 23, 2016Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intended to facilitate the evacuation of air and/o
Hazard: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
November 23, 2016Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/o
Hazard: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
November 23, 2016Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid fr
Hazard: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
November 23, 2016Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to facilitate the evacuation of air and/or
Hazard: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
November 23, 2016Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuation of air and/or
Hazard: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
November 23, 2016Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or
Hazard: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
August 12, 2015Medical DevicesFDA
Atrium Medical Corporation recalls Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
Hazard: Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter
July 8, 2015Medical DevicesFDA
Atrium Medical Corporation recalls EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
Hazard: Chest drains have a missing o-ring
July 8, 2015Medical DevicesFDA
Atrium Medical Corporation recalls Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
Hazard: Chest drains have a missing o-ring
July 8, 2015Medical DevicesFDA
Atrium Medical Corporation recalls Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
Hazard: Chest drains have a missing o-ring