The Recall Desk

Hazard

Non Sterile Packaging recalls

5 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2017-02-01

Of the 5 non sterile packaging recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all non sterile packaging recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–5 of 5

  • HighFDA (Devices)·Z-1081-2017·2017-02-01

    Atrium Medical Recalls Pediatric Ocean Drains Due to Non-Sterile Packaging

    Atrium Medical is recalling Pediatric Chamber Ocean Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2017·2017-02-01

    Atrium Medical Oasis Single Drain Recalled for Non-Sterile Packaging

    Atrium Medical is recalling Oasis Single Drains because the outer packaging is not sterile, posing a risk of infection.

    Product
    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…
    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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide