CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report
ENDO KIT, Medline Kit recalled by MEDLINE INDUSTRIES, LP
Medline Industries LP - Northfield is recalling ENDO KIT, Medline Kit, distributed nationwide in the US. The recall was initiated on 25 Oct 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-0558-2025
- FDA event ID
- 95702
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Oct 2024
- FDA classified
- 26 Nov 2024
- Reported
- 4 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 25 Oct 2024 | Recall initiated by company | |
| 26 Nov 2024 | Classified by FDA | +32 days |
| 4 Dec 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.
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
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
Where it was distributed
US Nationwide distribution in the state of NY.
Questions about this recall
Why was it recalled?
Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.
Which lots are affected?
UDI-DI: 10193489844115 (each), 40193489844116 (case); Lot Number 22EBD372
Where was it sold?
US Nationwide distribution in the state of NY.
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 26 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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