CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report
Medline Sterile Basic Eye Pack recalled by Medline Industries
Medline Industries is recalling Medline Sterile Basic Eye Pack 16, distributed in Missouri. The recall was initiated on 3 Oct 2025 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-0510-2026
- FDA event ID
- 97815
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Oct 2025
- FDA classified
- 14 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 3 Oct 2025 | Recall initiated by company | |
| 14 Nov 2025 | Classified by FDA | +42 days |
| 26 Nov 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
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 STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Where it was distributed
US: MO
Questions about this recall
Why was it recalled?
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
Which lots are affected?
1) REF: DYNJ37743D: UDI/DI 10193489600124 (each), 40193489600125 (case), Lot Number 25EMI333; 2) REF: DYNJ37743F: UDI/DI 10198459390685 (each), 40198459390686 (case), Lot Number 25GMD927.
Where was it sold?
US: MO
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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