Recall archive / FDA device enforcement
DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs — FDA record Z-2227-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 28, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
- Reason
- The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration date, however, the lubricating jelly (MDS032280) included in the DYNDP3000xxP series is labeled with an expiration date.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 9945 ea
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2227-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All Lots for series since product launch; Model Number (Unique Device Identifier) -DYND300010P (Each level packaging: 10193489010671; Case level packaging: 20193489010678); DYND300015P (Each level packaging: 10193489010688; Case level packaging: 20193489010685); DYND300020P (Each level packaging: 10193489010695; Case level packaging: 20193489010692); DYND300025P (Each level packaging: 10193489010701 Case level packaging: 20193489010708); DYND300030P (Each level packaging: 10193489010718; Case level packaging: 20193489010715); DYND300040P (Each level packaging: 10193489010725; Case level packaging: 20193489010722); DYND300050P (Each level packaging: 10193489010732; Case level packaging: 20193489010739) |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the country of Bermuda.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Aug 2, 2023
- Recall initiation date
- Mar 28, 2023
- Center classification date
- Jul 21, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.