Recall archive / FDA device enforcement
MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR ... — FDA record Z-0641-2025
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 Oct 9, 2024. 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
- MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-LF, REF DYNJ0826768P; 4) VAGINAL PACK, REF DYNJ59081C; 5)VAGINOPLASTY PACK, REF DYNJ65807C; 6) ACH MAJOR VAGINAL PACK, REF DYNJ67757B
- Reason
- Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1952 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0641-2025
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 | 1) REF CDS984955M, UDI/DI 10195327313302 (each) 40195327313303 (case), Lot Numbers: 23CBU078, 23HBG687, 23IBF280; 2) REF CDS984995M, UDI/DI 10195327043766 (each) 40195327043767 (case), Lot Numbers: 22GBA249, 23ABF616, 23ABF770, 23EBG938, 23CBD779, 23GBH707, 23KBU446, 23IBE467; 3) REF DYNJ0826768P, UDI/DI 10193489265699 (each) 40193489265690 (case), Lot Numbers: 22FMC589, 22DMI812, 23AMG530, 23FMI241, 23HMI199, 23JMF359; 4) REF DYNJ59081C, UDI/DI 10195327200404 (each) 40195327200405 (case), Lot Numbers: 22HBC733, 22LBL495, 23CBU862, 23BBF607, 23FBI028, 23EBU222, 23BBS154, 23GBI132, 23KBA604, 23JBE732; 5) REF DYNJ65807C, UDI/DI 10195327273668 (each) 40195327273669 (case), Lot Numbers: 23AMH550, 23DMD460, 23IMG365; 6) REF DYNJ67757B, UDI/DI 10195327228002 (each) 40195327228003 (case), Lot Numbers: 22HBH633, 22KBS878, 22JBF053, 23CBC829, 23BBH334 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
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
- Dec 11, 2024
- Recall initiation date
- Oct 9, 2024
- Center classification date
- Dec 5, 2024
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.