Manufacturer

Atrium Medical Corporation

150 recalls in our database name Atrium Medical Corporation as the manufacturing or recalling firm.

What the numbers show

Total: 150
Critical: 2
Severe: 4
Most recent: 2024-10-16

Of the 150 recalls from Atrium Medical Corporation we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (3%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

101–125 of 150

HighFDA (Devices)·Z-1085-2017·2017-02-01
Atrium Medical Oasis Dual Chamber Drain Recall Due to Sterility Issue
Atrium Medical is recalling Oasis dual chamber drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.
Product
Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative coll
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1082-2017·2017-02-01
Atrium Medical Recalls Ocean Blood Recovery Drains Due to Sterility Issues
Atrium Medical is recalling Ocean Blood Recovery Drains because the outer packaging is not sterile. The recall affects units worldwide with expiration dates prior to October 2019.
Product
Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control stopcock 2050-300 Ocean Blood Recovery drain with suction control stopcock, no in-line connector 2052-000 Ocean Double Blood Recovery drain w
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1086-2017·2017-02-01
Atrium Medical Recalls Oasis Blood Recovery Drains Due to Sterility Issues
Atrium Medical is recalling Oasis Blood Recovery Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.
Product
Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-line connector 3652-100 Oasis Double Blood Recovery drain with in-line connectors - 2 patient lines connected by one Y connector Product Usage: To evacuate air and/or fluid f
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1079-2017·2017-02-01
Atrium Medical Ocean Drains Recalled Due to Non-Sterile Outer Packaging
Atrium Medical is recalling Ocean Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.
Product
Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Ocean single drain, in-line connector and suction control stopcock, Pedi connector in bag on back of the drain 2002-050 Ocean single drain with
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1084-2017·2017-02-01
Atrium Medical Oasis Pediatric Drain Recalled for Non-Sterile Packaging
Atrium Medical is recalling Oasis Pediatric Drains because the outer packaging is not sterile. The recall covers 964,463 US cases and 521,975 international cases.
Product
Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of drain 3612-400 Oasis Infant/Pediatric drain with no in-line connector, ¿ in. tubing, Sims and Pedi connector i
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1080-2017·2017-02-01
Atrium Medical Recalls Dual Chamber Ocean Drains Due to Sterility Issues
Atrium Medical is recalling Dual Chamber Ocean Drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.
Product
Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Patient Tubes) 2020-100 Ocean dual chamber with in-line connectors and no suction control stopcock (2 Patient Tubes) 2020-300 Ocean dual chambe
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1088-2017·2017-02-01
Atrium Medical Express Mini 500 Dry Seal Drain Recall
Atrium Medical is recalling Express Mini 500 dry seal drains because the outer packaging is not sterile.
Product
Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1087-2017·2017-02-01
Atrium Medical 400 Series Express Drains Recalled for Non-Sterile Packaging
Atrium Medical is recalling 400 Series Express Drains because the outer packaging is not sterile. The recall affects approximately 1.4 million cases distributed worldwide.
Product
Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4000-100P Express PreFilled Chest Drain 4020-100N Express dual chamber drain with in-line connectors ( 2 Patient Tubes) 4050-100N Express Blood Recovery dra
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0581-2017·2016-11-23
Atrium Medical 24 Fr Trocar Catheter Recall for Labeling Error
Atrium Medical is recalling 24 Fr Trocar Catheters because the packaging label incorrectly depicts more holes than the product actually contains.
Product
Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0579-2017·2016-11-23
Atrium Medical 16 Fr Trocar Catheter Labeling Error Recall
Atrium Medical is recalling 16 Fr Trocar Catheters because the packaging labels show more eyelets than the product actually contains.
Product
Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0583-2017·2016-11-23
Atrium Medical Recalls 32 Fr Trocar Catheters Due to Labeling Error
