CLASS II ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report
Medline Contro-Bulb Syringe recalled by MEDLINE INDUSTRIES, LP
MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Contro-Bulb Syringe, distributed nationwide in the US. The recall was initiated on 4 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1157-2024
- FDA event ID
- 93795
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Jan 2024
- FDA classified
- 16 Feb 2024
- Reported
- 25 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 4 Jan 2024 | Recall initiated by company | |
| 16 Feb 2024 | Classified by FDA | +43 days |
| 25 Sep 2024 | Published in enforcement report | +222 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Where it was distributed
US, Nationwide
Questions about this recall
Is Medline Contro-Bulb Syringe recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Contro-Bulb Syringe on 4 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1157-2024.
Why was it recalled?
Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).
Which lots are affected?
UDI/DI 40080196031765 (case), 10080196031764 (unit) Lot Numbers: 96922110001 and 96923100001
Where was it sold?
US, Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS I | Medline medical convenience kits labeled as recalled | MEDLINE INDUSTRIES, LP - Northfield | Device Malfunction | 6 states |
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