The Recall Desk
HighFDA (Devices)·Z-1370-2024·Announced 2024-04-03

Alcon bulb irrigation syringes recalled due to sterile barrier compromise

Alcon is recalling bulb irrigation syringes due to potential sterile barrier compromise in surgical procedure packs. Non-sterile syringes may increase infection risk.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of medical devices with potential for sterile barrier compromise in surgical applications, presenting a risk of infection. No illnesses or injuries have been reported, and the hazard is based on potential rather than confirmed harm, which limits the score to High per the rubric.

Plain-English summary

Alcon Research, LLC is recalling bulb irrigation syringes (2 ounce/60 cubic centimeter, green, Part 300055070) that were packaged inside Alcon Custom-Pak Surgical Procedure Packs. Approximately 886 units have been recalled and distributed in Ohio and West Virginia.

The recall was initiated due to the potential for the sterile barrier in the packaging to be compromised. Because these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, the integrity of individual syringe packaging may not remain intact after the larger pack is opened for surgical use.

The use of non-sterile bulb irrigation syringes may increase the risk of infection during surgical procedures where sterility is critical. No illnesses or injuries have been reported to date.

Affected surgical facilities should discard the recalled syringes at the end of surgical cases rather than reshelving them for future use. Facilities should verify which surgical procedure packs contain affected syringe lots and ensure affected units are removed from inventory and discarded appropriately.

The recalled product

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,
Manufacturer
Alcon Research, LLC
Category
Medical Device — Surgical Irrigation Equipment
Hazard
  • sterile-barrier-compromise
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

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