Atrium Medical is recalling 32 Fr Trocar catheters because the packaging label depicts more eyelets than the product actually contains.
Product
Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0578-2017·2016-11-23
Atrium Medical Recalls 12 Fr Trocar Catheters Due to Labeling Error
Atrium Medical is recalling 12 Fr Trocar catheters because the packaging labels show more holes than the product actually contains.
Product
Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0580-2017·2016-11-23
Atrium Medical Recalls Trocar Catheters Due to Labeling Error
Atrium Medical is recalling 20 Fr Trocar catheters because the packaging labels show more holes than the product actually contains.
Product
Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0576-2017·2016-11-23
Atrium Medical Recalls 8 Fr Trocar Catheters Due to Labeling Error
Atrium Medical is recalling 8 Fr Trocar catheters because the packaging label displays an icon with more holes than the actual product contains.
Product
Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0577-2017·2016-11-23
Atrium Medical Recalls Trocar Catheters Due to Inaccurate Labeling
Atrium Medical is recalling 10 Fr Trocar catheters because the packaging label displays more holes than the product actually contains.
Product
Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0582-2017·2016-11-23
Atrium Medical Recalls 28 Fr Trocar Catheters Due to Labeling Error
Atrium Medical is recalling 28 Fr Trocar catheters because the packaging label incorrectly depicts more holes than the product actually contains.
Product
Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2346-2015·2015-08-12
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter Recall
Atrium Medical Corporation is recalling 620 units of 36Fr Right Angled Firm PVC Thoracic Catheters due to incorrect labeling on inner pouches.
Product
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1937-2015·2015-07-08
Atrium Medical Recalls Oasis Chest Drains Due to Missing O-Ring
Atrium Medical Corporation is recalling Oasis Dry Suction Water Seal Chest Drains because they have a missing o-ring. The recall covers 1,170 cases distributed nationwide and in Canada and Germany.
Product
Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1935-2015·2015-07-08
Atrium Medical Recalls Ocean Water Seal Chest Drains Due to Missing O-Ring
Atrium Medical Corporation is recalling Ocean Water Seal Chest Drains because they have a missing o-ring. The recall covers 390 cases distributed nationwide, in Canada, and in Germany.
Product
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1936-2015·2015-07-08
Atrium Medical Recalls Ocean Water Seal Chest Drains Due to Missing O-Ring
Atrium Medical Corporation is recalling Ocean Water Seal Chest Drains because they have a missing o-ring. The recall covers 130 cases distributed nationwide and in Canada and Germany.
Product
Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1938-2015·2015-07-08
Atrium Medical Recalls EXPRESS Dry Seal Chest Drains Due to Missing O-Ring
Atrium Medical Corporation is recalling EXPRESS Dry Seal Chest Drains because they have a missing o-ring. The recall affects 390 cases distributed in the US, Canada, and Germany.
Product
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1959-2014·2014-07-09
Atrium Express Dry Seal Chest Drain Recall Due to Leaking Risk
Atrium Medical Corporation is recalling 1,170 units of the Express Dry Seal Chest Drain ATS Blood Recovery because the tubing may leak or disconnect.
Product
Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-0743-2014·2014-01-22
Atrium Medical Recalls Chest Drain Tubing Due to Leak or Disconnect Risk
Atrium Medical Corporation is recalling 1,944 units of Express Dry Seal ATS Chest Drains because the tubing may leak or disconnect.
Product
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0737-2014·2014-01-22
Atrium Ocean Water Seal Chest Drain ATS Recall for Tubing Leaks
Atrium Medical Corporation is recalling 6,684 Ocean Water Seal Chest Drain ATS units because the chest drain tubing may leak or disconnect.
Product
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0742-2014·2014-01-22
Atrium Express Dry Seal ATS Chest Drain Recalled for Leak or Disconnect Risk
Atrium Medical Corporation is recalling 7,274 units of the Express Dry Seal ATS Chest Drain because the tubing may leak or disconnect.
Product
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

ATRIUM MEDICAL CORPORATION

Source: Wikidata (Q139903018), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.