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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75599

10 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 29, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Atrium Medical Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 10

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 in-line connector and suction control stopcock, Pre-connected 2550 ATS Bag 2002-100 Ocean single drain with in-line connector, no suction control stopcock 2002-300 Ocean single drain with suction control stopcock, no in-line connector 2002-400 Ocean single drain, no in-line connector or suction control stopcock, Water ampoule 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 blood from the patient s pleural cavity or mediastinal area.

Z-1079-2017
Recall number
Z-1079-2017
Initiated
November 29, 2016
Classification
Class II
Status
Terminated
Quantity
964,463 cases (US) 521,975 cases (OUS) in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Outer Packaging is not sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Outer Packaging is not sterile

Code information

All Lot Numbers With Expiration Date Prior To October 2019

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,

device · product 2 of 10

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 chamber with suction control stopcock, no in-line connector (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 collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.

Z-1080-2017
Recall number
Z-1080-2017
Initiated
November 29, 2016
Classification
Class II
Status
Terminated
Quantity
964,463 cases (US) 521,975 cases (OUS) in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Outer Packaging is not sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Outer Packaging is not sterile

Code information

All Lot Numbers With Expiration Date Prior To October 2019

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,

device · product 3 of 10

Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction control stopcock, ¿ in. Tubing, Sims and Pedi connector in bag on back of 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 blood from the patient s pleural cavity or mediastinal area.

Z-1081-2017
Recall number
Z-1081-2017
Initiated
November 29, 2016
Classification
Class II
Status
Terminated
Quantity
964,463 cases (US) 521,975 cases (OUS) in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Outer Packaging is not sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Outer Packaging is not sterile

Code information

All Lot Numbers With Expiration Date Prior To October 2019

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,

device · product 4 of 10

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 with in-line connector and suction control stopcock - 2 patient lines connected by one Y connector 2052-300 Ocean Double Blood Recovery drain with suction control stopcock, no in-line connector - 2 patient lines connected by one Y connector 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 blood from the patient s pleural cavity or mediastinal area.

Z-1082-2017
Recall number
Z-1082-2017
Initiated
November 29, 2016
Classification
Class II
Status
Terminated
Quantity
964,463 cases (US) 521,975 cases (OUS) in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Outer Packaging is not sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Outer Packaging is not sterile

Code information

All Lot Numbers With Expiration Date Prior To October 2019

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,

device · product 5 of 10

Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150 Oasis single drain with in-line connector and Pre-connected 2550 ATS Bag 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 blood from the patient s pleural cavity or mediastinal area.

Z-1083-2017
Recall number
Z-1083-2017
Initiated
November 29, 2016
Classification
Class II
Status
Terminated
Quantity
964,463 cases (US) 521,975 cases (OUS) in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Outer Packaging is not sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Outer Packaging is not sterile

Code information

All Lot Numbers With Expiration Date Prior To October 2019

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,

device · product 6 of 10

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 in bag on back of 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 blood from the patient s pleural cavity or mediastinal area.

Z-1084-2017
Recall number
Z-1084-2017
Initiated
November 29, 2016
Classification
Class II
Status
Terminated
Quantity
964,463 cases (US) 521,975 cases (OUS) in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Outer Packaging is not sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Outer Packaging is not sterile

Code information

All Lot Numbers With Expiration Date Prior To October 2019

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,

device · product 7 of 10

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 collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.

Z-1085-2017
Recall number
Z-1085-2017
Initiated
November 29, 2016
Classification
Class II
Status
Terminated
Quantity
964,463 cases (US) 521,975 cases (OUS) in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Outer Packaging is not sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Outer Packaging is not sterile

Code information

All Lot Numbers With Expiration Date Prior To October 2019

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,

device · product 8 of 10

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 from the chest cavity or mediastinum.  To help re-establish lung expansion and restore breathing dynamics.  To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.

Z-1086-2017
Recall number
Z-1086-2017
Initiated
November 29, 2016
Classification
Class II
Status
Terminated
Quantity
964,463 cases (US) 521,975 cases (OUS) in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Outer Packaging is not sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Outer Packaging is not sterile

Code information

All Lot Numbers With Expiration Date Prior To October 2019

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,

device · product 9 of 10

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 drain with in-line connector 4050-100P Express PreFilled Chest 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 blood from the patient s pleural cavity or mediastinal area.

Z-1087-2017
Recall number
Z-1087-2017
Initiated
November 29, 2016
Classification
Class II
Status
Terminated
Quantity
964,463 cases (US) 521,975 cases (OUS) in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Outer Packaging is not sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Outer Packaging is not sterile

Code information

All Lot Numbers With Expiration Date Prior To October 2019

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,

device · product 10 of 10

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 blood from the patient s pleural cavity or mediastinal area.

Z-1088-2017
Recall number
Z-1088-2017
Initiated
November 29, 2016
Classification
Class II
Status
Terminated
Quantity
964,463 cases (US) 521,975 cases (OUS) in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Outer Packaging is not sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Outer Packaging is not sterile

Code information

All Lot Numbers With Expiration Date Prior To October 2019

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,