Recall archive / FDA device enforcement
SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18... — FDA record Z-1370-2024
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 Feb 21, 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
- SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15
- Reason
- Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigation syringes may increase infection risk.
- Classification
- Class II
- Recalling firm
- Alcon Research, LLC
- Quantity
- 886
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1370-2024
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 | Product/Lot/Expiration/UDI-DI: 18018-06/15T707/02/28/2025/380655148440, 3865-44/15T2RC/02/28/2025/380655148150, 5675-76/15T70E/02/28/2025/380655148174, 13554-11/15V4RC/02/28/2025/380655143711, 18018-06/15V3E0/02/28/2025/380655148440, 15190-16/JZ5179517/06/30/2024/380655148303, 15190-16/JZ5179519/06/30/2024/380655148303, 15190-16/JZ5179521/06/30/2024/380655148303, 15190-16/JZ5179523/06/30/2024/380655148303, 15190-16/JZ5179529/06/30/2024/380655148303, 13554-11/15TAUD/01/31/2026/380655143711, 5918-39/15TE5F/02/28/2025/380655149140, 15190-16/15THVA/04/30/2025/380655148303, 15190-16/15TNXJ/04/30/2025/380655148303, 9208-66/15V8CU/04/30/2025/380651693326, 9208-66/15XVDD/05/31/2025/380651693326, 5675-76/JZ5180811/06/30/2024/380655148174, 5918-39/JZ5180812/06/30/2024/380655149140, 9208-66/JZ5180332/03/31/2025/380651693326, 15190-16/JZ5180856/05/31/2025/380655148303, 9065-25/JZ5187593/11/30/2025/380651682849, 5918-39/JZ5187260/06/30/2024/380655149140, 16066-15/JZ5190913/07/31/2025/380655149683, 16066-15/JZ5191891/07/31/2025/380655149683 Bulb Syringe lots: 96922110001 or 96923100001 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of OH, WV.
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
- Apr 3, 2024
- Recall initiation date
- Feb 21, 2024
- Center classification date
- Mar 22, 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.