Food, drugs, devices › MEDLINE INDUSTRIES, LP - Northfield
Device recall: Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
FDA enforcement event 89821 is a device recall by MEDLINE INDUSTRIES, LP - Northfield of Northfield, IL, initiated 9 Mar 2022 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 26 May 2026. Initiation: voluntary: firm initiated. MEDLINE INDUSTRIES, LP - Northfield has 120 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.
Reason for recall
"The mask cuff may disconnect from the device's breathing tube."
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0941-2022 | Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box | 8990 cases | Class II | Terminated | 20 Apr 2022 |
Context
Other enforcement events for MEDLINE INDUSTRIES, LP - Northfield
All 120 events for MEDLINE INDUSTRIES, LP - Northfield
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The mask cuff may disconnect from the device's breathing tube."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 May 2026. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.